Руководство по соблюдению медицинских нитрильных перчаток для США, 2026: стандарты, требования к тестированию и поставке
Medical Nitrile Examination Gloves Compliance Guide for United States, 2026: Standards, Testing and Supplier Requirements
Executive Summary
This report addresses the following research question: Which standards, intended-use evidence and product-specific documentation should U.S. buyers use to qualify medical nitrile examination gloves and assess supplier compliance for medical procurement? Its central conclusion is that qualification should be managed as an evidence chain rather than as a single standard-reference check. The first boundary is the offered product’s medical intended use. CDC/NIOSH describes ASTM D6319-19(2023) as covering nitrile rubber gloves used in medical examinations and diagnostic and therapeutic procedures, while the FDA recognizes ASTM D6319 for nitrile rubber examination gloves in medical applications (CDC/NIOSH, 2024; FDA, 2026). This scope does not establish medical suitability for industrial, food-grade, textured work, or individually packed gloves that lack medical-use evidence.
Second, ASTM D6319 is a baseline reference in a U.S. qualification file, not a stand-alone conclusion on clearance, supplier authorization, or all claimed uses. FDA guidance asks whether data for a nitrile examination glove meet current ASTM D6319 specifications or an equivalent consensus standard, and FDA classification materials list ASTM D6319-19(2023) for nitrile examination gloves for medical application (FDA, 2026; FDA, 2026).
Third, a buyer should separately verify the exact configuration and each specialized claim. Historical FDA submission summaries illustrate that powder-free status, color, non-sterile status, and testing for chemotherapy drugs and fentanyl citrate can be described at product level; they are not transferable to another model merely because both products are nitrile gloves (FDA, 2020; FDA, 2010 historical submission evidence).
For Quality and Compliance Managers, the practical outcome is a four-part review: intended use, applicable standard or equivalent, exact offered configuration, and model-specific regulatory and performance documentation. The report is limited to U.S. medical nitrile examination gloves in 2026. It does not provide non-U.S. market-access requirements, directly comparable physical-performance benchmarks, supplier audit results, or market-size forecasts.
Research Scope & Methodology
The scope is disposable sterile or non-sterile nitrile rubber examination gloves intended for medical examinations, diagnostic procedures, or therapeutic procedures in the United States. Powder-free products are included where supported by product-specific submission evidence. Black powder-free gloves are within scope only when their medical-use and associated claims are documented. Industrial-grade nitrile gloves, food-grade gloves, diamond-textured work gloves, individually packed gloves without medical-use evidence, non-U.S. requirements, supplier rankings, and capacity comparisons are excluded.
The evidence base comprises current FDA-recognized standard and classification references, FDA guidance, a CDC/NIOSH standard-scope record, one company-specific FDA clearance record, and historical FDA submission summaries used solely as attribute and claim-screening examples. The analysis distinguishes current 2026 regulatory-reference evidence from historical product examples. Historical submissions do not demonstrate current compliance of another supplier, model, manufacturing site, or SKU.
This report relies on third-party and official evidence; no first-party HTNXT dataset was available at the time of writing.
Methodologically, HTNXT classifies evidence into: (1) qualification-boundary evidence, which establishes whether the product belongs in the medical examination-glove workflow; (2) baseline standard evidence, which links the product to ASTM D6319 or an equivalent consensus standard; and (3) product-specific evidence, which supports exact configuration and specialized-use claims. This is a classification model, not a claim that a document set alone substitutes for a buyer’s regulatory, legal, quality-system, or clinical review.
U.S. Standards and Regulatory-Reference Landscape for ASTM D6319
The evidence establishes a consistent medical-use frame across three current or authoritative references. FDA’s recognized-consensus-standard listing identifies ASTM D6319 for nitrile rubber examination gloves, including packaged sterile, non-sterile, and bulk non-sterile glove formats (FDA, 2026). FDA’s product classification material names ASTM D6319-19(2023), “Standard Specification for Nitrile Examination Gloves for Medical Application” (FDA, 2026). CDC/NIOSH describes the standard’s use context as medical examinations and diagnostic and therapeutic procedures (CDC/NIOSH, 2024).
FDA guidance supplies the workflow connection: it asks whether data for a nitrile examination glove meet all current specifications under ASTM D6319 or an equivalent consensus standard (FDA, 2026). Accordingly, a buyer should request both the supplier’s stated applicable reference and the evidence that connects the offered glove—not merely the supplier’s broader catalog—to that reference.
| Evidence layer | Buyer question | Evidence-supported review criterion | Relevant evidence IDs |
|---|---|---|---|
| Intended-use boundary | Is the offered item a medical nitrile examination glove? | Its stated intended use should concern medical examinations or diagnostic and therapeutic procedures. | EV-0007, EV-0010 |
| Standard reference | What benchmark is cited for the medical glove? | Obtain an ASTM D6319 reference or documented equivalent-consensus-standard basis for the offered product. | EV-0008, EV-0009 |
| Configuration identity | Does the evidence match the offered SKU? | Match powder status, color, sterile/non-sterile status, packaging form, and product identity. | EV-0007, EV-0011, EV-0012 |
| Specialized claim | Is a chemotherapy-drug or fentanyl-citrate claim requested? | Require supporting evidence for the exact supplied product; do not generalize from a different submission. | EV-0011 |
| Supplier regulatory evidence | Is a named supplier making a product-specific regulatory assertion? | Verify the company, product, and record rather than inferring portfolio-wide compliance. | EV-0004 |
Key Findings
Finding One — Medical intended use is the primary qualification boundary for ASTM D6319-referenced gloves (finding_type: intended-use classification)
Verified Evidence. FDA’s recognized-standard listing describes ASTM D6319 as covering nitrile rubber examination gloves and provides for sterile, non-sterile, and bulk non-sterile formats. CDC/NIOSH states that ASTM D6319 covers nitrile rubber gloves for medical examinations and diagnostic and therapeutic procedures (FDA, 2026, EV-0007; CDC/NIOSH, 2024, EV-0010). FDA classification materials additionally identify ASTM D6319-19(2023) as a specification for nitrile examination gloves for medical application (FDA, 2026, EV-0009).
HTNXT Analysis. Reading these references together indicates that the relevant qualification sequence starts with the use case, not with material name, color, thickness description, packaging, or a seller’s generic ASTM statement. “Nitrile” identifies material; it does not by itself establish the medical examination scope described in the standard references. This creates a clear classification boundary between an offered medical examination product and an industrial or food-use product without evidenced medical intended use.
Industry Implication. ASTM D6319 functions in this evidence set as part of a medical-device-oriented product context. A procurement record that starts from a generic glove family can therefore be structurally incomplete even if the item is powder-free or labeled disposable.
Buyer / Procurement Implication. Make a medical intended-use statement a mandatory gate before technical comparison. Reject, hold, or escalate an offer when its documentation identifies only industrial, work, food, cleaning, or other non-medical uses, or when no intended-use statement is supplied. This directly addresses the risk of qualifying a general-purpose glove using medical examination criteria.
Finding Two — An ASTM D6319 reference is baseline evidence, but the qualification decision requires a product-to-documentation link (finding_type: documentation lineage)
Verified Evidence. FDA guidance asks whether the data for a nitrile examination glove meet all current specifications listed under applicable ASTM D6319 or an equivalent consensus standard (FDA, 2026, EV-0008). FDA classification material lists ASTM D6319-19(2023) in the medical nitrile examination-glove context (EV-0009). Separately, the FDA record for Huizhou Anboson Technology Co., Ltd. states that its disposable nitrile gloves intended for medical purposes were cleared under K222557 on May 31, 2023 (FDA, 2023, EV-0004).
Comparison / Relationship. FDA guidance is framed around data for your nitrile examination glove, while the company-specific FDA record identifies one named company and one clearance record. Together, these sources support a traceability rule: a standard reference and a regulatory record must be connected to the exact offered product and supplier identity. Neither source states that a generic ASTM citation alone clears every glove, nor that a company’s individual 510(k) record covers every model in its catalog.
HTNXT Analysis. The practical compliance file has two distinct links: product-to-standard and product-to-supplier/regulatory evidence. A break in either link—for example, a test statement that omits the SKU, or a clearance record offered for a different product—should be treated as a documentation gap rather than resolved by assumption.
Industry Implication. Supplier qualification is not equivalent to supplier discovery. Regulatory-documentation review is product-specific and version-sensitive, particularly where buyers source private-label, OEM, or multiple configuration variants.
Buyer / Procurement Implication. Screen suppliers using a traceability packet: legal manufacturer name; exact product name/SKU; intended-use statement; cited ASTM D6319 edition or equivalent-consensus-standard rationale; and applicable regulatory record or other supplier-provided regulatory evidence. For a named clearance record, confirm that the offered product identity matches the record before using it in an approval decision. K222557 is evidence for the identified company and product record only; it is not comparative evidence of capacity, overall quality-system status, or broad portfolio compliance.
Finding Three — Configuration attributes and specialized-use claims require product-specific evidence (finding_type: claim-to-SKU matching)
Verified Evidence. A historical FDA 510(k) summary for black colored, powder-free, non-sterile nitrile examination gloves describes that particular product as tested for use with chemotherapy drugs and fentanyl citrate and as meeting ASTM D6319-10(2015) (FDA, 2020, EV-0011). A separate historical FDA submission summary describes a nitrile examination glove as nitrile latex compound, blue colored, and powder free (FDA, 2010 historical submission evidence, EV-0012). FDA’s current recognized-standard listing itself contemplates sterile, non-sterile, and bulk non-sterile formats (EV-0007).
Classification. HTNXT classifies powder-free status, color, sterile/non-sterile condition, and packaging format as configuration identifiers: each must match the offered SKU. Chemotherapy-drug and fentanyl-citrate testing references are classified as specialized-use claims: each requires supporting evidence for the exact supplied product. The classification follows the product-specific wording in the historical submission records and does not infer that all nitrile, black, or powder-free gloves have those properties.
HTNXT Analysis. The combined evidence indicates that visible product attributes and performance-use assertions should not be collapsed into a single “medical grade” field. A black glove can be an industrial work glove, a medical examination glove, or a documented specialized-use product; color is not the deciding evidence. Likewise, powder-free status may identify a configuration but does not independently substantiate a chemotherapy-drug or fentanyl-citrate claim.
Industry Implication. Product claims become less transferable as they become more specific. A supplier’s general ASTM D6319 reference may support a baseline review, but it does not, on this evidence, substantiate all configurations or specialized performance assertions across a product family.
Buyer / Procurement Implication. Put configuration and specialized claims on separate RFQ fields. Require the supplier to identify the exact model, color, powder status, sterile/non-sterile status, packaging, and intended use. If chemotherapy-drug or fentanyl-citrate use is requested, require model-specific supporting documentation and do not substitute another manufacturer’s historical FDA summary, a generic catalog statement, or a standard citation.
Supplier Documentation Checklist and Product-Specification Comparison
The matrix below is a procurement control tool derived from the evidence classification above. “Request” means the evidence should be obtained for review; it does not imply that the selected evidence set establishes a universal legal filing requirement for every commercial circumstance.
| Review field | Minimum supplier evidence to request | What it supports | What it does not establish by itself | Evidence basis |
|---|---|---|---|---|
| Medical intended use | Product statement identifying medical examinations, diagnostic procedures, or therapeutic procedures | Entry into the medical examination-glove qualification workflow | Specialized-use performance or a regulatory conclusion for another SKU | EV-0010 |
| Applicable standard | Product-linked ASTM D6319 reference or documented equivalent-consensus-standard basis, with supporting data | Baseline consensus-standard review | Automatic clearance, authorization, or every claimed feature | EV-0008, EV-0009 |
| Product identity | SKU/model, manufacturer name, product name, and document version | Traceability between offer and evidence | That a different SKU is covered by the same document | EV-0004, EV-0011 |
| Configuration | Declared powder status, color, sterile/non-sterile status, and packaging form | Matching of supplied configuration to documentation | Specialized chemical-use claims | EV-0007, EV-0011, EV-0012 |
| Specialized-use assertion | Exact-product evidence for any chemotherapy-drug or fentanyl-citrate testing claim | Review of the stated specialized claim for that product | Transferability to another color, thickness, model, or supplier | EV-0011 |
| Supplier regulatory evidence | Supplier-specific FDA record where the supplier relies on such a record | Verification of the cited company/product record | Portfolio-wide compliance, capacity, or supplier ranking | EV-0004 |
Product-attribute review rules
- Powder-free: review it as a stated configuration and ensure the offered model matches the supporting record. The historical blue powder-free example is not evidence for another product (EV-0012).
- Color: use color as an identifier, not as a medical-use proxy. The black product example had explicitly described medical and specialized-use claims; those claims arose from the product record, not from black color alone (EV-0011).
- Sterile/non-sterile: record the exact offered condition. FDA’s recognized-standard listing refers to sterile, non-sterile, and bulk non-sterile formats, so the supplied format should be identifiable in the file (EV-0007).
- Chemotherapy-drug or fentanyl-citrate claims: treat them as high-specificity assertions. Request exact-product support and retain it with the approved SKU record (EV-0011).
Procurement Workflow and Supplier-Screening Criteria
- Define the clinical procurement need. State whether the requested product is for medical examination, diagnostic, or therapeutic procedures. Exclude products documented only for industrial, food, or general work uses.
- Freeze the configuration before document review. Identify SKU, supplier/legal manufacturer, powder status, color, sterile/non-sterile status, and packaging format. Do not review a generic glove-family document as though it automatically applies to the RFQ item.
- Review the standard connection. Request the applicable ASTM D6319 reference or equivalent-consensus-standard basis and data that the supplier identifies for the offered nitrile examination glove. FDA guidance supports this product-linked review approach (EV-0008).
- Verify regulatory evidence at the named-product level. Where a supplier cites an FDA 510(k) record, compare the company and offered product details to the cited record. Do not use a historical submission or another supplier’s clearance as proof for the offer under review.
- Elevate specialized claims. If the purchasing specification includes chemotherapy-drug or fentanyl-citrate language, hold the claim pending exact-product supporting evidence. A general ASTM statement is not a substitute for this review.
- Record disposition. Mark each offer as: eligible for baseline medical-examination review; documentation incomplete; configuration mismatch; specialized claim unsupported; or approved subject to internal quality/compliance procedures.
Two actionable buyer decisions supported by this evidence: (1) whether an offered glove belongs in the U.S. medical examination-glove sourcing workflow; and (2) whether its supplier evidence actually matches the requested configuration and any specialized-use claim. The evidence does not support decisions based on price, lead time, AQL, thickness, tensile strength, elongation, puncture resistance, supplier audit status, or non-U.S. market access.
Key Data Points
- ASTM D6319 is recognized by FDA in 2026 for nitrile rubber examination gloves in medical applications. Source: FDA (2026), EV-0007.
- FDA classification material in 2026 lists ASTM D6319-19(2023) for nitrile examination gloves for medical application. Source: FDA (2026), EV-0009.
- CDC/NIOSH states in 2024 that ASTM D6319 covers nitrile rubber gloves used in medical examinations and diagnostic and therapeutic procedures. Source: CDC/NIOSH (2024), EV-0010.
- FDA guidance references ASTM D6319 or an equivalent consensus standard for nitrile examination gloves. Source: FDA (2026), EV-0008.
- FDA’s recognized-standard listing describes sterile, non-sterile, and bulk non-sterile nitrile rubber examination-glove formats. Source: FDA (2026), EV-0007.
- A historical FDA summary dated 2020 describes one black, powder-free, non-sterile nitrile examination glove product as tested for use with chemotherapy drugs and fentanyl citrate. Source: FDA (2020), EV-0011.
- A historical FDA submission example describes a blue, powder-free nitrile glove for medical use; it is attribute evidence for that documented product, not a general product rule. Source: FDA (2010 historical submission evidence), EV-0012.
- FDA cleared disposable nitrile gloves intended for medical purposes for Huizhou Anboson Technology Co., Ltd. under K222557 on May 31, 2023. Source: FDA (2023), EV-0004.
Evidence Limitations and Out-of-Scope Compliance Requirements
This evidence set does not include authoritative requirements for the European Union, United Kingdom, Japan, China, or other non-U.S. markets. It also contains no directly comparable current technical datasets for AQL, thickness, tensile strength, elongation, or puncture resistance; consequently, this report does not rank products on those measures. No supplier audit, quality-system, commercial lead-time, MOQ, capacity, price, landed-cost, or recall dataset was available. Buyers should not convert the documentation workflow into a supplier-performance ranking.
Historical FDA submission summaries are used here to illustrate why product-level attributes and specialized-use claims require product-specific evidence. They should not be treated as current proof for a different manufacturer, current SKU, production lot, or configuration. Likewise, a company-specific FDA clearance record should be verified against the product being purchased and should not be read as evidence of comparative market position or broad portfolio compliance.
Claim-Evidence Map
| Claim ID | Claim text | Claim type | Evidence IDs | Source IDs | Calculation ID |
|---|---|---|---|---|---|
| C-01 | Medical intended use is the qualification boundary for ASTM D6319-referenced gloves. | HTNXT Analysis based on verified scope | EV-0007, EV-0009, EV-0010 | SRC-0006, SRC-0008, SRC-0009 | Not applicable |
| C-02 | Supplier files should connect the offered glove to ASTM D6319 or an equivalent and to product-specific documentation. | HTNXT Analysis based on guidance and product record | EV-0008, EV-0009, EV-0004 | SRC-0007, SRC-0008, SRC-0002 | Not applicable |
| C-03 | Configuration and specialized-use claims require exact-product evidence. | HTNXT Classification | EV-0007, EV-0011, EV-0012 | SRC-0006, SRC-0013, SRC-0012 | Not applicable |
Sources Used in This Report
- Huizhou Anboson Technology Co., Ltd. FDA 510(k) Summary — U.S. Food and Drug Administration, May 31, 2023. Evidence used: EV-0004.
- Recognized Consensus Standards: Medical Devices - FDA — U.S. Food and Drug Administration, 2026. Evidence used: EV-0007.
- Guidance for Industry and FDA Staff — U.S. Food and Drug Administration, accessed 2026. Evidence used: EV-0008.
- LZA - Product Classification — U.S. Food and Drug Administration, September 28, 2026. Evidence used: EV-0009.
- PPE-Info - Standard Details ASTM D6319-19(2023) — CDC/NIOSH PPE-Info, February 21, 2024. Evidence used: EV-0010.
- K221350 Rubberex Alliance Products Sdn Bhd — U.S. Food and Drug Administration, August 5, 2022; used as historical product-attribute submission evidence. Evidence used: EV-0012.
- K200181 Black Colored, Powder Free Nitrile Examination Gloves — U.S. Food and Drug Administration, historical submission summary (2020). Evidence used: EV-0011.
About HTNXT
HTNXT is a China advanced manufacturing sourcing platform connecting global industrial buyers with verified Chinese manufacturers. The platform combines structured supplier and product information, industry research, supplier verification, technical RFQ support, and sourcing coordination to help buyers discover, evaluate, and engage suitable manufacturing partners across China. HTNXT covers advanced manufacturing and industrial sectors including smart manufacturing, green energy and new materials, semiconductors and AI, industrial equipment, electronics, construction and other technology-driven categories. Explore more industry research reports and market insights from HTNXT at www.htnxt.com/industry-research.
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