Search

ASTM D6319 is the US standard specification for nitrile examination gloves intended for medical application. This certification interpretation guide explains the scope of ASTM D6319, its key test requirements, the FDA 510(k) clearance linkage, and how it compares to the European EN 455 series. Essential reading for procurement professionals sourcing gloves for the US healthcare market or dual-certifying products for both the US and EU. 1. What Is ASTM D6319? ASTM D6319, titled "Standard Specification for Nitrile Examination Gloves for Medical Application," is maintained by ASTM International (formerly American Society for Testing and Materials). First published in 1999, it is regularly revised to reflect current manufacturing practice and biocompatibility science. The standard establishes requirements for nitrile rubber gloves used in medical examinations, diagnostic procedures, and patient contact in healthcare settings. ASTM D6319 is recognized by the US FDA and is referenced as a consensus standard for 510(k) premarket notification submissions for medical examination gloves. Gloves that demonstrate compliance with ASTM D6319, along with biocompatibility testing per ISO 10993, are eligible for 510(k) clearance. 2. Scope and Application ASTM D6319 applies to nitrile rubber examination gloves used in medical examinations, diagnostic procedures, and patient contact. The standard covers five key attribute groups: Attribute Group What It Covers Test Reference Physical dimensions Length, width, palm thickness, finger thickness ASTM D6319 section 6 Physical properties Tensile strength, elongation at break before and after accelerated aging ASTM D6319 section 7 Freedom from holes Water leak test (AQL 1.5) ASTM D6319 section 8, ISO 2859-1 Powder residue Maximum powder amount (if labeled powder-free) ASTM D6319 section 9 Biocompatibility Cytotoxicity, sensitization, irritation (referenced to ISO 10993) ISO 10993 series 3. Key Test Requirements Physical Properties (Before and After Accelerated Aging) ASTM D6319 specifies tensile strength and elongation at break both before and after accelerated aging. The aging protocol is per ASTM D7160 or equivalent. Minimum values depend on the thickness category, but typical requirements are: Property Before Aging After Aging (7 days @ 70 degrees C) Test Reference Tensile strength >= 14 MPa >= 14 MPa ASTM D412 Elongation at break >= 500% >= 400% ASTM D412 Tensile strength (finger) >= 18 MPa >= 18 MPa ASTM D412 Freedom from Holes (Water Leak Test) The water leak test is the critical barrier integrity check. Gloves are filled with a defined volume of water and visually inspected for leaks. The Acceptable Quality Level (AQL) is 1.5, meaning the sample can have at most 1.5% defective units when sampled per ISO 2859-1 (equivalent to ANSI/ASQ Z1.4). Sampling plans typically reference General Inspection Level I or II with single sampling. The water leak test is harmonized with EN 455-1, meaning gloves that pass one test generally pass both. Dual-certified gloves typically use the same leak test method. Powder Residue Limit ASTM D6319 limits the powder residue on powder-free gloves to 2 mg per glove maximum. The test method fills the glove with water and rinses, then evaporates the rinsate and weighs the residue. Powdered gloves have no residue limit under ASTM D6319, but FDA regulations and purchaser requirements increasingly favor powder-free products. 4. Biocompatibility Requirements (ISO 10993) ASTM D6319 does not specify biocompatibility test methods itself but requires that the glove pass cytotoxicity, sensitization, and irritation tests per the ISO 10993 series. Typically, the following tests are required: Test Purpose Method Reference Cytotoxicity (MEM elution) Detect cell-killing substances ISO 10993-5 Sensitization (LLNA or GPMT) Detect allergic contact dermatitis potential ISO 10993-10 Irritation (intracutaneous reactivity) Detect skin irritation potential ISO 10993-10 Acute systemic toxicity (optional) Detect systemic toxic effects ISO 10993-11 Testing must be performed on the finished glove, not just the raw nitrile rubber. A change in formulation (different accelerator, plasticizer, pigment) typically requires re-testing per ISO 10993. 5. ASTM D6319 vs EN 455 Comparison ASTM D6319 and EN 455 (series 1-4) both certify nitrile examination gloves for medical use. For dual-certified products, the differences are minor but worth understanding. Requirement ASTM D6319 EN 455 Series Region of recognition US (FDA 510(k)) EU (MDR 2017/745) Freedom from holes AQL 1.5 1.5 (EN 455-1) Tensile strength (before aging) >= 14 MPa >= 7 MPa (EN 455-2) Elongation (before aging) >= 500% >= 500% (EN 455-2) Powder residue limit <= 2 mg/glove (powder-free) <= 2 mg/glove (EN 455-3 powder-free) Protein content limit Not applicable (nitrile) <= 50 microg/g for latex; not applicable to nitrile Biocompatibility ISO 10993 required ISO 10993 required (EN 455-3) Shelf life determination ASTM D7160 EN 455-4 The most notable difference is tensile strength: ASTM D6319 requires a minimum of 14 MPa before aging (and same after aging), while EN 455-2 requires only 7 MPa before aging. ASTM D6319 is more stringent on tensile strength, which is one reason many manufacturers dual-certify to ASTM D6319 first and then add EN 455. 6. FDA 510(k) Clearance Process To market nitrile examination gloves in the US, manufacturers must obtain FDA 510(k) clearance. The 510(k) pathway requires: Predicate device identification: Demonstrate substantial equivalence to a legally marketed predicate device. Performance testing: Compliance with ASTM D6319 (plus biocompatibility per ISO 10993). Labeling review: Compliance with 21 CFR 801 (medical device labeling). Quality system: Manufacturing under FDA Quality System Regulation (21 CFR 820, transitioning to QSR harmonized with ISO 13485). User fee: Standard FDA user fee (currently approximately $24,000 for a 510(k) submission, with small-business discounts available). After clearance, the glove is listed in the FDA 510(k) database with the K-number. Importers and distributors should verify the K-number on each shipment's documentation. 7. Procurement Checklist for ASTM D6319 Gloves Verify FDA 510(k) clearance - Check the FDA 510(k) database for an active K-number for the glove model. Request the ASTM D6319 test report - Confirm compliance with physical properties, water leak, and powder residue limits. Request the ISO 10993 biocompatibility report - Confirm cytotoxicity, sensitization, and irritation test results on the finished glove. Verify shelf life data - Request ASTM D7160 or EN 455-4 accelerated aging test results. Typical nitrile rubber glove shelf life is 3-5 years under proper storage. Confirm AQL 1.5 sampling - Request batch-level AQL test reports with each shipment. Verify labeling compliance - Check 21 CFR 801 labeling: size, intended use, manufacturer, expiration date, lot number, storage conditions. Confirm US agent representation - Foreign manufacturers must designate a US Agent for FDA correspondence. Audit the manufacturer - For high-volume procurement, conduct an on-site or remote audit covering ISO 13485 quality system and ASTM D6319 production controls. FAQ Q: What is ASTM D6319 and what products does it cover? A: ASTM D6319 is the US standard specification for nitrile examination gloves for medical application. It establishes requirements for nitrile rubber gloves used in medical examinations, diagnostic procedures, and patient contact. The standard covers physical properties, dimensions, freedom from holes (water leak test), powder residue, and protein content. ASTM D6319 is referenced by the US FDA for 510(k) premarket notification clearance of medical examination gloves. Q: How does ASTM D6319 differ from EN 455 for nitrile examination gloves? A: ASTM D6319 and EN 455 series (EN 455-1, 455-2, 455-3, 455-4) both certify nitrile examination gloves for medical use, but they are regional standards. ASTM D6319 is recognized in the US (with FDA 510(k) clearance) while EN 455 is required in the EU under the Medical Device Regulation (MDR 2017/745). Many manufacturers dual-certify to access both markets. Key test differences include slightly different AQL sampling plans and protein-content limits (EN 455 limits latex protein; ASTM D6319 focuses on nitrile-specific biocompatibility per ISO 10993). Q: What AQL does ASTM D6319 require? A: ASTM D6319 sets the maximum Acceptable Quality Level (AQL) for freedom from holes (water leak test) at 1.5, in line with EN 455-1 and the general medical examination glove standard. The standard requires sampling per ISO 2859-1 (equivalent to ANSI/ASQ Z1.4). Some manufacturers voluntarily meet AQL 0.65 for surgical-grade applications. Batch-level AQL test reports are the standard requirement for procurement verification. Q: Does ASTM D6319 require biocompatibility testing? A: Yes. ASTM D6319 defers biocompatibility testing to ISO 10993 (Biological evaluation of medical devices). For nitrile examination gloves, the typical panel includes cytotoxicity, sensitization, and irritation tests. Test reports must reference the specific material formulation. A change in formulation (different accelerator, plasticizer, or pigment) may require re-testing under ISO 10993. Q: What packaging and labeling requirements does ASTM D6319 specify? A: ASTM D6319 requires that each glove be properly labeled with size, intended use (medical examination), and the manufacturer's identification. The packaging must include the expiration date (determined per ASTM D7160 or equivalent accelerated aging protocol), storage conditions, and any applicable warnings. For US sale, the label must also comply with FDA 21 CFR 801 (medical device labeling). Cartons must include the lot number for traceability.

ASTM and EN are the two most important standards families for disposable nitrile gloves. This cheat sheet compares key standards, test methods, AQL requirements, and physical property specs side by side, so buyers can understand what dual certification requires. ASTM International and the European Committee for Standardization (CEN) are the two primary standards bodies governing disposable medical gloves. ASTM D6319 is the US standard for nitrile examination gloves; EN 455 is the European standard for medical gloves for single use. Manufacturers selling to both the US and EU must understand the differences and achieve dual certification. This cheat sheet compares the two standards side by side. 1. Key ASTM Standards for Disposable Gloves ASTM standard Title Material ASTM D6319 Nitrile Examination Gloves for Medical Application Nitrile rubber ASTM D3578 Rubber Examination Gloves Natural rubber latex ASTM D5250 Polyvinyl Chloride Examination Gloves PVC ASTM D3577 Rubber Surgical Gloves Natural rubber latex / nitrile ASTM D6978 Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs Any 2. Key EN Standards for Disposable Gloves EN standard Title Scope EN 455-1 Medical gloves for single use - Part 1: Freedom from holes AQL and water leak test EN 455-2 Part 2: Physical properties Force at break requirements EN 455-3 Part 3: Biological evaluation Cytotoxicity, sensitization, irritation EN 455-4 Part 4: Shelf life determination Accelerated and real-time aging EN ISO 21420 Protective gloves - General requirements (formerly EN 420) pH, innocuousness, sizing, dexterity EN 374-1 to -5 Protective gloves against chemicals and micro-organisms Permeation, penetration, degradation 3. Side-by-Side: ASTM D6319 vs EN 455 for Nitrile Gloves Parameter ASTM D6319 (US) EN 455 series (EU) Governing body ASTM International CEN (European Committee for Standardization) Regulatory pathway FDA 510(k) clearance EU MDR (2017/745) via Notified Body Hole freedom test Water leak test, AQL 1.5 EN 455-1: Water leak test, AQL 1.5 Tensile strength (before aging) >= 14 MPa Not specified as MPa; EN 455-2 uses force at break Tensile strength (after aging) >= 14 MPa Not specified as MPa; force at break applies Elongation before aging >= 500% Not specified in EN 455-2 Elongation after aging >= 400% Not specified in EN 455-2 Force at break (exam gloves) Not specified in force (uses tensile strength) EN 455-2: >= 6.0 N (rubber); >= 3.6 N (thermoplastic) Force at break (surgical) Not specified (ASTM D3577 covers surgical) EN 455-2: >= 9.0 N Biological evaluation ISO 10993 series (cytotoxicity, sensitization, irritation) EN 455-3: ISO 10993 series (same test framework) Shelf life Manufacturer-defined with supporting data EN 455-4: accelerated aging + real-time stability testing required Sampling for AQL ANSI/ASQ Z1.4 (equivalent to ISO 2859-1) ISO 2859-1 4. Key Differences in Testing Approach The most important difference between ASTM and EN is how they measure physical properties. ASTM D6319 specifies tensile strength in megapascals (MPa) and elongation percentage. EN 455-2 specifies force at break in newtons (N) but does NOT specify tensile strength in MPa or elongation. This means a glove could pass one standard but not the other depending on its material formulation: ASTM approach: tensile strength and elongation on dumbbell-shaped specimens cut from the glove EN approach: force at break on a strip cut from the glove, measured in newtons Result: a nitrile glove with tensile strength of 16 MPa may have a force at break that varies with specimen width and thickness For biological evaluation, both ASTM and EN reference the ISO 10993 series, so the testing framework is aligned. The difference is in regulatory documentation: the US requires FDA 510(k) submission, while the EU requires CE marking via a Notified Body under the EU MDR. 5. AQL and Sampling Comparison Aspect ASTM / FDA (US) EN 455-1 (EU) Acceptable Quality Level AQL 1.5 for major defects (pinholes) AQL 1.5 for pinholes Premium grades Some manufacturers offer AQL 0.65 Some manufacturers offer AQL 0.65 Sampling standard ANSI/ASQ Z1.4 ISO 2859-1 Test method Water leak test (1000 mL water, 2-5 sec) Water leak test (1000 mL water, 2-5 sec) Batch release Per 21 CFR 800 + ASTM standards Per EN 455-1 + ISO 2859-1 6. Documentation Requirements for Dual Certification Requirement US (FDA 510(k)) EU (EU MDR / CE marking) Quality system 21 CFR 820 (QSR) or ISO 13485 ISO 13485 mandatory Technical file 510(k) premarket notification Technical documentation per EU MDR Annex II/III Biocompatibility ISO 10993 test reports EN 455-3 / ISO 10993 test reports Performance testing ASTM D6319 test report EN 455-1 to -4 test reports Risk management ISO 14971 (recommended) ISO 14971 (mandatory per EU MDR) Labeling English, per 21 CFR 801 Language of member state + CE mark UDI Required per FDA UDI rule Required per EU MDR UDI Post-market FDA MedWatch reporting EUDAMED registration and vigilance 7. Dual Certification Roadmap Design for both: specify nitrile rubber formulation that meets both ASTM D6319 (tensile >= 14 MPa, elongation >= 500%/400%) and EN 455-2 (force at break >= 6.0 N) Implement ISO 13485: this satisfies both FDA QSR expectations and EU MDR requirements Conduct ISO 10993 testing: biocompatibility data is accepted by both FDA and EU Notified Bodies Perform AQL testing: use ISO 2859-1 sampling (accepted by both ASTM and EN) Compile US technical file: 510(k) with ASTM D6319 performance data Compile EU technical file: EU MDR Annex II/III with EN 455-1 to -4 data Assign regulatory representatives: US Agent for FDA, Authorized Representative for EU Submit and maintain: register with FDA and obtain CE marking; update both files for any design or material changes Data sources: ASTM D6319-19; ASTM D3577; ASTM D3578; ASTM D5250; ASTM D6978; EN 455-1 to EN 455-4; EN ISO 21420:2020 (formerly EN 420); EN 374-1 to -5; EU MDR 2017/745; FDA 21 CFR 820; FDA 21 CFR 801; ISO 13485; ISO 14971; ISO 10993 series; ISO 2859-1; ANSI/ASQ Z1.4. Information current as of September 2026. FAQ Q: What is the main difference between ASTM and EN glove standards? A: The main difference is in how they measure physical properties. ASTM D6319 specifies tensile strength in megapascals (MPa) and elongation as a percentage. EN 455-2 specifies force at break in newtons (N) but does not set tensile strength or elongation requirements. Both use the same water leak test for AQL 1.5 and reference ISO 10993 for biocompatibility, but the regulatory pathways differ: FDA 510(k) for the US and CE marking via a Notified Body for the EU. Q: Can one glove meet both ASTM and EN requirements? A: Yes, many nitrile rubber gloves are dual-certified. A glove with tensile strength >= 14 MPa and elongation >= 500%/400% will typically also meet the EN 455-2 force at break requirement of >= 6.0 N for rubber examination gloves, because the two tests measure related properties through different methods. Manufacturers must conduct testing under both standards and maintain separate technical files for FDA 510(k) and EU MDR CE marking. Q: Which ASTM standard applies to nitrile examination gloves? A: ASTM D6319 is the US standard for nitrile examination gloves for medical application. It specifies tensile strength (>= 14 MPa before and after aging), elongation (>= 500% before aging, >= 400% after aging), dimensions, and AQL 1.5 for pinholes. For nitrile surgical gloves, ASTM D3577 applies. For chemotherapy drug permeation testing, ASTM D6978 applies. Q: What does EN 455-2 test that ASTM D6319 does not? A: EN 455-2 specifies force at break (measured in newtons) for different glove types: >= 6.0 N for rubber examination gloves, >= 3.6 N for thermoplastic (PVC/PE) examination gloves, and >= 9.0 N for surgical gloves. ASTM D6319 does not specify force at break in newtons; instead it uses tensile strength in MPa and elongation percentage. Conversely, ASTM D6319 specifies elongation, which EN 455-2 does not. Q: Do I need both certifications to sell in the US and EU? A: Yes, to sell medical gloves in both markets, you need both FDA 510(k) clearance (with ASTM D6319 compliance) for the US and CE marking (with EN 455 compliance) under the EU MDR for Europe. The two regulatory systems are independent. However, much of the underlying test data (ISO 10993 biocompatibility, AQL water leak testing, ISO 13485 quality system) can be shared between the two submissions.