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D6319-19 – Standard Test Method Technical Guide
📜 Scope and Application
ASTM D6319-19 (Reapproved 2023) provides a comprehensive referee specification for nitrile rubber gloves intended for use in medical examinations, diagnostics, and therapeutic procedures. This standard covers single-use gloves designed to fit either hand, paired gloves, and a variety of sizes. It encompasses both packaged sterile, non-sterile, and bulk non-sterile formats, ensuring applicability across a broad range of clinical environments.
All values stated in this specification are in SI units, which are regarded as standard. This specification is closely related to ASTM D3578 (Specification for Rubber Examination Gloves) but is uniquely tailored to the performance characteristics of nitrile polymers. The document also references several key ASTM standards including D412 (Tension Testing), D573 (Air Oven Aging), D3767 (Dimension Measurement), D5151 (Hole Detection), and D6124 (Residual Powder).
🧪 Material Composition and Sampling Protocol
The material requirements allow the use of any nitrile rubber polymer compound that permits the finished glove to meet all specified performance requirements. Strict regulations govern surface treatments to ensure patient and user safety. Any applied lubricant must meet the current requirements of the U.S. Pharmacopeia for absorbable dusting powder, or its safety and efficacy must be independently established. Talc is explicitly prohibited on both the inside and outside surfaces of all gloves covered by this specification.
For referee testing, sampling must be conducted on the finished product after sterilization when labeled sterile. Sampling and inspection must be performed in accordance with ISO 2859, employing the inspection levels and Acceptable Quality Levels (AQL) specified in Table 1 of the standard, or as agreed upon between the purchaser and the seller.
| 🔍 Aspect | 📋 Specification Details |
|---|---|
| Base Polymer | Nitrile rubber compound |
| Surface Finish | Talc prohibited. USP Lubricant permitted. |
| Glove Styles Covered | Single-use, ambidextrous, paired, sized, sterile, non-sterile |
| Referee Sampling | ISO 2859 (Inspection by Attributes) |
🛡️ Performance Requirements and Testing Methodologies
To ensure product integrity and user safety, the standard outlines three primary referee performance criteria. Verification relies on specific ASTM test methods and clearly defined inspection protocols. The specification acts as a referee procedure for evaluating performance but does not dictate the safe and proper clinical use of the gloves.
✅ Conformance Note: Gloves must be free from holes, have consistent physical dimensions, and meet sterility requirements if labeled sterile. The referee testing protocols ensure a standardized evaluation against these criteria.
Gloves labeled as sterile must comply with the sterility requirements detailed in Section 7.2. All gloves, regardless of labeling, must meet the freedom from holes requirement using the water leak test outlined in ASTM D5151. Finally, physical dimensions—including length, width, and thickness—must conform to the requirements of Section 7.4 and be verified using the principles of ASTM D3767.
| 🎯 Performance Criteria | ⚡ Applicable Test Method | 📌 Key Compliance Indicator |
|---|---|---|
Sterility (if
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