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D5250-19 – Standard Test Method Technical Guide
📜 Scope and Material Requirements
ASTM D5250-19 (Reapproved 2023) defines the specification for poly(vinyl chloride) (PVC) gloves intended for use in medical examinations, diagnostic and therapeutic procedures, and the handling of contaminated medical materials. This standard functions as a referee procedure for evaluating the performance and safety of these medical barrier devices, covering gloves that fit either hand (ambidextrous), paired gloves, and individual sizes. The specification provides for packaged sterile, packaged nonsterile, and bulk nonsterile glove configurations.
The standard explicitly excludes two-dimensional heat sealed PVC gloves. Any PVC polymer compound may be used provided the finished glove meets the specified performance requirements. A critical material restriction is the complete prohibition of talc on all glove surfaces. Any lubricant applied must meet the current U.S. Pharmacopeia (USP) requirements for absorbable dusting powder, or its safety and efficacy must be previously established through rigorous validation.
⚠️ Talc Prohibition: ASTM D5250 explicitly mandates that both the inside and outside surfaces of poly(vinyl chloride) examination gloves shall be completely free of talc. This requirement ensures that traditional talc-based powders are not used as mold-release agents or lubricants in the manufacturing of these medical gloves.
⚙️ Performance Requirements and Sampling Protocols
For referee purposes, gloves must be sampled from the finished product after sterilization, following the inspection procedures of ISO 2859. The specific inspection levels and acceptable quality levels (AQL) must conform to those detailed in Table 1 of the standard, or as agreed upon between the purchaser and seller for a more comprehensive evaluation. This ensures uniform and statistically valid quality assessment across production lots.
| 🟦 Requirement | 📏 Referee Test Method | 🎯 Acceptance Criteria |
|---|---|---|
| Freedom from Holes | D5151 – Detection of Holes in Medical Gloves | Conforms to specified AQL (Table 1) |
| Physical Dimensions | D3767 – Measurement of Dimensions | Complies with specified size tolerances |
| Sterility (Packaged Sterile) | Section 7.2 | No microbial growth detected |
| Residual Lubricant Powder | D6124 – Residual Powder on Medical Gloves | Meets current USP requirements |
| Tensile Strength & Elongation | D412 – Tension Testing of Elastomers | Meets specified minimum values |
💡 Referee Sampling Strategy: The AQL for pinholes is a critical safety metric for medical gloves. The levels specified in Table 1 of D5250 are designed to ensure that the batch inspection provides a statistically high degree of confidence in barrier integrity for clinical and diagnostic medical applications.
📊 Material Conditioning and Integrity Testing
To ensure long-term reliability and storage stability, the PVC material must maintain adequate barrier properties over time. The standard references Test Method D573 (Rubber—Deterioration in an Air Oven) for accelerated aging evaluations, validating that the glove material maintains its tensile properties and elongation throughout its intended shelf life. Tensile testing per D412 ensures the film strength is adequate for rigorous donning and barrier protection during medical procedures.
The specification also recognizes that the safe and proper use of poly(vinyl chloride) examination gloves—including donning techniques, chemical resistance, and application-specific risks—is beyond the scope of this material-focused referee standard. This distinction ensures the testing requirements remain strictly focused on reproducible material and manufacturing quality metrics.
❓ Frequently Asked Questions
🔍 What types of PVC gloves are excluded from this standard?
Standard D5250 explicitly excludes two-dimensional heat sealed poly(vinyl chloride) gloves from its scope. It is intended exclusively for formed, three-dimensional gloves used in medical examinations and procedures.
💡 Can non-USP lubricants be applied to the gloves?
Yes, provided the safety and efficacy of the lubricant have been previously established and validated. If this is not the case, the lubricant must comply with the current U.S. Pharmacopeia (USP) requirements for absorbable dusting powder.
⚡ What is the significance of the 2023 reapproval (D5250-19R23)?
The 2023 reapproval indicates that ASTM International has reviewed the standard and confirmed it remains current. It reflects stable industry technology and market requirements without the need for substantial technical revisions since the 2019 edition.
📌 How does D5250 relate to D3578 (Rubber Examination Gloves)?
This specification is directly similar in structure and intent to Specification D3578 but applies specifically to poly(vinyl chloride) gloves rather than rubber gloves. Both standards serve as referee procedures for evaluating the performance of medical examination gloves based on their distinct polymer bases.