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D6124-06 – Standard Test Method Technical Guide
🧪 Overview of Test Methodologies
The standard defines two distinct procedures tailored to the glove type. Procedure I is intended for gloves labeled as non-powdered, powder-free, powderless, or equivalent terminology. Procedure II is designed for powdered gloves, where the filter-retained mass comprises manufacturing residues, former release agents, and donning powder. The average mass per glove is reported in milligrams (mg).
Significance and Use (Section 4): This test method serves as a reference for evaluating samples of medical gloves. The results offer a quantitative measure of water-insoluble residues remaining after manufacturing.
| 📏 Parameter | 🧪 Procedure I (Powder-Free) | ⚗️ Procedure II (Powdered) |
|---|---|---|
| Target Glove Type | Non-powdered, powder-free | Powdered gloves |
| Filter-Retained Mass Composition | Residual manufacturing powder | Residue + release agent + donning powder |
| Application | Verification of low-residue claims | Quantification of total donning powder |
⚙️ Apparatus and Precision Requirements
Section 5 mandates a critical apparatus for this test: an Analytical Balance with a readability and repeatability of 0.1 mg. This high degree of precision is necessary to accurately weigh the small quantities of residual powder extracted from the glove samples.
The standard references ASTM D4483 for evaluating the precision of the test method and ANSI/ASQC Z1.9-1993 for sampling procedures and tables for inspection by variables. The values stated in SI units are regarded as the standard.
💡 Technical Tip: When conducting this test, ensure the analytical balance is properly calibrated and placed in a vibration-free, temperature-controlled environment to achieve the required 0.1 mg readability. The use of anti-static measures may be necessary to avoid erroneous weight readings from electrostatic charges on the filter media.
📊 Data Reporting and Standard Compliance
The final result is reported as the average powder mass per glove in milligrams. This value is crucial for regulatory compliance and product specification verification. The standard was reapproved in 2022, ensuring it reflects current industry practices and precision requirements. The safe and proper use of medical gloves is explicitly beyond the scope of this test method (Section 1.3).
| 🔍 Element | 📌 Definition per D6124-06 |
|---|---|
| Scope | Average powder or filter-retained mass on medical gloves. |
| Reporting Units | Milligrams (mg) per glove. |
| “Powder” Defined (3.1.2) | Any water insoluble, filter-retained residue. |
| Gloves Covered (3.1.1) | Both surgical and examination gloves. |
⚠️ Important Note: The standard explicitly states it does not address all safety concerns. Users are responsible for establishing appropriate safety, health, and environmental practices before use. The scope is strictly limited to the quantification of powder mass; it does not evaluate the safe use of the gloves themselves.
❓ Frequently Asked Questions
🔍 What is the difference between Procedure I and Procedure II?
Procedure I is used for gloves described as non-powdered or powder-free. Procedure II is used for powdered gloves, where the captured mass includes donning powder and other manufacturing residues.
💡 What specific apparatus is required for this test?
An analytical balance with a readability and repeatability of 0.1 mg is mandatory to ensure the accuracy of the residual powder weight measurements.
⚡ What units are used to report the residual powder mass?
The standard mandates that the average powder mass per glove is reported strictly in milligrams (mg), as SI units are regarded as the standard for this test method (Section 1.4).
📌 Does this standard apply to all types of medical gloves?
Yes, the terminology in the standard defines “medical gloves” as encompassing both surgical gloves and examination gloves (Section 3.1.1).