ASTM D6124-06 (2022) PDF

Full title and description

ASTM D6124-06(2022) — Standard Test Method for Residual Powder on Medical Gloves. This test method provides laboratory procedures to determine the amount of residual powder and other filter‑retained solids found on medical examination and surgical gloves; it is intended as a reference method for evaluation of glove samples.

Abstract

This standard defines two complementary test procedures to quantify particulate residue associated with medical gloves: Procedure I for quantitation on gloves described as powder‑free (non‑powdered) and Procedure II for quantitation of powder and other filter‑retained mass on powdered gloves. Results are reported as average powder (or filter‑retained) mass per glove in milligrams. The method specifies sample selection, rinsing/agitation, filtration (where applicable), drying/desiccation and gravimetric determination.

General information

• Status: Active (reapproved/revised in 2022; current designation D6124-06(2022)).
• Publication date: 1 June 2022 (revised edition).
• Publisher: ASTM International (American Society for Testing and Materials).
• ICS / categories: 11.140 (Hospital equipment) — medical/healthcare protective gloves and related test methods.
• Edition / version: D6124‑06(2022) (revision of earlier D6124 versions; shown as D6124‑06R22 on some listings).
• Number of pages: 5 pages.

Scope

The standard covers the determination of the average powder or filter‑retained mass found on samples of medical gloves. It specifies that results are reported in milligrams per glove, clarifies that safe and proper clinical use of gloves is outside the method's scope, and states that SI units are the standard for reporting. The method is suitable as a laboratory reference for powdered and powder‑free gloves alike.

Key topics and requirements

• Two procedures: Procedure I — quantitation for gloves described as powder‑free (measures non‑powder solids and low residuals); Procedure II — quantitation for powdered gloves (filter and weigh powdered residue).
• Sample selection and replication: defined random selection and number of gloves per lot for testing (typical small replicate sample sets per lot).
• Wet‑rinse/agitation steps: specified rinsing of glove interior/exterior with deionized or distilled water and controlled mechanical agitation to dislodge residues.
• Filtration and gravimetric measurement: for powdered gloves a specified glass microfiber filter (nominal 90 mm, ~2.7 μm) and desiccation/pre‑weighing are required before and after sample filtration to determine mass retained.
• Reporting: average powder mass per glove reported in milligrams; method notes that measured mass for powdered gloves may include water‑insoluble residues, former release agents and donning powders.
• Units and safety: SI units are the basis; users must observe general laboratory safety and determine any regulatory or safety limitations for use of results.

Typical use and users

Used by glove manufacturers for quality control and lot release testing, by third‑party testing laboratories performing conformance or comparative testing, and by regulatory/health‑care procurement and product evaluation groups assessing residual powder content on medical gloves. The method is applicable both in product development and routine verification contexts.

Related standards

ASTM D6124 is often used in conjunction with other glove performance and specification standards (for example, standards addressing physical properties, barrier performance and material composition). It is part of the committee D11 (rubber and rubber‑like materials) portfolio and is sometimes referenced in product specifications and regulatory guidance covering medical examination and surgical gloves.

Keywords

residual powder, medical gloves, powdered gloves, powder‑free gloves, filtration, gravimetric, Procedure I, Procedure II, mg per glove, ASTM D6124.

FAQ

Q: What is this standard?

A: ASTM D6124‑06(2022) is a test method that specifies laboratory procedures to quantify residual powder and other filter‑retained solids on medical gloves and to report average powder mass per glove in milligrams.

Q: What does it cover?

A: It covers sample selection, rinsing/agitation, filtration (when applicable), pre‑ and post‑weighing of filters or rinse residues, calculation of average mass per glove, and reporting conventions. It includes two procedures tailored to powder‑free and powdered gloves respectively.

Q: Who typically uses it?

A: Glove manufacturers, independent testing laboratories, quality assurance teams, procurement/specification writers in healthcare, and regulatory or conformity assessment bodies use this standard when evaluating or specifying residual powder levels on medical gloves.

Q: Is it current or superseded?

A: The document is the revised 2022 edition (designation D6124‑06(2022)) and is listed as the active/revised standard as of its June 1, 2022 publication; it updates earlier versions of D6124. Users should confirm the publisher's catalog for any more recent revisions.

Q: Is it part of a series?

A: D6124 is part of ASTM Committee D11 (rubber and rubber‑like materials) and belongs to the set of test methods and specifications addressing medical gloves and related rubber products; it is commonly used alongside other ASTM glove standards.

Q: What are the key keywords?

A: Residual powder, powder‑free, powdered gloves, filter‑retained mass, gravimetric, Procedure I, Procedure II, milligrams per glove.