Overview
ISO 21171:2006 - Medical gloves - Determination of removable surface powder specifies laboratory methods to quantify readily removable, water‑insoluble powder on the surface of medical gloves. It defines three test procedures: Method A for powdered gloves and Methods B and C for powder‑free gloves (with Method C tailored for surgeon’s gloves). The standard describes sampling, apparatus, reagents and calculation procedures but does not prescribe safety limits or address safety issues related to glove powder. Applicability to non‑rubber medical gloves is not established.
Key topics and technical requirements
- Scope and definitions: Defines “powder” as the water‑insoluble material removed under test conditions and distinguishes powdered vs. powder‑free gloves.
- Sampling: Random selection; Method A uses two gloves, Method B uses five gloves, Method C uses three pairs (six gloves) for surgeon’s gloves.
- Test principle: Surfaces are washed with water to transfer removable powder to the rinse water; powder is collected by filtration, dried and weighed.
- Apparatus & critical parameters:
- Balance accuracy: 0.1 mg
- Mechanical shaker: minimum 1.7 Hz (102 cycles/min) for 30 s washes
- Drying oven: 100 °C ± 5 °C
- Filters: glass microfibre filters 2.7 µm pore size - 90 mm for Method A; 47 mm for Methods B/C
- Procedure highlights:
- Multiple rinses per glove (four rinses for Method A); pooled rinses for Methods B/C
- Blank determinations required for powder‑free procedures to account for background contamination
- Calculation formulas to report total and average powder mass per glove (mg)
- Quality elements: Clauses on precision and test reporting are included in the standard.
Applications and practical value
- Quality control and batch testing for medical glove manufacturers to verify product consistency and labelling (powdered vs. powder‑free).
- Independent testing laboratories performing routine or compliance testing using standardized, reproducible methods.
- Procurement, regulatory and hospital QA teams that require documented test results to support acceptance criteria, supplier evaluation or comparative assessments.
- Useful for research into glove manufacturing processes and for investigations where quantifying removable surface powder is needed.
Related standards
- ISO 21171:2006 is based on ASTM D6124‑01 (used with permission), and was prepared by ISO/TC 45 (Rubber and rubber products). The standard does not establish exposure/safety thresholds-users should consult relevant health and regulatory guidance for limits or risk assessment.
