Recognized standard
D6124-06(2022)
FDA recognition 6-178 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-178 |
|---|---|
| Designation | D6124-06(2022) |
| Title | Standard Test Method for Residual Powder on Medical Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This test method covers the determination of average powder or filter-retained mass found on a sample of medical gloves as described in the introduction. 1.2 The average powder mass per glove is reported in milligrams. 1.3 The safe and proper use of medical gloves is beyond the scope of this… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: