| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 6-178 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Katharine Segars FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-2780 Katharine.Segars@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 test method.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6250 | Polymer Patient Examination Glove | Class 1 | LZA |
| §880.6250 | Vinyl Patient Examination Glove | Class 1 | LYZ |
| §878.4460 | Surgeon'S Gloves | Class 1 | KGO |
| Guidance for Industry and FDA - Medical Glove Guidance Manual. Issued January 2008. |