| ASTM D3577-09 (Reapproved 2015) Standard Specification for Rubber Surgical Gloves |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 6-168 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Bifeng Qian FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-2261 bifeng.qian@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 specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 The following safety hazards caveat pertains only to the test method portion, Section 8, of this specification: 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.4460 | Surgeon'S Gloves | Class 1 | KGO |
| Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |