| ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 6-401 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Elizabeth Claverie FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-6298 elizabeth.claverie@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 practice covers all surgeon"s and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life.
1.2 This standard does not purport to address all of the label claims and 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 |
| §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. |