| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 6-145 |
| 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 natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.
1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6250 | Latex Patient Examination Glove | Class 1 | LYY |
| §880.6250 | Polymer Patient Examination Glove | Class 1 | LZA |
| §880.6250 | Vinyl Patient Examination Glove | Class 1 | LYZ |
| Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |