| ASTM D5250-06 (Reapproved 2015) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 6-183 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | John Stansberry FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-8915 John.Stansberry@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 poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material.
1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves.
1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves.
1.4 This specification is similar to that of Specification D3578 for rubber examination gloves.
| 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 |
| Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008. Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff, Issued December 2, 2014. |