| ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 6-355 |
| 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 the requirements for finger cots used in industrial applications which are made from natural rubber latex or a synthetic nitrile polymer. The purpose of this specification is to obtain consistent performance among products produced in various locations or at various times in the same location.
1.2 This specification does not cover the safe and proper use of finger cots or products of special construction for special use.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6250 | Finger Cot | Class 1 | LZB |
| Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |