| ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-147 |
| 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 practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.
1.2 It is emphad that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials.
| 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 |
| §878.4460 | Surgeon'S Gloves | Class 1 | KGO |
| Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |