Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-147: ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. (General Plastic Surgery/General Hospital)
Date of Standard: 2005. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Medical gloves (examination and surgeon's gloves) |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.4460 |
Surgeon'S Gloves |
Class 1 |
KGO |
| |
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 |
| |
|
| Relevant Guidance: |
| Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |
|
| FDA Technical Contact: |
| Terrell Cunningham |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2502 |
| Silver Spring MD 20993 |
| 301/796-6299 |
| Email: terrell.cunningham@fda.hhs.gov |
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