Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-244: ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. (General Plastic Surgery/General Hospital)
Date of Standard: 2010. |
| 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: |
| Rubber Examination Gloves |
|
| Processes Affected: |
| 510(k), PMA, IDE, PreIDE, HDE |
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| 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 |
| §880.6250 |
Polymer Patient Examination Glove |
Class 1 |
LZA |
| |
|
| Relevant Guidance: |
| Guidance for Industry and FDA Staff-Medical Glove Guidance Manual. Issued January 22, 2008 |
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| FDA Technical Contact: |
| Donna L. Walsh |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2126 |
| Silver Spring MD 20993 |
| 301/796-2498 |
| Email: donna.walsh@fda.hhs.gov |
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