Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-175: ASTM D 5151 -06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves. (General Plastic Surgery/General Hospital)
Date of Standard: 2006. |
| 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: |
| Surgical and Examination Gloves |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
|
| 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 |
Polymer Patient Examination Glove |
Class 1 |
LZA |
| §880.6250 |
Vinyl Patient Examination Glove |
Class 1 |
LYZ |
| |
|
| Relevant Guidance: |
| Guidance for 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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