Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-176: ASTM D7103-06 (E 2010), Standard Guide for Assessment of 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 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete Standard; however, exclude Section 10 of the standard, "Assessment of Resistance to Viral Penetration". FDA does not clear for market any labeling claims related to F1671. |
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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 |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6250 |
Finger Cot |
Class 1 |
LZB |
| §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 |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008 |
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| 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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