Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-150: ASTM D7161-05 (Reapproved 2010), Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions. (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 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Surgical and Examination Gloves that have been manufactured for at least one year prior to the publication of ASTM D7160. |
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| Processes Affected: |
| 510(k), PMA, IDE, PreIDE, HDE |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard as an adjunct to ASTM Standard Practice D7160, for medical gloves that have been manufactured for at least one year prior to the publication of D7160.
CDRH anticipates that D7161 will become unnecessary within 5 years (the maximum shelf life currently allowed) as medical gloves that were not on the market prior to the publication of D7160 and that bear an expiration date will have expiration dates determined by the methods described in D7160. |
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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 |
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: |
| 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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