Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-214: ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. (General Plastic Surgery/General Hospital)
Date of Standard: 2007. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Medical gloves and condoms made from natural rubber latex |
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| Processes Affected: |
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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 |
| §878.4460 |
Surgeon'S Gloves |
Class 1 |
KGO |
| |
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 |
Patient Examination Glove, Specialty |
Class 1 |
LZC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5300 |
Condom |
Class 2 |
HIS |
| |
|
| Relevant Guidance: |
Guidance for Industry and FDA Staff - Medical Glove Guidance Manual. Issued January 22, 2008
Latex Condoms for Men - Information for 510(k) Premarket Notification: Use of Consensus Standards for Abbreviated Submissions (July 23, 1998)
Compliance Policy Guide and FDA Test Methods (Sub Chapter 345 Obstetrics and Gynecology (Sec. 345.100 (CPG 7124.21)) |
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| FDA Technical Contact: |
| Anne D. Lucas |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 64, Room 4010 |
| Silver Spring MD 20993 |
| 301/796-0283 |
| Email: anne.lucas@fda.hhs.gov |
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