Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-56: ASTM D3492-08, Standard Specification for Rubber Contraceptives (Male Condoms). (ObGyn/Gastroenterology)
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: |
| Latex Condoms and Latex Condoms with Spermicidal Lubricant |
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| Processes Affected: |
| 510(k), Design Control Input, Surveillance testing (water leakage) |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete Standard with the following exception:
Section 4 (Requirements)
FDA's recognition of this section applies only to condoms whose nominal dimensions fall within the following limits:
- condom lay-flat width is less than 54 mm
- condom length is greater than 160 mm
Condoms whose dimensions fall outside this dimensional envelope will be carefully evaluated with respect to potential impact on clinical performance (i.e., slip and break during actual use), as well as with respect to potential impact on key condom tests, e.g., airburst properties and freedom from holes. FDA will also carefully evaluate any condom whose nominal width exceeds 58 mm.
NOTE: General labeling requirements are given in 21 CFR 801.
NOTE: The labeling requirements for condom expiration date, including accelerated and real-time testing, is given in 21 CFR 801.435.
NOTE: FDA referee testing for water leakage (freedom from holes) is intended to follow the current FDA Compliance Policy Guide, sec. 345.100 Condoms: Defects - Criteria for Direct Reference Seizure (CPG 7124.21) and methodology comparable to the hand-and-roll method described in Annex L of ISO 4074:2002/Cor.2:2008(E) Natural latex rubber condoms - requirements and test methods, Technical Corrigendum 2. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5300 |
Condom |
Class 2 |
HIS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §884.5310 |
Condom With Nonoxynol-9 |
Class 2 |
LTZ |
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| Relevant Guidance: |
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 Condoms; Defects - Criteria for Direct Reference Seizure (CPG 7124.21) Revised March 1995.
Guidance for Industry and FDA Staff Surveillance and Detention without Physical Examination of Condoms Document issued on: July 11, 2008
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300. Document issued December 23, 2008
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide Document issued on: January 5, 2009 |
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| FDA Technical Contacts: |
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| Sharon Andrews |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G110 |
| Silver Spring MD 20993 |
| 301/796-6529 |
| Email: sharon.andrews@fda.hhs.gov |
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