Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-34: ISO 4074 First edition 2002-02-15/ ISO 4074:2002, TECHNICAL CORRIGENDUM 1 Natural latex rubber condoms - Requirements and test methods, Technical Corrigendum 1. (ObGyn/Gastroenterology)
Date of Standard: 2002. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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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 |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard with the following exceptions:
Section 6 (Burst Volume and Pressure) and Section 8 (Freedom from Holes)
FDA's recognition of these two sections 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.
Section 11.2.1 (Symbols) FDA does not recognize the symbol requirements of ISO 15223 and EN 980.
NOTE: General labeling requirements are given in 21 CFR 801.
NOTE: The labeling requirement 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 hang-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 |
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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 Notificiations: 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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