| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
9-111
|
| Standard | |
ISO 4074 Third edition 2015-10-15
Natural latex rubber condoms - Requirements and test methods |
|
Scope/Abstract| ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §884.5300 |
Condom
|
Class 2
|
HIS
|
| §884.5310 |
Condom With Nonoxynol-9
|
Class 2
|
LTZ
|
| 21 CFR 801.435, User labeling for latex condoms |
|
Relevant FDA Guidance and/or Supportive Publications*
Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions, Issued July 1998.
Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms, Issued July 2008.
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300, Issued December 2008.
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide, Issued January 2009.
Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
|
| *These are provided as examples and others may be applicable. |
