Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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9-88
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Standard | |
ISO 29942 First edition 2011-07-01 Prophylatic dams -- Requirements and test methods |
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Scope/AbstractISO 29942:2011 specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§884.5300 |
Barrier, Std, Oral Sex
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Class 2
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MSC
|
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Relevant FDA Guidance and/or Supportive Publications*
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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
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*These are provided as examples and others may be applicable. |