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510(k) Data Aggregation
K Number
K243584Device Name
0.04 ZERO ZERO FOUR Male Latex Condom
Manufacturer
Okamoto USA, Inc.
Date Cleared
2025-02-18
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Okamoto USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.
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