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510(k) Data Aggregation
K Number
K181844Device Name
One Touch
Manufacturer
Date Cleared
2019-04-15
(278 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 and ISO 4074:2015.
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