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510(k) Data Aggregation
K Number
K050244Device Name
MALE NATURAL RUBBER LATEX CONDOM
Manufacturer
Date Cleared
2005-04-08
(65 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
NRS GLOBAL PARTNERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NRS Global Partners male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Device Description
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. This condom is identical to the predicate device with respect to design, physical properties, and formulation.
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