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510(k) Data Aggregation
K Number
K210208Device Name
Titan Condoms
Manufacturer
Date Cleared
2022-02-17
(387 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Titan Condoms LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
Titan Condoms are made of a natural latex sheath which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and a cylinder shape. Titan condoms are available in a range of sizes, with different length and width combinations. Surface textures include smooth, dotted, and ribbed. Titan Condoms are provided prelubricated with a silicone-based lubricant.
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K Number
K970792Device Name
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE
Manufacturer
Date Cleared
1997-06-02
(90 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TITAN CONDOMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than required by the ASTM standard. The breakage rate during sex has not been tested."
Device Description
ExtraWear™, Gentlemen's Choice™, Extra Strength ... ... Non-Lubricated Latex Condom
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