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510(k) Data Aggregation
K Number
K974121Device Name
LUBRICATED BAGGY TACTYLON CONDOM
Manufacturer
Date Cleared
1998-01-29
(90 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SENSICON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done. There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).
Device Description
The TACTYLON® condom is made from styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom.
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K Number
K971590Device Name
TACTYLON CONDOM
Manufacturer
Date Cleared
1997-10-07
(159 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SENSICON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - . The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done. - . There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).
Device Description
The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. The TACTYLON® condom is made from styrene-ethylene-butylene-styrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and dimensions that are substantially equivalent to a NRL condom.
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