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510(k) Data Aggregation
K Number
K992081Device Name
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
Manufacturer
SURETEX PROPHYLACTICS (INDIA) LTD.
Date Cleared
1999-08-19
(59 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SURETEX PROPHYLACTICS (INDIA) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
Device Description
This condom is a male contraceptive and prophylactic device which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. This condom is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600.
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K Number
K983320Device Name
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
Manufacturer
SURETEX PROPHYLACTICS (INDIA) LTD.
Date Cleared
1998-12-11
(81 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SURETEX PROPHYLACTICS (INDIA) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).
Device Description
A condom with silicone lubricant is a sheath which covers the penis with a closely fitted membrane
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K Number
K981621Device Name
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
Manufacturer
SURETEX PROPHYLACTICS (INDIA) LTD.
Date Cleared
1998-06-19
(44 days)
Product Code
LTZ
Regulation Number
884.5310Why did this record match?
Applicant Name (Manufacturer) :
SURETEX PROPHYLACTICS (INDIA) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).
Device Description
A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.
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