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510(k) Data Aggregation
K Number
K132107Device Name
MALE LATEX CONDOM
Manufacturer
NULATEX SDN. BHD.
Date Cleared
2014-03-07
(242 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
NULATEX SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nulatex Natural Male Latex Condom is used for contraception and prophylactic purposes. (To help prevent pregnancy and transmission of sexually transmitted infection)
Device Description
Not Found
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K Number
K121241Device Name
MALE LATEX CONDOM
Manufacturer
NULATEX SDN. BHD.
Date Cleared
2013-02-14
(295 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
NULATEX SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nulatex 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
Male Latex Condom. (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.
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K Number
K070937Device Name
MULTIPLE BRAND MALE LATEX CONDOM
Manufacturer
NULATEX SDN. BHD.
Date Cleared
2007-09-21
(170 days)
Product Code
HIS, LTZ
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
NULATEX SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
Not Found
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