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510(k) Data Aggregation
K Number
K142790Device Name
OneTouch Lubricant Gel
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2015-07-30
(307 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.
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K Number
K081265Device Name
THAI NIPPON MALE LATEX CONDOM
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2009-10-16
(529 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thai Nippon Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.
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K Number
K032909Device Name
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2003-12-16
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011253Device Name
FLAVORED MALE LATEX CONDOM
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2001-07-20
(87 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001978Device Name
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2000-08-08
(40 days)
Product Code
LTZ
Regulation Number
884.5310Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994095Device Name
LATEX CONDOM
Manufacturer
THAI NIPPON RUBBER INDUSTRY CO., LTD.
Date Cleared
2000-01-18
(46 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
THAI NIPPON RUBBER INDUSTRY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and 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-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.
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