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510(k) Data Aggregation
K Number
K220273Device Name
Onetouch Non-paraben Lubricant Gel
Manufacturer
Thai Nippon Rubber Industry Public Company Limited.
Date Cleared
2022-10-21
(263 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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
Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is intended for penile, vaginal and/or anal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions:
- 1. Natural Color, No Flavor
- 2. Natural Color, Cucumber Flavor
- 3. Natural Color, Mixfruit Flavor
- Pink Color, Strawberry Flavor 4.
- 5. Natural Color, Strawberry Flavor
- 6. Natural Color, Vanilla Flavor
- 7. Natural Color, Mentha Piperita (Peppermint) Flavor
- Natural Color, Aloe Vera Flavor 8.
The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above.
Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.
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K Number
K210095Device Name
Playboy Premium Silicone Lubricant
Manufacturer
Thai Nippon Rubber Industry Public Company Limited
Date Cleared
2021-11-23
(313 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal 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
Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.
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K Number
K211450Device Name
Playboy 3 Contour Condom
Manufacturer
Thai Nippon Rubber Industry Public Company Limited
Date Cleared
2021-09-30
(143 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Playboy 3 Contour Condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Device Description
Not Found
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K Number
K210294Device Name
One Touch Spiral Condom
Manufacturer
Thai Nippon Rubber Industry Public Company Limited
Date Cleared
2021-09-23
(233 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
Not Found
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K Number
K171213Device Name
One Touch Condom with Benzocaine
Manufacturer
Thai Nippon Rubber Industry Public Company Limited
Date Cleared
2018-01-12
(262 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Thai Nippon Rubber Industry Public Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
for the indications for use stated in the enclosure
Device Description
Not Found
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