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Found 20 results
510(k) Data Aggregation
K Number
K243967Device Name
ONE Nitrile Condom
Manufacturer
Global Protection Corp.
Date Cleared
2025-04-08
(106 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
Device Description
Not Found
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K Number
K241617Device Name
Durex Polyisoprene Condom
Manufacturer
RB Health (US) LLC
Date Cleared
2025-02-28
(268 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Durex Polyisoprene Condom is used for contraception and for prophylactic purposes (to help regnancy and the transmission of sexually transmitted infections, STIs).
Device Description
Not Found
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K Number
K240379Device Name
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Manufacturer
Church & Dwight Co., Inc.
Date Cleared
2024-10-08
(244 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).
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K Number
K240896Device Name
ONE Nitrile Condom
Manufacturer
Global Protection Corp.
Date Cleared
2024-08-23
(144 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
Device Description
Not Found
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K Number
K232470Device Name
Polyisoprene Extra Large Condom
Manufacturer
Suretex Limited
Date Cleared
2024-05-09
(267 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).
Device Description
The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.
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K Number
K231908Device Name
45 Micron Polyisoprene Condom
Manufacturer
Suretex Limited
Date Cleared
2023-10-27
(120 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
Device Description
The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
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K Number
K203541Device Name
Okamoto 002 Lubricated Polyurethane Male Condom
Manufacturer
Okamoto U.S.A. Inc.
Date Cleared
2022-02-25
(449 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Device Description
This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.
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K Number
K182438Device Name
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
Manufacturer
Sxwell Usa LLC
Date Cleared
2018-12-06
(90 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
Device Description
The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.
The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
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K Number
K171172Device Name
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Manufacturer
Ansell Healthcare Products LLC.
Date Cleared
2017-08-02
(103 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
Device Description
The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
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K Number
K171639Device Name
Trojan Supra Lubricated Polyurethane Male Condom
Manufacturer
Church & Dwight Co., Inc.
Date Cleared
2017-08-01
(60 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Product Code :
MOL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
Device Description
The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
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