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510(k) Data Aggregation
K Number
K192669Device Name
Extremely Thin 003, ZERO ZERO THREE
Manufacturer
Okamoto U.S.A., Inc.
Date Cleared
2020-07-24
(303 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Okamoto U.S.A., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Device Description
The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.
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K Number
K141256Device Name
OKAMOTO STUDDED CONDOM
Manufacturer
OKAMOTO U.S.A., INC.
Date Cleared
2014-07-23
(70 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
OKAMOTO U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008. The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039).
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K Number
K140379Device Name
MEGA BIG BOY CONDOM
Manufacturer
OKAMOTO U.S.A., INC.
Date Cleared
2014-07-01
(137 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
OKAMOTO U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/ADS and the transmission of sexually transmitted infections).
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is smooth surface, flared at the closed end with reservoir tip, silicone lubricated condom with nominal length 200 mm, nominal flat width 57 mm, and nominal thickness of 0.065 mm. The air burst pressure is > 1 kPa and air burst volume is > 19 dm3. It is lubricated with silicone (viscosity 350 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008.
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K Number
K090259Device Name
OKAMOTO ULTRA THIN
Manufacturer
OKAMOTO U.S.A., INC.
Date Cleared
2009-03-31
(57 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
OKAMOTO U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.
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