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FDA 510(k)

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL

K-Number: K901197 · 1990-04-16

ApplicantCarter Products
Decision Date1990-04-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL is the device name listed in this FDA 510(k) record. The listed applicant is Carter Products. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K901197. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL?

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Carter Products. The 510(k) number is K901197.

When did TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL receive FDA 510(k) clearance?

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL received FDA 510(k) clearance on 1990-04-16, under 510(k) number K901197.

Who is the listed applicant for TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL?

The FDA 510(k) record lists Carter Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL?

The FDA product code for TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL is HIS.

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Other records listing Carter Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955672TROJAN POLYURETHANE CONDOM (MODIFICATION)K942697TROJAN POLYURETHANE CONDOMK912901TROJAN (TM-TBD) CONDOMK904782ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TESTK904273MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.K901202TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED

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Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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