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FDA 510(k)

TROJAN EXTRA LARGE LATEX CONDOM

K-Number: K001212 · 2000-05-09

ApplicantArmkel, LLC
Decision Date2000-05-09
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN EXTRA LARGE LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K001212. 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 LARGE LATEX CONDOM?

TROJAN EXTRA LARGE LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Armkel, LLC. The 510(k) number is K001212.

When did TROJAN EXTRA LARGE LATEX CONDOM receive FDA 510(k) clearance?

TROJAN EXTRA LARGE LATEX CONDOM received FDA 510(k) clearance on 2000-05-09, under 510(k) number K001212.

Who is the listed applicant for TROJAN EXTRA LARGE LATEX CONDOM?

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

What is the FDA product code for TROJAN EXTRA LARGE LATEX CONDOM?

The FDA product code for TROJAN EXTRA LARGE LATEX CONDOM is HIS.

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Other records listing Armkel, LLC as applicant

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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.

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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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