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FDA 510(k)

LATEX CONDOMS - CODE NO. 402, CODE NO. 1028

K-Number: K901668 · 1990-05-16

ApplicantAllercare/Nsl, Inc.
Decision Date1990-05-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 is the device name listed in this FDA 510(k) record. The listed applicant is Allercare/Nsl, Inc.. It received FDA 510(k) clearance on 1990-05-16 under 510(k) number K901668. 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 LATEX CONDOMS - CODE NO. 402, CODE NO. 1028?

LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 is a medical device that received FDA 510(k) clearance on 1990-05-16. The listed applicant is Allercare/Nsl, Inc.. The 510(k) number is K901668.

When did LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 receive FDA 510(k) clearance?

LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 received FDA 510(k) clearance on 1990-05-16, under 510(k) number K901668.

Who is the listed applicant for LATEX CONDOMS - CODE NO. 402, CODE NO. 1028?

The FDA 510(k) record lists Allercare/Nsl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX CONDOMS - CODE NO. 402, CODE NO. 1028?

The FDA product code for LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 is HIS.

Related Clinical Trials

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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Other records listing Allercare/Nsl, Inc. 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.

K901696LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033K901667LATEX CONDOMS - CODE NO. 401, 421 & 1002K901669LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000

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

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

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