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FDA 510(k)

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT

K-Number: K822792 · 1982-09-30

ApplicantAnsell, Inc.
Decision Date1982-09-30
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822792. 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 NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT?

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Ansell, Inc.. The 510(k) number is K822792.

When did NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT receive FDA 510(k) clearance?

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822792.

Who is the listed applicant for NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT?

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

What is the FDA product code for NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT?

The FDA product code for NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT is HIS.

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Other records listing Ansell, 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.

K984392ANSELL CONDOMSK983518LIFESTYLES XTRA PLEASUREK940047SPERMICIDALLY LUBRICATED CONDOMK953379HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVEK945766HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVESK945767POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES

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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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