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FDA 510(k)

STANDARD CONDOM

K-Number: K895530 · 1989-11-28

ApplicantMayer Laboratories
Decision Date1989-11-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STANDARD CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1989-11-28 under 510(k) number K895530. 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 STANDARD CONDOM?

STANDARD CONDOM is a medical device that received FDA 510(k) clearance on 1989-11-28. The listed applicant is Mayer Laboratories. The 510(k) number is K895530.

When did STANDARD CONDOM receive FDA 510(k) clearance?

STANDARD CONDOM received FDA 510(k) clearance on 1989-11-28, under 510(k) number K895530.

Who is the listed applicant for STANDARD CONDOM?

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

What is the FDA product code for STANDARD CONDOM?

The FDA product code for STANDARD CONDOM is HIS.

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Other records listing Mayer Laboratories 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.

K252158Sagami Original 002 Polyurethane Male CondomK001974EZ-ON CONDOMK946374KIMONO MICROTHINK943064KIMONO (CONDOMS)K946376MAXXK925869SHEATHES, STERILE SHEATHES

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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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