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FDA 510(k)

MALE CONDOM

K-Number: K822088 · 1982-11-03

ApplicantSchmid Laboratories, Inc.
Decision Date1982-11-03
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MALE CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Schmid Laboratories, Inc.. It received FDA 510(k) clearance on 1982-11-03 under 510(k) number K822088. 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 MALE CONDOM?

MALE CONDOM is a medical device that received FDA 510(k) clearance on 1982-11-03. The listed applicant is Schmid Laboratories, Inc.. The 510(k) number is K822088.

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

MALE CONDOM received FDA 510(k) clearance on 1982-11-03, under 510(k) number K822088.

Who is the listed applicant for MALE CONDOM?

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

What is the FDA product code for MALE CONDOM?

The FDA product code for MALE CONDOM is HIS.

Related Clinical Trials

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Related PubMed Literature

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.

PMID: 30272398Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order.Federal register ()

Other records listing Schmid Laboratories, 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.

K897140THIN CONDOM RAMSES & SHEIKK900679MINT SCENTED CONDOMSK884399STANDARD LATEX CONDOMK882893CONDOMS (RAMSES, SHEIK AND KOROMEX)K880820OKAMOTO CONDOMS SPERMICIDALLY LUBRICATEDK874791CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)

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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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