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FDA 510(k)

PROTEX CONTRACEPT PLUS W/SPERM-LUB

K-Number: K831816 · 1983-09-12

ApplicantNational Sanitary Laboratories, Inc.
Decision Date1983-09-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROTEX CONTRACEPT PLUS W/SPERM-LUB is the device name listed in this FDA 510(k) record. The listed applicant is National Sanitary Laboratories, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831816. 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 PROTEX CONTRACEPT PLUS W/SPERM-LUB?

PROTEX CONTRACEPT PLUS W/SPERM-LUB is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is National Sanitary Laboratories, Inc.. The 510(k) number is K831816.

When did PROTEX CONTRACEPT PLUS W/SPERM-LUB receive FDA 510(k) clearance?

PROTEX CONTRACEPT PLUS W/SPERM-LUB received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831816.

Who is the listed applicant for PROTEX CONTRACEPT PLUS W/SPERM-LUB?

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

What is the FDA product code for PROTEX CONTRACEPT PLUS W/SPERM-LUB?

The FDA product code for PROTEX CONTRACEPT PLUS W/SPERM-LUB 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 National Sanitary 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.

K842185PROTEX CONTRACEPT PLUS W/SPERM-LUB

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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