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FDA 510(k)

Microthin Natural Rubber Latex Condom

K-Number: K213921 · 2022-04-28

ApplicantSuretex Limited
Decision Date2022-04-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Microthin Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Suretex Limited. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K213921. 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 Microthin Natural Rubber Latex Condom?

Microthin Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Suretex Limited. The 510(k) number is K213921.

When did Microthin Natural Rubber Latex Condom receive FDA 510(k) clearance?

Microthin Natural Rubber Latex Condom received FDA 510(k) clearance on 2022-04-28, under 510(k) number K213921.

Who is the listed applicant for Microthin Natural Rubber Latex Condom?

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

What is the FDA product code for Microthin Natural Rubber Latex Condom?

The FDA product code for Microthin Natural Rubber Latex Condom 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.

NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

Other records listing Suretex Limited 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.

K252521LifeStyles® HydraFeel Natural Rubber Latex CondomK232470Polyisoprene Extra Large CondomK23190845 Micron Polyisoprene CondomK232279LifeStyles NRL Textured CondomK221243OFNat Lubricant (L15)

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.

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.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, 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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