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FDA 510(k)

One Touch Spiral Condom

K-Number: K210294 · 2021-09-23

ApplicantThai Nippon Rubber Industry Public Company Limited.
Decision Date2021-09-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

One Touch Spiral Condom is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K210294. 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 One Touch Spiral Condom?

One Touch Spiral Condom is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K210294.

When did One Touch Spiral Condom receive FDA 510(k) clearance?

One Touch Spiral Condom received FDA 510(k) clearance on 2021-09-23, under 510(k) number K210294.

Who is the listed applicant for One Touch Spiral Condom?

The FDA 510(k) record lists Thai Nippon Rubber Industry Public Company Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Touch Spiral Condom?

The FDA product code for One Touch Spiral Condom is HIS.

Other records listing Thai Nippon Rubber Industry Public Company 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.

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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.

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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