Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Durex Penck Standard, Durex Penck XL

K-Number: K200672 · 2020-11-06

ApplicantRb Health (Us), LLC
Decision Date2020-11-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Durex Penck Standard, Durex Penck XL is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200672. 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 Durex Penck Standard, Durex Penck XL?

Durex Penck Standard, Durex Penck XL is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K200672.

When did Durex Penck Standard, Durex Penck XL receive FDA 510(k) clearance?

Durex Penck Standard, Durex Penck XL received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200672.

Who is the listed applicant for Durex Penck Standard, Durex Penck XL?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durex Penck Standard, Durex Penck XL?

The FDA product code for Durex Penck Standard, Durex Penck XL is HIS.

Other records listing Rb Health (Us), LLC 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.

K241617Durex Polyisoprene CondomK230781Belle SensilubeK213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineK220489Durex Patronus CloseFit, Durex Patronus RegularK222068Durex Penck III RegularK211152Durex Condom with Benzocaine

View all 15 devices →

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.

↑