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FDA 510(k)

DUREX SYNTHETIC POLYISOPRENE MALE CONDOM

K-Number: K072169 · 2008-06-19

ApplicantSsl Americas, Inc.
Decision Date2008-06-19
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUREX SYNTHETIC POLYISOPRENE MALE CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Ssl Americas, Inc.. It received FDA 510(k) clearance on 2008-06-19 under 510(k) number K072169. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUREX SYNTHETIC POLYISOPRENE MALE CONDOM?

DUREX SYNTHETIC POLYISOPRENE MALE CONDOM is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is Ssl Americas, Inc.. The 510(k) number is K072169.

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

DUREX SYNTHETIC POLYISOPRENE MALE CONDOM received FDA 510(k) clearance on 2008-06-19, under 510(k) number K072169.

Who is the listed applicant for DUREX SYNTHETIC POLYISOPRENE MALE CONDOM?

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

What is the FDA product code for DUREX SYNTHETIC POLYISOPRENE MALE CONDOM?

The FDA product code for DUREX SYNTHETIC POLYISOPRENE MALE CONDOM is MOL.

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Other records listing Ssl Americas, 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.

K063385DUREX PLAY MASSAGE GEL LUBRICANTK060098DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTSK042958DUREX PLAY TINGLING LUBRICANTK042470DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOMK042563DUREX PLAY WARMER LUBRICANTK032227DUREX FLAVORED LATEX CONDOM

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Related Devices (Code: MOL)

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.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

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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