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FDA 510(k)

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

K-Number: K010178 · 2001-04-27

ApplicantInnolatex Sdn. Bhd
Decision Date2001-04-27
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERMICIDAL LUBRICATED MALE LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Innolatex Sdn. Bhd. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010178. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPERMICIDAL LUBRICATED MALE LATEX CONDOM?

SPERMICIDAL LUBRICATED MALE LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Innolatex Sdn. Bhd. The 510(k) number is K010178.

When did SPERMICIDAL LUBRICATED MALE LATEX CONDOM receive FDA 510(k) clearance?

SPERMICIDAL LUBRICATED MALE LATEX CONDOM received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010178.

Who is the listed applicant for SPERMICIDAL LUBRICATED MALE LATEX CONDOM?

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

What is the FDA product code for SPERMICIDAL LUBRICATED MALE LATEX CONDOM?

The FDA product code for SPERMICIDAL LUBRICATED MALE LATEX CONDOM is LTZ.

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 Innolatex Sdn. Bhd 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.

K053367MALE NATURAL RUBBER LATEX CONDOMK041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDK012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANTK01296456MM CONDOM,MALE NATURAL RUBBER LATEX CONDOMK012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOMK012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT

View all 9 devices →

Related Devices (Code: LTZ)

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.K992438INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)Indus Medicare , Ltd.

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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