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FDA 510(k)

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

K-Number: K001377 · 2000-06-08

ApplicantPleasure Latex Products Sdn. Bhd.
Decision Date2000-06-08
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 Pleasure Latex Products Sdn. Bhd.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K001377. 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 2000-06-08. The listed applicant is Pleasure Latex Products Sdn. Bhd.. The 510(k) number is K001377.

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

SPERMICIDAL LUBRICATED MALE LATEX CONDOM received FDA 510(k) clearance on 2000-06-08, under 510(k) number K001377.

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

The FDA 510(k) record lists Pleasure Latex Products 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 Pleasure Latex Products 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.

K022156LATEX ULTRASONIC PROBE COVERK023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOURK021875MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOMK020272MALE LATEX CONDOM WITH RIBBED SURFACEK002571MULITPLE MALE LATX CONDOMK001221MALE LATEX COMDOM WITH DOTTED SURFACE

View all 10 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.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.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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