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)

CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

K-Number: K003375 · 2001-01-28

ApplicantTecnilatex S.A.
Decision Date2001-01-28
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Tecnilatex S.A.. It received FDA 510(k) clearance on 2001-01-28 under 510(k) number K003375. 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 CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX?

CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX is a medical device that received FDA 510(k) clearance on 2001-01-28. The listed applicant is Tecnilatex S.A.. The 510(k) number is K003375.

When did CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX receive FDA 510(k) clearance?

CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX received FDA 510(k) clearance on 2001-01-28, under 510(k) number K003375.

Who is the listed applicant for CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX?

The FDA 510(k) record lists Tecnilatex S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX?

The FDA product code for CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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. BhdK001978'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.

↑