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FDA 510(k)

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

K-Number: K001978 · 2000-08-08

ApplicantThai Nippon Rubber Industry Co., Ltd.
Decision Date2000-08-08
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Co., Ltd.. It received FDA 510(k) clearance on 2000-08-08 under 510(k) number K001978. 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 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9?

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 is a medical device that received FDA 510(k) clearance on 2000-08-08. The listed applicant is Thai Nippon Rubber Industry Co., Ltd.. The 510(k) number is K001978.

When did 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 receive FDA 510(k) clearance?

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 received FDA 510(k) clearance on 2000-08-08, under 510(k) number K001978.

Who is the listed applicant for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9?

The FDA 510(k) record lists Thai Nippon Rubber Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9?

The FDA product code for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 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 Thai Nippon Rubber Industry Co., Ltd. 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.

K081265THAI NIPPON MALE LATEX CONDOMK032909THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOMK011253FLAVORED MALE LATEX CONDOMK994095LATEX CONDOM

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.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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