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FDA 510(k)

One Touch Condom with Benzocaine

K-Number: K171213 · 2018-01-12

ApplicantThai Nippon Rubber Industry Public Company Limited.
Decision Date2018-01-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

One Touch Condom with Benzocaine is a medical device manufactured by Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2018-01-12 under approval number K171213. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One Touch Condom with Benzocaine?

One Touch Condom with Benzocaine is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K171213.

When was One Touch Condom with Benzocaine approved by the FDA?

One Touch Condom with Benzocaine received FDA 510(k) clearance on 2018-01-12, under approval number K171213.

What company makes One Touch Condom with Benzocaine?

One Touch Condom with Benzocaine is manufactured by Thai Nippon Rubber Industry Public Company Limited..

What is the FDA product code for One Touch Condom with Benzocaine?

The FDA product code for One Touch Condom with Benzocaine is HIS.

Other Devices by Thai Nippon Rubber Industry Public Company Limited.

K210095Playboy Premium Silicone Lubricant K211450Playboy 3 Contour Condom K210294One Touch Spiral Condom K220273Onetouch Non-paraben Lubricant Gel

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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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