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FDA 510(k)

aoni Natural Rubber Latex Condom

K-Number: K153016 · 2016-10-20

ApplicantGuangzhou Daming United Rubber Products , Ltd.
Decision Date2016-10-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

aoni Natural Rubber Latex Condom is a medical device manufactured by Guangzhou Daming United Rubber Products , Ltd.. It received FDA 510(k) clearance on 2016-10-20 under approval number K153016. 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 aoni Natural Rubber Latex Condom?

aoni Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Guangzhou Daming United Rubber Products , Ltd.. The 510(k) number is K153016.

When was aoni Natural Rubber Latex Condom approved by the FDA?

aoni Natural Rubber Latex Condom received FDA 510(k) clearance on 2016-10-20, under approval number K153016.

What company makes aoni Natural Rubber Latex Condom?

aoni Natural Rubber Latex Condom is manufactured by Guangzhou Daming United Rubber Products , Ltd..

What is the FDA product code for aoni Natural Rubber Latex Condom?

The FDA product code for aoni Natural Rubber Latex Condom is HIS.

Related Devices (Code: HIS)

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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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