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FDA 510(k)

Non-spermicidal Lubricated Male Latex Condom

K-Number: K193578 · 2020-08-20

ApplicantGlobal Protection Corp.
Decision Date2020-08-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Non-spermicidal Lubricated Male Latex Condom is a medical device manufactured by Global Protection Corp.. It received FDA 510(k) clearance on 2020-08-20 under approval number K193578. 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 Non-spermicidal Lubricated Male Latex Condom?

Non-spermicidal Lubricated Male Latex Condom is a medical device that received FDA 510(k) clearance on 2020-08-20. It is manufactured by Global Protection Corp.. The 510(k) number is K193578.

When was Non-spermicidal Lubricated Male Latex Condom approved by the FDA?

Non-spermicidal Lubricated Male Latex Condom received FDA 510(k) clearance on 2020-08-20, under approval number K193578.

What company makes Non-spermicidal Lubricated Male Latex Condom?

Non-spermicidal Lubricated Male Latex Condom is manufactured by Global Protection Corp..

What is the FDA product code for Non-spermicidal Lubricated Male Latex Condom?

The FDA product code for Non-spermicidal Lubricated Male Latex Condom is 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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