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FDA 510(k)

H2H Powder Free Examination Blue Glove

K-Number: K211182 · 2021-08-01

ApplicantNtl Innovation Co., Ltd.
Decision Date2021-08-01
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

H2H Powder Free Examination Blue Glove is a medical device manufactured by Ntl Innovation Co., Ltd.. It received FDA 510(k) clearance on 2021-08-01 under approval number K211182. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H2H Powder Free Examination Blue Glove?

H2H Powder Free Examination Blue Glove is a medical device that received FDA 510(k) clearance on 2021-08-01. It is manufactured by Ntl Innovation Co., Ltd.. The 510(k) number is K211182.

When was H2H Powder Free Examination Blue Glove approved by the FDA?

H2H Powder Free Examination Blue Glove received FDA 510(k) clearance on 2021-08-01, under approval number K211182.

What company makes H2H Powder Free Examination Blue Glove?

H2H Powder Free Examination Blue Glove is manufactured by Ntl Innovation Co., Ltd..

What is the FDA product code for H2H Powder Free Examination Blue Glove?

The FDA product code for H2H Powder Free Examination Blue Glove is LZA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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