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FDA 510(k)

Powder Free Vinyl Examination Gloves

K-Number: K211103 · 2021-11-04

ApplicantShanghai Shengda Medical Applications Co., Ltd.
Decision Date2021-11-04
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Vinyl Examination Gloves is a medical device manufactured by Shanghai Shengda Medical Applications Co., Ltd.. It received FDA 510(k) clearance on 2021-11-04 under approval number K211103. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Vinyl Examination Gloves?

Powder Free Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Shanghai Shengda Medical Applications Co., Ltd.. The 510(k) number is K211103.

When was Powder Free Vinyl Examination Gloves approved by the FDA?

Powder Free Vinyl Examination Gloves received FDA 510(k) clearance on 2021-11-04, under approval number K211103.

What company makes Powder Free Vinyl Examination Gloves?

Powder Free Vinyl Examination Gloves is manufactured by Shanghai Shengda Medical Applications Co., Ltd..

What is the FDA product code for Powder Free Vinyl Examination Gloves?

The FDA product code for Powder Free Vinyl Examination Gloves is LYZ.

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Official Source

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