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FDA 510(k)

Disposable Powder Free Polyethylene Examination Gloves

K-Number: K212699 · 2022-05-31

ApplicantMastermax Plastic (Huizhou), Ltd.
Decision Date2022-05-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Polyethylene Examination Gloves is a medical device manufactured by Mastermax Plastic (Huizhou), Ltd.. It received FDA 510(k) clearance on 2022-05-31 under approval number K212699. 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 Disposable Powder Free Polyethylene Examination Gloves?

Disposable Powder Free Polyethylene Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Mastermax Plastic (Huizhou), Ltd.. The 510(k) number is K212699.

When was Disposable Powder Free Polyethylene Examination Gloves approved by the FDA?

Disposable Powder Free Polyethylene Examination Gloves received FDA 510(k) clearance on 2022-05-31, under approval number K212699.

What company makes Disposable Powder Free Polyethylene Examination Gloves?

Disposable Powder Free Polyethylene Examination Gloves is manufactured by Mastermax Plastic (Huizhou), Ltd..

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

The FDA product code for Disposable Powder Free Polyethylene Examination Gloves is LZA.

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Official Source

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