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FDA 510(k)

Purism Non-Sterile Powder Free Nitrile Examination Gloves

K-Number: K211319 · 2021-08-19

ApplicantDezhou Purism Medical Technology Co., Ltd.
Decision Date2021-08-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Purism Non-Sterile Powder Free Nitrile Examination Gloves is a medical device manufactured by Dezhou Purism Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under approval number K211319. 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 Purism Non-Sterile Powder Free Nitrile Examination Gloves?

Purism Non-Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Dezhou Purism Medical Technology Co., Ltd.. The 510(k) number is K211319.

When was Purism Non-Sterile Powder Free Nitrile Examination Gloves approved by the FDA?

Purism Non-Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-19, under approval number K211319.

What company makes Purism Non-Sterile Powder Free Nitrile Examination Gloves?

Purism Non-Sterile Powder Free Nitrile Examination Gloves is manufactured by Dezhou Purism Medical Technology Co., Ltd..

What is the FDA product code for Purism Non-Sterile Powder Free Nitrile Examination Gloves?

The FDA product code for Purism Non-Sterile Powder Free Nitrile Examination Gloves 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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