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FDA 510(k)

Disposable Nitrile Examination Gloves (Powder free, Blue)

K-Number: K211581 · 2021-10-28

ApplicantLeping Shengde Medical Technology Company Limited
Decision Date2021-10-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Gloves (Powder free, Blue) is a medical device manufactured by Leping Shengde Medical Technology Company Limited. It received FDA 510(k) clearance on 2021-10-28 under approval number K211581. 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 Nitrile Examination Gloves (Powder free, Blue)?

Disposable Nitrile Examination Gloves (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Leping Shengde Medical Technology Company Limited. The 510(k) number is K211581.

When was Disposable Nitrile Examination Gloves (Powder free, Blue) approved by the FDA?

Disposable Nitrile Examination Gloves (Powder free, Blue) received FDA 510(k) clearance on 2021-10-28, under approval number K211581.

What company makes Disposable Nitrile Examination Gloves (Powder free, Blue)?

Disposable Nitrile Examination Gloves (Powder free, Blue) is manufactured by Leping Shengde Medical Technology Company Limited.

What is the FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue)?

The FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue) 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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