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FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves

K-Number: K220354 · 2022-03-24

Decision Date2022-03-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220354. 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 Medical Synthetic Nitrile Examination Gloves?

Disposable Medical Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Niujian Technology Co., Ltd.. The 510(k) number is K220354.

When did Disposable Medical Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220354.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Niujian Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves is LZA.

Other records listing Niujian Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.