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FDA 510(k)

Nitrile Glove

K-Number: K211252 · 2021-06-25

Decision Date2021-06-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Glove is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Dihong Industry and Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211252. 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 Nitrile Glove?

Nitrile Glove is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Jiangsu Dihong Industry and Trade Co., Ltd.. The 510(k) number is K211252.

When did Nitrile Glove receive FDA 510(k) clearance?

Nitrile Glove received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211252.

Who is the listed applicant for Nitrile Glove?

The FDA 510(k) record lists Jiangsu Dihong Industry and Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Glove?

The FDA product code for Nitrile Glove is LZA.

Other records listing Jiangsu Dihong Industry and Trade 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.