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FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue Color

K-Number: K210777 · 2021-11-02

Decision Date2021-11-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Patient Examination Gloves, Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Jieshi Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-11-02 under 510(k) number K210777. 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 Powder Free Nitrile Patient Examination Gloves, Blue Color?

Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Shandong Jieshi Medical Products Co., Ltd.. The 510(k) number is K210777.

When did Powder Free Nitrile Patient Examination Gloves, Blue Color receive FDA 510(k) clearance?

Powder Free Nitrile Patient Examination Gloves, Blue Color received FDA 510(k) clearance on 2021-11-02, under 510(k) number K210777.

Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Blue Color?

The FDA 510(k) record lists Shandong Jieshi Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color is LZA.

Other records listing Shandong Jieshi Medical Products 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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