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FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue Color

K-Number: K210777 · 2021-11-02

ApplicantShandong Jieshi Medical Products Co., Ltd.
Decision Date2021-11-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

When was Powder Free Nitrile Patient Examination Gloves, Blue Color approved by the FDA?

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

What company makes Powder Free Nitrile Patient Examination Gloves, Blue Color?

Powder Free Nitrile Patient Examination Gloves, Blue Color is manufactured by Shandong Jieshi Medical Products Co., Ltd..

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.

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Other Devices by Shandong Jieshi Medical Products Co., Ltd.

K210774Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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