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FDA 510(k)

Nitrile Patient Examination Glove

K-Number: K222527 · 2022-12-14

ApplicantPingan Medical Products Co., Ltd.
Decision Date2022-12-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Glove is a medical device manufactured by Pingan Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under approval number K222527. 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 Patient Examination Glove?

Nitrile Patient Examination Glove is a medical device that received FDA 510(k) clearance on 2022-12-14. It is manufactured by Pingan Medical Products Co., Ltd.. The 510(k) number is K222527.

When was Nitrile Patient Examination Glove approved by the FDA?

Nitrile Patient Examination Glove received FDA 510(k) clearance on 2022-12-14, under approval number K222527.

What company makes Nitrile Patient Examination Glove?

Nitrile Patient Examination Glove is manufactured by Pingan Medical Products Co., Ltd..

What is the FDA product code for Nitrile Patient Examination Glove?

The FDA product code for Nitrile Patient Examination Glove is LZA.

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Other Devices by Pingan Medical Products Co., Ltd.

K182115Vinyl Patient Examination Gloves K210725Nitrile Patient Examination Glove

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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