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FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue Color

K-Number: K211860 · 2021-08-13

ApplicantAnhui Powerguard Technology Co., Ltd.
Decision Date2021-08-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device manufactured by Anhui Powerguard Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-13 under approval number K211860. 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 2021-08-13. It is manufactured by Anhui Powerguard Technology Co., Ltd.. The 510(k) number is K211860.

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 2021-08-13, under approval number K211860.

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

Powder Free Nitrile Patient Examination Gloves, Blue Color is manufactured by Anhui Powerguard Technology 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 Anhui Powerguard Technology Co., Ltd.

K191292Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

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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