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FDA 510(k)

Disposible Nitrile Gloves

K-Number: K223280 · 2023-05-08

ApplicantHolik Asia Group Co.,Ltd
Decision Date2023-05-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposible Nitrile Gloves is a medical device manufactured by Holik Asia Group Co.,Ltd. It received FDA 510(k) clearance on 2023-05-08 under approval number K223280. 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 Disposible Nitrile Gloves?

Disposible Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2023-05-08. It is manufactured by Holik Asia Group Co.,Ltd. The 510(k) number is K223280.

When was Disposible Nitrile Gloves approved by the FDA?

Disposible Nitrile Gloves received FDA 510(k) clearance on 2023-05-08, under approval number K223280.

What company makes Disposible Nitrile Gloves?

Disposible Nitrile Gloves is manufactured by Holik Asia Group Co.,Ltd.

What is the FDA product code for Disposible Nitrile Gloves?

The FDA product code for Disposible Nitrile Gloves is LZA.

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

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

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