Dermoaroma Disposable Nitrile Examination Glove
K-Number: K212716 · 2021-12-27
Decision Date2021-12-27
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Dermoaroma Disposable Nitrile Examination Glove is a medical device manufactured by Chuzhou Harmony Gloves Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-12-27 under approval number K212716. 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 Dermoaroma Disposable Nitrile Examination Glove?
Dermoaroma Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-12-27. It is manufactured by Chuzhou Harmony Gloves Medical Technology Co.,Ltd. The 510(k) number is K212716.
When was Dermoaroma Disposable Nitrile Examination Glove approved by the FDA?
Dermoaroma Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-12-27, under approval number K212716.
What company makes Dermoaroma Disposable Nitrile Examination Glove?
Dermoaroma Disposable Nitrile Examination Glove is manufactured by Chuzhou Harmony Gloves Medical Technology Co.,Ltd.
What is the FDA product code for Dermoaroma Disposable Nitrile Examination Glove?
The FDA product code for Dermoaroma Disposable Nitrile Examination Glove 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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.