Decision Date2021-08-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Exam Gloves, Powder Free, Blue is a medical device manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-20 under approval number K211699. 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 Exam Gloves, Powder Free, Blue?
Nitrile Exam Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211699.
When was Nitrile Exam Gloves, Powder Free, Blue approved by the FDA?
Nitrile Exam Gloves, Powder Free, Blue received FDA 510(k) clearance on 2021-08-20, under approval number K211699.
What company makes Nitrile Exam Gloves, Powder Free, Blue?
Nitrile Exam Gloves, Powder Free, Blue is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd..
What is the FDA product code for Nitrile Exam Gloves, Powder Free, Blue?
The FDA product code for Nitrile Exam Gloves, Powder Free, Blue is LZA.
Other Devices by Hengchang (Dongying) Medical Technology Co., Ltd.
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.