Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Medical Nitrile Gloves

K-Number: K211708 · 2021-08-17

ApplicantJiangsu Health-Peace Medical Technology Co., Ltd.
Decision Date2021-08-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Gloves is a medical device manufactured by Jiangsu Health-Peace Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-17 under approval number K211708. 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 Disposable Medical Nitrile Gloves?

Disposable Medical Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2021-08-17. It is manufactured by Jiangsu Health-Peace Medical Technology Co., Ltd.. The 510(k) number is K211708.

When was Disposable Medical Nitrile Gloves approved by the FDA?

Disposable Medical Nitrile Gloves received FDA 510(k) clearance on 2021-08-17, under approval number K211708.

What company makes Disposable Medical Nitrile Gloves?

Disposable Medical Nitrile Gloves is manufactured by Jiangsu Health-Peace Medical Technology Co., Ltd..

What is the FDA product code for Disposable Medical Nitrile Gloves?

The FDA product code for Disposable Medical Nitrile Gloves is LZA.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

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.

↑