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)

Nitrile Examination Gloves (Model: ZMG1351)

K-Number: K213688 · 2022-02-18

ApplicantWuhan Zonsen Medical Products Co., Ltd.
Decision Date2022-02-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves (Model: ZMG1351) is a medical device manufactured by Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under approval number K213688. 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 Examination Gloves (Model: ZMG1351)?

Nitrile Examination Gloves (Model: ZMG1351) is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K213688.

When was Nitrile Examination Gloves (Model: ZMG1351) approved by the FDA?

Nitrile Examination Gloves (Model: ZMG1351) received FDA 510(k) clearance on 2022-02-18, under approval number K213688.

What company makes Nitrile Examination Gloves (Model: ZMG1351)?

Nitrile Examination Gloves (Model: ZMG1351) is manufactured by Wuhan Zonsen Medical Products Co., Ltd..

What is the FDA product code for Nitrile Examination Gloves (Model: ZMG1351)?

The FDA product code for Nitrile Examination Gloves (Model: ZMG1351) is LZA.

Related Clinical Trials

NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Wuhan Zonsen Medical Products Co., Ltd.

K212861Surgical Gown, Reinforced Surgical Gown K202191Surgical Mask K213601Surgical Mask K212357Surgical isolation gown K223600Sterilization Wrap

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.

↑