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 Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

K-Number: K211714 · 2021-08-04

ApplicantHengchang (Dongying) Medical Technology Co., Ltd.
Decision Date2021-08-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is a medical device manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-04 under approval number K211714. 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 (Tested for Use with Chemotherapy)?

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is a medical device that received FDA 510(k) clearance on 2021-08-04. It is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211714.

When was Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) approved by the FDA?

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) received FDA 510(k) clearance on 2021-08-04, under approval number K211714.

What company makes Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)?

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd..

What is the FDA product code for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)?

The FDA product code for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) is LZA.

Related Clinical Trials

NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING NCT06823440 Prevention of CIPN Using Compressive Therapy RECRUITING

Other Devices by Hengchang (Dongying) Medical Technology Co., Ltd.

K211699Nitrile Exam Gloves, Powder Free, Blue

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.

↑