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)

Medical Examination Gloves

K-Number: K212311 · 2021-10-21

ApplicantGuangzhou Junda Gloves Co., Ltd.
Decision Date2021-10-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Examination Gloves is a medical device manufactured by Guangzhou Junda Gloves Co., Ltd.. It received FDA 510(k) clearance on 2021-10-21 under approval number K212311. 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 Medical Examination Gloves?

Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Guangzhou Junda Gloves Co., Ltd.. The 510(k) number is K212311.

When was Medical Examination Gloves approved by the FDA?

Medical Examination Gloves received FDA 510(k) clearance on 2021-10-21, under approval number K212311.

What company makes Medical Examination Gloves?

Medical Examination Gloves is manufactured by Guangzhou Junda Gloves Co., Ltd..

What is the FDA product code for Medical Examination Gloves?

The FDA product code for Medical Examination Gloves is LZA.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT07537153 Genicular Artery Embolization for Knee Osteoarthritis RECRUITING NCT07587294 Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction NOT_YET_RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

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.

↑