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)

EONS Nitrile Examination Gloves Powder Free

K-Number: K213286 · 2022-02-19

ApplicantEons Gloves (Thailand) Co., Ltd.
Decision Date2022-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EONS Nitrile Examination Gloves Powder Free is a medical device manufactured by Eons Gloves (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2022-02-19 under approval number K213286. 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 EONS Nitrile Examination Gloves Powder Free?

EONS Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Eons Gloves (Thailand) Co., Ltd.. The 510(k) number is K213286.

When was EONS Nitrile Examination Gloves Powder Free approved by the FDA?

EONS Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2022-02-19, under approval number K213286.

What company makes EONS Nitrile Examination Gloves Powder Free?

EONS Nitrile Examination Gloves Powder Free is manufactured by Eons Gloves (Thailand) Co., Ltd..

What is the FDA product code for EONS Nitrile Examination Gloves Powder Free?

The FDA product code for EONS Nitrile Examination Gloves Powder Free is LZA.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

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.

↑