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)

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

K-Number: K162510 · 2017-07-18

ApplicantUg Global Resources Sdn. Bhd.
Decision Date2017-07-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a medical device manufactured by Ug Global Resources Sdn. Bhd.. It received FDA 510(k) clearance on 2017-07-18 under approval number K162510. 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 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a medical device that received FDA 510(k) clearance on 2017-07-18. It is manufactured by Ug Global Resources Sdn. Bhd.. The 510(k) number is K162510.

When was Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue approved by the FDA?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue received FDA 510(k) clearance on 2017-07-18, under approval number K162510.

What company makes Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is manufactured by Ug Global Resources Sdn. Bhd..

What is the FDA product code for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue?

The FDA product code for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue 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

Other Devices by Ug Global Resources Sdn. Bhd.

K161961UniTex Non-Sterile, Powder-Free, Latex Examination Glove K232319Black Pearl Nitrile Examination Glove

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.

↑