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)

Powder Free Blue Nitrile Examination Glove

K-Number: K153732 · 2016-07-29

ApplicantQube Medical Product Sdn Bhd
Decision Date2016-07-29
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Blue Nitrile Examination Glove is a medical device manufactured by Qube Medical Product Sdn Bhd. It received FDA 510(k) clearance on 2016-07-29 under approval number K153732. 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 Powder Free Blue Nitrile Examination Glove?

Powder Free Blue Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Qube Medical Product Sdn Bhd. The 510(k) number is K153732.

When was Powder Free Blue Nitrile Examination Glove approved by the FDA?

Powder Free Blue Nitrile Examination Glove received FDA 510(k) clearance on 2016-07-29, under approval number K153732.

What company makes Powder Free Blue Nitrile Examination Glove?

Powder Free Blue Nitrile Examination Glove is manufactured by Qube Medical Product Sdn Bhd.

What is the FDA product code for Powder Free Blue Nitrile Examination Glove?

The FDA product code for Powder Free Blue Nitrile Examination Glove is LZA.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis 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.

↑