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)

First Glove Blue Nitrile Examination Gloves Powder Free

K-Number: K230958 · 2023-05-30

ApplicantFirst Glove Sdn. Bhd.
Decision Date2023-05-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

First Glove Blue Nitrile Examination Gloves Powder Free is a medical device manufactured by First Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-05-30 under approval number K230958. 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 First Glove Blue Nitrile Examination Gloves Powder Free?

First Glove Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-05-30. It is manufactured by First Glove Sdn. Bhd.. The 510(k) number is K230958.

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

First Glove Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2023-05-30, under approval number K230958.

What company makes First Glove Blue Nitrile Examination Gloves Powder Free?

First Glove Blue Nitrile Examination Gloves Powder Free is manufactured by First Glove Sdn. Bhd..

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

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

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT07467915 Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke RECRUITING NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING

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.

↑