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)

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

K-Number: K190876 · 2019-12-02

ApplicantMercator Medical (Thailand), Ltd.
Decision Date2019-12-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is a medical device manufactured by Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2019-12-02 under approval number K190876. 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 mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Mercator Medical (Thailand), Ltd.. The 510(k) number is K190876.

When was mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed approved by the FDA?

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed received FDA 510(k) clearance on 2019-12-02, under approval number K190876.

What company makes mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is manufactured by Mercator Medical (Thailand), Ltd..

What is the FDA product code for mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

The FDA product code for mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is LZA.

Related Clinical Trials

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 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 NCT04105374 Testing the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma WITHDRAWN NCT04034251 Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis TERMINATED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Related PubMed Literature

PMID: 41343216 Describing Inconsistencies in Pediatric Labeling of Medical Devices. JAMA network open (2025)

Other Devices by Mercator Medical (Thailand), Ltd.

K172930mCare Powder-free Blue Nitrile Examination Gloves K192444mCare® Powder Free Nitrile Black Examination Glove K200967mCare(R) Powder Free Nitrile Orange Examination Gloves K213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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.

↑