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)

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim

K-Number: K233405 · 2023-12-28

ApplicantEco Medi Glove Sdn. Bhd.
Decision Date2023-12-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is a medical device manufactured by Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-12-28 under approval number K233405. 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 Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is a medical device that received FDA 510(k) clearance on 2023-12-28. It is manufactured by Eco Medi Glove Sdn. Bhd.. The 510(k) number is K233405.

When was Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim approved by the FDA?

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim received FDA 510(k) clearance on 2023-12-28, under approval number K233405.

What company makes Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim is manufactured by Eco Medi Glove Sdn. Bhd..

What is the FDA product code for Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim?

The FDA product code for Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim 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 NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING

Other Devices by Eco Medi Glove Sdn. Bhd.

K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs K161320EMG Pink Nitrile Examination Glove Powder Free K152937EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

View all 11 devices →

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.

↑