FDA 510(k)

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)

K-Number: K213662 · 2022-03-28

ApplicantTaishan Weibang Medical Equipment Co., Ltd.

Decision Date2022-03-28

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Taishan Weibang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-28 under approval number K213662. 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 Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)?

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-03-28. It is manufactured by Taishan Weibang Medical Equipment Co., Ltd.. The 510(k) number is K213662.

When was Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) approved by the FDA?

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-03-28, under approval number K213662.

What company makes Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)?

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) is manufactured by Taishan Weibang Medical Equipment Co., Ltd..

What is the FDA product code for Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) is LZA.

Related Clinical Trials

NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07067138 A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast) SUSPENDED 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Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma WITHDRAWN NCT04034251 Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis TERMINATED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 NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

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.