Cleared Traditional

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs

K220353 · Niujian Technology Co., Ltd. · General Hospital

Mar 2022

Decision

51d

Days

Class 1

Risk

About This 510(k) Submission

K220353 is an FDA 510(k) clearance for the Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Niujian Technology Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on March 31, 2022, 51 days after receiving the submission on February 8, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K220353 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2022
Decision Date	March 31, 2022
Days to Decision	51 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LZC — Medical Glove, Specialty
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.