Cleared Traditional

Disposable Medical Synthetic Nitrile Examination Gloves

K220354 · Niujian Technology Co., Ltd. · General Hospital
Mar 2022
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K220354 is an FDA 510(k) clearance for the Disposable Medical Synthetic Nitrile Examination Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Niujian Technology Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on March 24, 2022, 44 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 K220354 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2022
Decision Date March 24, 2022
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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