Cleared Traditional

Nitrile Examination Gloves

K210706 · Niujian Technology Co., Ltd. · General Hospital
Oct 2021
Decision
223d
Days
Class 1
Risk

About This 510(k) Submission

K210706 is an FDA 510(k) clearance for the 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 October 19, 2021, 223 days after receiving the submission on March 10, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K210706 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2021
Decision Date October 19, 2021
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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