Cleared Traditional

Nitrile Examination Gloves (Powder free, Blue)

K213029 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Dec 2021
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K213029 is an FDA 510(k) clearance for the Nitrile Examination Gloves (Powder free, Blue), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on December 14, 2021, 84 days after receiving the submission on September 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K213029 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2021
Decision Date December 14, 2021
Days to Decision 84 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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