Cleared Traditional

Medical Gloves

K203622 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General Hospital
Aug 2021
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K203622 is an FDA 510(k) clearance for the Medical Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 20, 2021, 252 days after receiving the submission on December 11, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K203622 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2020
Decision Date August 20, 2021
Days to Decision 252 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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