Cleared Traditional

Medical Gloves (K203622) - FDA 510(k) Clearance

Class I General Hospital device.

K203622 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
252d
Days
Class 1
Risk

K203622 is an FDA 510(k) clearance for the Medical Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 20, 2021 after a review of 252 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Biosis Healing Biolog Ical Technology Co., Ltd. devices

Submission Details

510(k) Number K203622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K203622.
Disposable Nitrile Examination Gloves
K210897 · Shandong DS Safety Technology Co., Ltd. · Aug 2021
Nitrile Examination Gloves
K211515 · Beijing Reagent Latex Products Co., Ltd. · Aug 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
K201857 · Careplus (M) Sdn Bhd · Aug 2021
Nitrile Exam Gloves, Powder Free, Blue
K211699 · Hengchang (Dongying) Medical Technology Co., Ltd. · Aug 2021
Purism Non-Sterile Powder Free Nitrile Examination Gloves
K211319 · Dezhou Purism Medical Technology Co., Ltd. · Aug 2021
Disposable Medical Nitrile Gloves
K211708 · Jiangsu Health-Peace Medical Technology Co., Ltd. · Aug 2021