Cleared Traditional

Disposable Vinyl Examination Glove (K220469) - FDA 510(k) Clearance

Class I General Hospital device.

K220469 · Chifeng Huawei Medical Science&Technology Co., Ltd. · General Hospital
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Jun 2022
Decision
118d
Days
Class 1
Risk

K220469 is an FDA 510(k) clearance for the Disposable Vinyl Examination Glove. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Chifeng Huawei Medical Science&Technology Co., Ltd. (Chifeng, CN). The FDA issued a Cleared decision on June 16, 2022 after a review of 118 days - within the typical 510(k) review window.

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 Chifeng Huawei Medical Science&Technology Co., Ltd. devices

Submission Details

510(k) Number K220469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2022
Decision Date June 16, 2022
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K220469.
Disposable Vinyl Examination Gloves
K223008 · Jiangxi Handspro Products Solutions Co., Ltd. · Oct 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · Anhui Bytech Medical Supplies Co., Ltd. · Sep 2022
Disposable, vinyl examination gloves, Yellow
K220055 · Dezhou Hengchang Medical Technology Co., Ltd. · Aug 2022
Vinyl Co-Polymer Powder-free Examination Gloves, Black
K220240 · Grand Work Plastic Products Co., Ltd. · Mar 2022
Vinyl/Nitrile Blend Exam Glove
K213634 · Dezhou Hengchang Medical Technology Co., Ltd. · Feb 2022
Vinyl Examination Gloves
K213625 · Dezhou Hengchang Medical Technology Co., Ltd. · Feb 2022