Cleared Traditional

K213144 - Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors (FDA 510(k) Clearance)

Class I General Hospital device.

K213144 · Shen Wei (Usa), Inc. · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Dec 2021

Decision

86d

Days

Class 1

Risk

K213144 is an FDA 510(k) clearance for the Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on December 22, 2021 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shen Wei (Usa), Inc. devices

Submission Details

510(k) Number	K213144 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 2021
Decision Date	December 22, 2021
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

42d faster than avg

Panel avg: 128d · This submission: 86d

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.