Cleared Traditional

K213144 - Biodegradable Powder Free Vinyl Examina...

K213144 is the FDA 510(k) clearance for Biodegradable Powder Free Vinyl Examina... by Shen Wei (Usa), Inc.. It is a Class 1 General Hospital device (product code LYZ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K213144 · Shen Wei (Usa), Inc. · General Hospital
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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
43d faster than avg
Panel avg: 129d · 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.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 90
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K213144.
Vinyl Powder Free Examination Glove
K212011 · Top Glove Vietnam Company Limited · Feb 2022
Vinyl Exam Gloves
K213019 · Hebei Astro Medical Supply Co., Ltd. · Jan 2022
NBR Synthetic Nitrile Examination Gloves
K212436 · Shandong Langtai International Trade Co., Ltd. · Dec 2021
Vinyl Examination Gloves
K213006 · Taian Hengchang Medical Technology Co., Ltd. · Dec 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K211865 · Liao Ning Shangwei Medical Products Co., Ltd. · Dec 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899 · Bytech Dongtai Co., Ltd. · Dec 2021