Cleared Traditional

K213144 - Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

K213144 is an FDA 510(k) clearance for Biodegradable Powder Free Vinyl Examina..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K213144

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.

LYZ Device Classification - Class 1, General Controls

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 383
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