Cleared Traditional

K103772 - VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)

K103772 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, manufactured by Advanced Medical Devices Factory. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K103772 · Advanced Medical Devices Factory · General Hospital
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Feb 2011
Decision
60d
Days
Class 1
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K103772 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Advanced Medical Devices Factory (Weifang, Shandong, CN). The FDA issued a Cleared decision on February 25, 2011 after a review of 60 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.

FDA 510(k) Submission Details - K103772

510(k) Number K103772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date February 25, 2011
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K103772.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110338 · Zibo Yuechuan Plastic Products Co., Ltd. · Apr 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102085 · Shijiazhuang Glory Plastic Co., Ltd. · Apr 2011
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE
K110224 · Weifang Beihai Color Printing Packagging Co., Ltd. · Mar 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102613 · Hebei Favor Plastic Co., Ltd. · Jan 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102817 · Hebei Hongtai Plastic Products Co., Ltd. · Dec 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102819 · Hebei Hongtai Plastic Products Co., Ltd. · Dec 2010
K103772 · VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
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