Cleared Traditional

K032907 - FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES

K032907 is an FDA 510(k) clearance for FUGUAN (BRAND) POWDERED VINYL PATIENT E..., manufactured by Shijiazhuang Fuguan Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K032907 · Shijiazhuang Fuguan Plastic Products Co., Ltd. · General Hospital
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Nov 2003
Decision
64d
Days
Class 1
Risk

K032907 is an FDA 510(k) clearance for the FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Fuguan Plastic Products Co., Ltd. (Chaoyang District; Beijing, CN). The FDA issued a Cleared decision on November 20, 2003 after a review of 64 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 Shijiazhuang Fuguan Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K032907

510(k) Number K032907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date November 20, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 318
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K032907.
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · Shen Wei (Usa), Inc. · Jan 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc. · Oct 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · Arista Latindo Industrial Ltd. P.T · Jul 2003