Cleared Traditional

K032792 - PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW

K032792 is an FDA 510(k) clearance for PRE-POWDERED, manufactured by Shanghai Jiawang Industrial Co. , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K032792 · Shanghai Jiawang Industrial Co. , Ltd. · General Hospital
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Oct 2003
Decision
37d
Days
Class 1
Risk

K032792 is an FDA 510(k) clearance for the PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Jiawang Industrial Co. , Ltd. (Sparks, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 37 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 - K032792

510(k) Number K032792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date October 15, 2003
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 K032792.
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES
K032745 · Shanghai Giantmax Plastic Product Corp. · Oct 2003
SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
K032746 · Shanghai Giantmax Plastic Product Corp. · Oct 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · Shanghai Foremost Plastic Industrial Co., Ltd. · Oct 2003
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K032323 · Long First (Xiamen) Plastics Co., Ltd. · Oct 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · Kingswell International, Inc. · Oct 2003
K032792 · PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
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