Cleared Traditional

K032323 - BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

K032323 is an FDA 510(k) clearance for BROTHERS POWDERED SYNTHETIC VINYL PATIE..., manufactured by Long First (Xiamen) Plastics Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K032323 · Long First (Xiamen) Plastics Co., Ltd. · General Hospital
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Oct 2003
Decision
71d
Days
Class 1
Risk

K032323 is an FDA 510(k) clearance for the BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Long First (Xiamen) Plastics Co., Ltd. (Chicago, US). The FDA issued a Cleared decision on October 7, 2003 after a review of 71 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 - K032323

510(k) Number K032323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2003
Decision Date October 07, 2003
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K032323.
SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
K032746 · Shanghai Giantmax Plastic Product Corp. · Oct 2003
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
K032792 · Shanghai Jiawang Industrial Co. , Ltd. · Oct 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · Shanghai Foremost Plastic Industrial Co., Ltd. · Oct 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · Kingswell International, Inc. · Oct 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032630 · Kingswell International, Inc. · Oct 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032616 · Elite International, Inc. · Oct 2003
K032323 · BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
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