Cleared Traditional

K083600 - VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)

K083600 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVE, manufactured by Quantum Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K083600 · Quantum Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
76d
Days
Class 1
Risk

K083600 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Quantum Co., Ltd. (Shandong, CN). The FDA issued a Cleared decision on February 19, 2009 after a review of 76 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 - K083600

510(k) Number K083600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date February 19, 2009
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 750
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K083600.
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · Quantum Co., Ltd. · Apr 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · Tangshan Jiteng Plastic Products Co., Ltd. · Mar 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · Zibo Goldenline Plastic Product Co., Ltd. · Mar 2009
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
K083259 · Tangshan Zhongying Plastic Products Co., Ltd. · Feb 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K090016 · Suqian Clean Glove Co., Ltd. · Feb 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083047 · Zibo Wanci Plastic & Rubber Co., Ltd. · Feb 2009
K083600 · VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
Download PDF FDA Summary Quantum Co., Ltd.