Cleared Traditional

K082029 - SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE

K082029 is an FDA 510(k) clearance for SYNTHETIC POWDER FREE (PINK) VINYL PATI..., manufactured by Ever Light 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 71-day FDA review.

K082029 · Ever Light Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
71d
Days
Class 1
Risk

K082029 is an FDA 510(k) clearance for the SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ever Light Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on September 26, 2008 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 - K082029

510(k) Number K082029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date September 26, 2008
Days to Decision 71 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
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 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K082029.
POWDER-FREE VINYL EXAMINATION GLOVES
K081658 · Jiangsu Alfa Glove Co., Ltd. · Sep 2008
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
K082444 · Rich Mountain Medical Products, Inc. · Sep 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K081539 · Rich Mountain Medical Products, Inc. · Sep 2008
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K082443 · Rich Mountain Medical Products, Inc. · Sep 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
K081657 · Jiangsu Cureguard Glove Co., Ltd. · Aug 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K081535 · Rich Mountain Medical Products, Inc. · Aug 2008
K082029 · SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
Download PDF FDA Summary Ever Light Plastic Pr…