Cleared Traditional

K081658 - POWDER-FREE VINYL EXAMINATION GLOVES

K081658 is an FDA 510(k) clearance for POWDER-FREE VINYL EXAMINATION GLOVES, manufactured by Jiangsu Alfa Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K081658 · Jiangsu Alfa Glove 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
110d
Days
Class 1
Risk

K081658 is an FDA 510(k) clearance for the POWDER-FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Alfa Glove Co., Ltd. (Haidian Dis, Beijing, CN). The FDA issued a Cleared decision on September 30, 2008 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081658

510(k) Number K081658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date September 30, 2008
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
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 K081658.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082597 · Tangshan Linyuan Plastic Products Co., Ltd. · Oct 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082822 · Zibo Zhuangyuan Plastic Products Company · Oct 2008
DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE
K082447 · Rich Mountain Medical Products, Inc. · Oct 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
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
K082029 · Ever Light Plastic Products Co., Ltd. · Sep 2008
K081658 · POWDER-FREE VINYL EXAMINATION GLOVES
Download PDF FDA Summary Jiangsu Alfa Glove Co…