Cleared Traditional

K051166 - POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET

K051166 is an FDA 510(k) clearance for POWDER FREE VINYL SYNTHETIC EXAMINATION..., manufactured by Gloveco, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K051166 · Gloveco, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
33d
Days
Class 1
Risk

K051166 is an FDA 510(k) clearance for the POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Gloveco, Inc. (Chino, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 33 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 - K051166

510(k) Number K051166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2005
Decision Date June 07, 2005
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 K051166.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K051148 · Zibo Sinocare Plastic Products Co., Ltd. · Jun 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051154 · Hebei Manful Import & Export Co., Ltd. · Jun 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
K051156 · Shijiazhuang Manful Light Industrial Products Co., · Jun 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051152 · Zibo Sinocare Plastic Products Co., Ltd. · Jun 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051153 · Hebei Manful Import & Export Co., Ltd. · May 2005
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
K040916 · Vitalcare Group, Inc. · May 2005
K051166 · POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET
Download PDF FDA Summary Gloveco, Inc.