Cleared Traditional

K051156 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)

K051156 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shijiazhuang Manful Light Industrial Products Co.,. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K051156 · Shijiazhuang Manful Light Industrial Products Co., · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
41d
Days
Class 1
Risk

K051156 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Manful Light Industrial Products Co., (Haidian District, Beijing, CN). The FDA issued a Cleared decision on June 14, 2005 after a review of 41 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 - K051156

510(k) Number K051156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date June 14, 2005
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K051156.
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
K051498 · Ever Global Enterprise Corporation · Jul 2005
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 SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET
K051166 · Gloveco, Inc. · 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
K051156 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
Download PDF FDA Summary Shijiazhuang Manful L…