Cleared Traditional

K051152 - POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

K051152 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Zibo Sinocare 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 30-day FDA review.

K051152 · Zibo Sinocare Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
30d
Days
Class 1
Risk

K051152 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Sinocare Plastic Products Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on June 3, 2005 after a review of 30 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.

View all Zibo Sinocare Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K051152

510(k) Number K051152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date June 03, 2005
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 660
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K051152.
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
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET
K051166 · Gloveco, Inc. · Jun 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051153 · Hebei Manful Import & Export Co., Ltd. · May 2005
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
K050450 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · Apr 2005
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
K050455 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · Mar 2005