Cleared Traditional

K112266 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR

K112266 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shandong Zhiyuan Medical 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 274-day FDA review.

K112266 · Shandong Zhiyuan Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
274d
Days
Class 1
Risk

K112266 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Zhiyuan Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 274 days - an extended review 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: 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 - K112266

510(k) Number K112266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2011
Decision Date May 08, 2012
Days to Decision 274 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 129d · This submission: 274d
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 K112266.
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
K120584 · Wealth on (Jiangsu) Co., Ltd. · Jul 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K113194 · Suqian Ruijang Medical Supplies Co., Ltd. · May 2012
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
K120798 · Canopus Medical Supply Co., Ltd. · May 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K113837 · Hebei Changsheng Plastic Products Co., Ltd. · Apr 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K120746 · Canopus Medical Supply Co., Ltd. · Apr 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K120190 · Rich Mountain Medical Products, Inc. · Apr 2012
K112266 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Download PDF FDA Summary Shandong Zhiyuan Medi…