Cleared Traditional

K110536 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K110536 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Zibo Tengyue 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 388-day FDA review.

K110536 · Zibo Tengyue Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
388d
Days
Class 1
Risk

K110536 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Tengyue Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on March 19, 2012 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K110536

510(k) Number K110536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date March 19, 2012
Days to Decision 388 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
259d slower than avg
Panel avg: 129d · This submission: 388d
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 K110536.
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
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K113749 · Full Synergy Medical Products, Inc. · Mar 2012
DISPOSABLE VINYL EXAM GLOVE, POWDERED
K113790 · Full Synergy Medical Products, Inc. · Mar 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120358 · Hongxin Plastic Products Co., Ltd. · Mar 2012
K110536 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Zibo Tengyue Plastic …