Cleared Traditional

K082936 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K082936 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Zibo Litong 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 103-day FDA review.

K082936 · Zibo Litong Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
103d
Days
Class 1
Risk

K082936 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 Litong Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on January 12, 2009 after a review of 103 days - within the typical 510(k) review window.

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 - K082936

510(k) Number K082936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date January 12, 2009
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 K082936.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083047 · Zibo Wanci Plastic & Rubber Co., Ltd. · Feb 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082690 · Hebei Handform Plastic Products Co., Ltd. · Feb 2009
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082691 · Hebei Handform Plastic Products Co., Ltd. · Feb 2009
DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
K082448 · Rich Mountain Medical Products, Inc. · Dec 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082597 · Tangshan Linyuan Plastic Products Co., Ltd. · Oct 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082822 · Zibo Zhuangyuan Plastic Products Company · Oct 2008
K082936 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Zibo Litong Plastic P…