Cleared Traditional

K083015 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K083015 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Zibo Goldenline Plastic Product Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K083015 · Zibo Goldenline Plastic Product Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
152d
Days
Class 1
Risk

K083015 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 Goldenline Plastic Product Co., Ltd. (Chino, US). The FDA issued a Cleared decision on March 10, 2009 after a review of 152 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 - K083015

510(k) Number K083015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date March 10, 2009
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 K083015.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090691 · Shijiazhuang Benestar Plastic Co., Ltd. · May 2009
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · Quantum Co., Ltd. · Apr 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090537 · Tangshan Jiteng Plastic Products Co., Ltd. · Mar 2009
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
K083600 · Quantum Co., Ltd. · Feb 2009
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
K083259 · Tangshan Zhongying Plastic Products Co., Ltd. · Feb 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K090016 · Suqian Clean Glove Co., Ltd. · Feb 2009
K083015 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Zibo Goldenline Plast…