Cleared Traditional

K093264 - VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED

K093264 is an FDA 510(k) clearance for VINYL EXAMINATION GLOVE, manufactured by Qingdao Lang Hui Import & Export Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K093264 · Qingdao Lang Hui Import & Export Co., Ltd. · General Hospital
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May 2010
Decision
221d
Days
Class 1
Risk

K093264 is an FDA 510(k) clearance for the VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Qingdao Lang Hui Import & Export Co., Ltd. (Qingdao, Shandong, CN). The FDA issued a Cleared decision on May 28, 2010 after a review of 221 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 - K093264

510(k) Number K093264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date May 28, 2010
Days to Decision 221 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
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 750
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K093264.
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K101137 · Hongze Plastic Technology Co., Ltd. · Jun 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K101362 · Hebei Handform Plastic Products Co., Ltd. · Jun 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101341 · Shijiazhuang Universal Channel Plastic Co., Ltd. · Jun 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100699 · Shijiazhuang Star Plastic Co., Ltd. · May 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100856 · Suzhou Shengyuda Plastic Products Co., Ltd. · May 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100734 · Huanfu Plastic Products Limited · May 2010
K093264 · VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
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