Cleared Traditional

K093263 - STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE

K093263 is an FDA 510(k) clearance for STRETCH 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 193-day FDA review.

K093263 · Qingdao Lang Hui Import & Export Co., Ltd. · General Hospital
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Apr 2010
Decision
193d
Days
Class 1
Risk

K093263 is an FDA 510(k) clearance for the STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE. 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 April 30, 2010 after a review of 193 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 - K093263

510(k) Number K093263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date April 30, 2010
Days to Decision 193 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 129d · This submission: 193d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K093263.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100697 · Shijiazhuang Universal Channel Plastic Co., Ltd. · May 2010
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
K092302 · Bettercare Plastic Products Co., Ltd. · May 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K100486 · Zibo Yinghao Medical Products Co., Ltd. · May 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100733 · Rayen Safety Products Limited · Apr 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100855 · Suzhou Shengyuda Plastic Products Co., Ltd. · Apr 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100392 · Tangshan Jiaxing Plastic Products Co., LT · Apr 2010
K093263 · STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
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