Cleared Traditional

K093272 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K093272 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Tangshan Huamei Healthcare Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K093272 · Tangshan Huamei Healthcare Co., Ltd. · General Hospital
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Nov 2009
Decision
42d
Days
Class 1
Risk

K093272 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 Tangshan Huamei Healthcare Co., Ltd. (Haidian Dis, Beijing, CN). The FDA issued a Cleared decision on November 30, 2009 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tangshan Huamei Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K093272

510(k) Number K093272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date November 30, 2009
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
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 682
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K093272.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092956 · Shandong Aobo Medical Co, Ltd. · Dec 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K093570 · Jiangsu Jaysun Glove Co., Ltd. · Dec 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092820 · Shijiazhuang Fuhao Plastic Products Co., Ltd. · Dec 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093277 · Tangshan Green Healthcare Co., Ltd. · Nov 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093270 · Tangshan Excellence Glove Co., Ltd. · Nov 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093276 · Tangshan Kangyuan Glove Co., Ltd. · Nov 2009