Cleared Traditional

K091431 - POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

K091431 is an FDA 510(k) clearance for POWDER-FREE, manufactured by Zibo Yusheng 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 56-day FDA review.

K091431 · Zibo Yusheng Plastic Products Co., Ltd. · General Hospital
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Jul 2009
Decision
56d
Days
Class 1
Risk

K091431 is an FDA 510(k) clearance for the POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Yusheng Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on July 8, 2009 after a review of 56 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.

FDA 510(k) Submission Details - K091431

510(k) Number K091431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date July 08, 2009
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K091431.
VINYL POWDER FREE EXAMINATION GLOVE
K091429 · Shun DA (Xinghua) Co., Ltd. · Jul 2009
VINYL POWDERED EXAMINATION GLOVE
K091384 · Shun Tong Co., Ltd. · Jul 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K091523 · Shijiazhuang Century Plastic Co., Ltd. · Jul 2009
VINYL POWDERED EXAMINATION GLOVE
K091427 · Shun DA (Xinghua) Co., Ltd. · Jun 2009
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
K090520 · Shandong Huayue Glove Co., Ltd. · May 2009
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · Shandong Huayue Glove Co., Ltd. · May 2009
K091431 · POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
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