Cleared Traditional

K092416 - POWDERED VINYL PATIENT EXAMINATION GLOVES

K092416 is an FDA 510(k) clearance for POWDERED VINYL PATIENT EXAMINATION GLOVES, manufactured by Shijiazhuang Elegance Plastic Product. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K092416 · Shijiazhuang Elegance Plastic Product · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
41d
Days
Class 1
Risk

K092416 is an FDA 510(k) clearance for the POWDERED VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Elegance Plastic Product (Haidian District, Beijing, CN). The FDA issued a Cleared decision on September 16, 2009 after a review of 41 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 - K092416

510(k) Number K092416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date September 16, 2009
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K092416.
POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
K091942 · Zibo Intco Medical Products Co., Ltd. · Sep 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K092000 · Shangdong Zibo Shanchuan Medical Instruments Co. · Sep 2009
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
K092100 · Tangshan Hongxing Plastic Products Co., Ltd. · Sep 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090551 · Tangshan Zhongpu Plastic Products Co., Ltd. · Aug 2009
POWERED VINYL PATIENT EXAMINATION GLOVES
K091521 · Shijiazhuang Century Plastic Co., Ltd. · Aug 2009
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
K091422 · Novapro Co., Ltd. · Jul 2009
K092416 · POWDERED VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shijiazhuang Elegance…