Cleared Traditional

K122656 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (FDA 510(k) Clearance)

Class I General Hospital device.

K122656 · Shandong Yifan Plastic Products Co., Ltd. · General Hospital
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May 2014
Decision
613d
Days
Class 1
Risk

K122656 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Yifan Plastic Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on May 6, 2014 after a review of 613 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Shandong Yifan Plastic Products Co., Ltd. devices

Submission Details

510(k) Number K122656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2012
Decision Date May 06, 2014
Days to Decision 613 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
484d slower than avg
Panel avg: 129d · This submission: 613d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K122656.
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Powder-Free Vinyl Exam Gloves, clear
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K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
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K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Mar 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · Ever Global (Vietnam) Enterprise Corporation · Feb 2023