Cleared Traditional

K122828 - POWDER-FREE VINYL PATIENT EXAMINATION G...

K122828 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shandong Hongxin Chemicals Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K122828 · Shandong Hongxin Chemicals Co., Ltd. · General Hospital
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Dec 2012
Decision
84d
Days
Class 1
Risk

K122828 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Hongxin Chemicals Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 10, 2012 after a review of 84 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 Shandong Hongxin Chemicals Co., Ltd. devices

FDA 510(k) Submission Details - K122828

510(k) Number K122828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2012
Decision Date December 10, 2012
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 100
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K122828.
Vinyl Patient Examination Glove (Yellow)
K173561 · Yurun Glove Co., Ltd. · Feb 2018
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · Cardinal Health, Inc. · Jul 2016
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004