Cleared Traditional

K122102 - POWER FREE VINYL EXAMINATION GLOVES

K122102 is an FDA 510(k) clearance for POWER FREE VINYL EXAMINATION GLOVES, manufactured by Wang Tong Xinghua Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K122102 · Wang Tong Xinghua Co., Ltd. · General Hospital
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Sep 2013
Decision
420d
Days
Class 1
Risk

K122102 is an FDA 510(k) clearance for the POWER FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Wang Tong Xinghua Co., Ltd. (Xinghua, CN). The FDA issued a Cleared decision on September 9, 2013 after a review of 420 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.

FDA 510(k) Submission Details - K122102

510(k) Number K122102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date September 09, 2013
Days to Decision 420 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
291d slower than avg
Panel avg: 129d · This submission: 420d
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 K122102.
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
K131828 · Jiangsu Handsafe Glove Co., Ltd. · Nov 2013
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
K131826 · Jiangsu Toptouch Glove Co., Ltd. · Nov 2013
BYTECH
K130101 · Bytech Dongtai Co., Ltd. · Nov 2013
POWDERED VINYL EXAMINATION GLOVES
K122100 · Wang Tong Xinghua Co., Ltd. · Aug 2013
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
K123590 · Weilin Plastic and Rubber Products Co., Ltd. · Jun 2013
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122396 · Wealth on (Jiangsu) Co., Ltd. · Jan 2013
K122102 · POWER FREE VINYL EXAMINATION GLOVES
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