Cleared Traditional

K122377 - POWDER FREE VINYL EXAMINATION GLOVES

K122377 is an FDA 510(k) clearance for POWDER FREE VINYL EXAMINATION GLOVES, manufactured by Shu 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 627-day FDA review.

K122377 · Shu Tong Xinghua Co., Ltd. · General Hospital
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Apr 2014
Decision
627d
Days
Class 1
Risk

K122377 is an FDA 510(k) clearance for the POWDER FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shu Tong Xinghua Co., Ltd. (Xinghua, CN). The FDA issued a Cleared decision on April 11, 2014 after a review of 627 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 - K122377

510(k) Number K122377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date April 11, 2014
Days to Decision 627 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
498d slower than avg
Panel avg: 129d · This submission: 627d
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 742
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K122377.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K122656 · Shandong Yifan Plastic Products Co., Ltd. · May 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K132637 · Zibo Intco Medical Products Co., Ltd. · May 2014
POWDERED VINYL EXAMINATION GLOVES
K122176 · Shu Tong Xinghua Co., Ltd. · Apr 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130751 · Cabin Plastic Co., Ltd. · Mar 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130800 · Kaixuan Plastic Co., Ltd. · Feb 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130809 · Jewel Plastic Co., Ltd. · Feb 2014
K122377 · POWDER FREE VINYL EXAMINATION GLOVES
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