Cleared Traditional

K122377 - POWDER FREE VINYL EXAMINATION GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

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.

View all Shu Tong Xinghua Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
498d slower than avg
Panel avg: 129d · This submission: 627d
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 K122377.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · Basic Medical Technology, Inc. · Apr 2026
Disposable Vinyl Examination Gloves
K252467 · Viet Phu Trade and Import Export Co., Ltd. · Oct 2025
Powder-Free Vinyl Exam Gloves, clear
K252505 · Basic Medical Technology, Inc. · Aug 2025
Disposable Vinyl Examination Gloves
K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
Vinyl examination gloves
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