Cleared Traditional

K180260 - Powder Free Vinyl Patient Examination Gloves (Yellow, White) (FDA 510(k) Clearance)

Class I General Hospital device.

K180260 · Shanxi Hongjin Plastic Technology Co., Ltd. · General Hospital
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Jun 2018
Decision
133d
Days
Class 1
Risk

K180260 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves (Yellow, White). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanxi Hongjin Plastic Technology Co., Ltd. (Linfen City, CN). The FDA issued a Cleared decision on June 12, 2018 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanxi Hongjin Plastic Technology Co., Ltd. devices

Submission Details

510(k) Number K180260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date June 12, 2018
Days to Decision 133 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
5d slower than avg
Panel avg: 128d · This submission: 133d
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 K180260.
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