Cleared Traditional

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

Class I General Hospital device.

K180260 · Shanxi Hongjin Plastic Technology Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · 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 Consultant

Hongray USA Medical Products, Inc.
Kathy Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K180260.
Vinyl Patient Examination Gloves
K182115 · Pingan Medical Products Co., Ltd. · Oct 2018
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
K182043 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Sep 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180861 · Zhicheng Trading Co., Ltd. · Jun 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180849 · Huifu Trading Co., Ltd. · Jun 2018
Powder-free Clear Vinyl Patient Examination Gloves
K173078 · Yongsheng Medical Products Co., Ltd. · Mar 2018
Vinyl Patient Examination Glove (Yellow)
K173580 · Nature Medical Products Co., Ltd. · Feb 2018