Cleared Traditional

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) (K182043) - FDA 510(k) Clearance

Class I General Hospital device.

K182043 · Hebei Titans Hongsen Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
53d
Days
Class 1
Risk

K182043 is an FDA 510(k) clearance for the Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hebei Titans Hongsen Medical Technology Co., Ltd. (Nangong, CN). The FDA issued a Cleared decision on September 21, 2018 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hebei Titans Hongsen Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K182043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date September 21, 2018
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 K182043.
Powder Free Vinyl Patient Examination Gloves
K180381 · Shanxi Hongjin Plastic Technology Co., Ltd. · Nov 2018
Vinyl Patient Examination Gloves
K182117 · Jiangxi Zhonghong Pulin Medical Products Co., Ltd. · Oct 2018
Vinyl Patient Examination Gloves
K182115 · Pingan Medical Products Co., Ltd. · Oct 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180861 · Zhicheng Trading Co., Ltd. · Jun 2018
Powder Free Vinyl Patient Examination Gloves (Yellow, White)
K180260 · Shanxi Hongjin Plastic Technology Co., Ltd. · Jun 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180849 · Huifu Trading Co., Ltd. · Jun 2018