Cleared Traditional

Vinyl Patient Examination Gloves (K182117) - FDA 510(k) Clearance

Class I General Hospital device.

K182117 · Jiangxi Zhonghong Pulin Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
61d
Days
Class 1
Risk

K182117 is an FDA 510(k) clearance for the Vinyl Patient Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangxi Zhonghong Pulin Medical Products Co., Ltd. (Jiu Jiang, CN). The FDA issued a Cleared decision on October 6, 2018 after a review of 61 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 Jiangxi Zhonghong Pulin Medical Products Co., Ltd. devices

Submission Details

510(k) Number K182117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date October 06, 2018
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle 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 K182117.
Powder-Free Clear Vinyl Patient Examination Gloves
K190095 · Anhui Intco Medical Products Co., Ltd. · Jun 2019
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K182575 · Jiangxi Jaysun Medcare Co., Ltd. · May 2019
Powder Free Vinyl Patient Examination Gloves
K180381 · Shanxi Hongjin Plastic Technology Co., Ltd. · Nov 2018
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