Cleared Traditional

K182575 - Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (FDA 510(k) Clearance)

Class I General Hospital device.

K182575 · Jiangxi Jaysun Medcare Co., Ltd. · General Hospital
May 2019
Decision
247d
Days
Class 1
Risk

K182575 is an FDA 510(k) clearance for the Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangxi Jaysun Medcare Co., Ltd. (Jiujiang, CN). The FDA issued a Cleared decision on May 24, 2019 after a review of 247 days — an extended review 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: 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.

Submission Details

510(k) Number K182575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2018
Decision Date May 24, 2019
Days to Decision 247 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 169d · This submission: 247d
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.