Cleared Traditional

K093570 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR

K093570 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Jiangsu Jaysun Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K093570 · Jiangsu Jaysun Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
16d
Days
Class 1
Risk

K093570 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Jaysun Glove Co., Ltd. (Haidian Dis, Beijing, CN). The FDA issued a Cleared decision on December 4, 2009 after a review of 16 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.

FDA 510(k) Submission Details - K093570

510(k) Number K093570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2009
Decision Date December 04, 2009
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K093570.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093439 · Tangshan Pufa Plastic Products Co., Ltd. · Dec 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092966 · Jin Zhou Chang Hao Plastic Products Co., Ltd. · Dec 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092956 · Shandong Aobo Medical Co, Ltd. · Dec 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092820 · Shijiazhuang Fuhao Plastic Products Co., Ltd. · Dec 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093272 · Tangshan Huamei Healthcare Co., Ltd. · Nov 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093277 · Tangshan Green Healthcare Co., Ltd. · Nov 2009
K093570 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
Download PDF FDA Summary Jiangsu Jaysun Glove …