Cleared Traditional

K030483 - SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

K030483 · Emerald Medical, Inc. · General Hospital
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Mar 2003
Decision
20d
Days
Class 1
Risk

K030483 is an FDA 510(k) clearance for the SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Emerald Medical, Inc. (Great Neck, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 20 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 Emerald Medical, Inc. devices

Submission Details

510(k) Number K030483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2003
Decision Date March 06, 2003
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
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 Peers - LYZ Vinyl Patient Examination Glove

All 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K030483.
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Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · Ever Global (Vietnam) Enterprise Corporation · Feb 2023