Cleared Traditional

K024081 - DISPOSBLE POWDER FREE VINYL SYNTHETIC E...

K024081 is an FDA 510(k) clearance for DISPOSBLE POWDER FREE VINYL SYNTHETIC E..., manufactured by Safehealth Medical Supply Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K024081 · Safehealth Medical Supply Corp. · General Hospital
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Jan 2003
Decision
48d
Days
Class 1
Risk

K024081 is an FDA 510(k) clearance for the DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Safehealth Medical Supply Corp. (Tainan Hsien, TW). The FDA issued a Cleared decision on January 28, 2003 after a review of 48 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 Safehealth Medical Supply Corp. devices

FDA 510(k) Submission Details - K024081

510(k) Number K024081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2002
Decision Date January 28, 2003
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 101
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K024081.
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc. · Oct 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · Allegiance Healthcare Corp. · May 2001
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000