Cleared Traditional

K024338 - POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE

K024338 is an FDA 510(k) clearance for POWDER FREE VINYL EXAM GLOVES WITH ALOE..., manufactured by General Gloves Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K024338 · General Gloves Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
66d
Days
Class 1
Risk

K024338 is an FDA 510(k) clearance for the POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by General Gloves Corp. (Tainan Hsien, TW). The FDA issued a Cleared decision on March 3, 2003 after a review of 66 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 - K024338

510(k) Number K024338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2002
Decision Date March 03, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K024338.
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
K030200 · Kaohsiung Brothers Products Corp. · Mar 2003
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
K030483 · Emerald Medical, Inc. · Mar 2003
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
K030484 · Emerald Medical, Inc. · Mar 2003
TOP GLOVE VINYL EXAMINATION GLOVE
K024216 · Top Glove (Zhangjiagang) Co. , Ltd. · Feb 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K030148 · Shanghai Palomar Mountain Industries, Inc. · Feb 2003
POWDERED VINYL EXAMINATION GLOVES
K024016 · Top Glove (Zhangjiagang) Co. , Ltd. · Feb 2003
K024338 · POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
Download PDF General Gloves Corp.