Cleared Abbreviated

K001343 - EUDERMIC PF POWDER-FREE SURGICAL GLOVES

K001343 is an FDA 510(k) clearance for EUDERMIC PF POWDER-FREE SURGICAL GLOVES, manufactured by Maxxim Medical, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 46-day FDA review.

K001343 · Maxxim Medical, Inc. · General Hospital
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Jun 2000
Decision
46d
Days
Class 1
Risk

K001343 is an FDA 510(k) clearance for the EUDERMIC PF POWDER-FREE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical, Inc. (Hone Path, US). The FDA issued a Cleared decision on June 12, 2000 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Maxxim Medical, Inc. devices

FDA 510(k) Submission Details - K001343

510(k) Number K001343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2000
Decision Date June 12, 2000
Days to Decision 46 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Standards-based clearance path.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 346
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K001343.
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · Ansell Perry · Jul 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K001959 · Hartalega Sdn Bhd · Jul 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · Terang Nusa Sdn Bhd · May 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K001239 · Ansell Perry · May 2000