Cleared Traditional

K964980 - ULTREX POWDER-FREE SURGICAL GLOVES/ULTR...

K964980 is an FDA 510(k) clearance for ULTREX POWDER-FREE SURGICAL GLOVES/ULTR..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K964980 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
83d
Days
Class 1
Risk

K964980 is an FDA 510(k) clearance for the ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LO.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Sugar Land, US). The FDA issued a Cleared decision on March 6, 1997 after a review of 83 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 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 Maxxim Medical devices

FDA 510(k) Submission Details - K964980

510(k) Number K964980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1996
Decision Date March 06, 1997
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K964980.
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
K964440 · Maxxim Medical · Apr 1997
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · Allegiance Healthcare Corp. · Mar 1997
SENTURA SURGICAL GLOVES
K964962 · Maxxim Medical · Mar 1997
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · Maxxim Medical · Jan 1997
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · Johnson & Johnson Medical, Inc. · Sep 1996
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
K961632 · Johnson & Johnson Medical, Inc. · Jul 1996