Cleared Traditional

K984064 - OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

K984064 is an FDA 510(k) clearance for OMNIGRIP, manufactured by Omni Intl., Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K984064 · Omni Intl., Inc. · General Hospital
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Jan 1999
Decision
53d
Days
Class 1
Risk

K984064 is an FDA 510(k) clearance for the OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Omni Intl., Inc. (Canton, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 53 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 Omni Intl., Inc. devices

FDA 510(k) Submission Details - K984064

510(k) Number K984064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 08, 1999
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 294
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K984064.
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · Terang Nusa Sdn Bhd · Jan 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
K984066 · Omni Intl., Inc. · Jan 1999
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · Cardinal Health-Medical Products and Services · Jan 1999
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
K983240 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
SEMPERMED SURGEONS' GLOVES - SUPREME
K981096 · Semperit Technische Produkte Gesellshaft · Oct 1998