Cleared Traditional

K964563 - OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE

K964563 is an FDA 510(k) clearance for OMNI GRIP LATEX EXAMINATION GLOVE, manufactured by Omni Sales Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K964563 · Omni Sales Corp. · General Hospital
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Dec 1996
Decision
46d
Days
Class 1
Risk

K964563 is an FDA 510(k) clearance for the OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Omni Sales Corp. (Canton, US). The FDA issued a Cleared decision on December 30, 1996 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 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 - K964563

510(k) Number K964563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date December 30, 1996
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 1326
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K964563.
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES
K964317 · Nantong Ruchang Latex Products Co., Ltd. · Jan 1997
DERLIN
K964817 · Derlin Company , Ltd. · Jan 1997
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · Dash Medical Gloves Sdn Bhd · Dec 1996
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
K963211 · American Healthcare Products, Inc. · Nov 1996
FLAVORED LATEX PATIENT EXAMINATION
K960315 · P.T. Irama Dinamika Latex · Nov 1996
LATEX EXAMINATION GLOVES, POWDERED
K963742 · Arista Medi Prima · Nov 1996
K964563 · OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
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