Cleared Traditional

K993419 - OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE

Also marketed or referenced as:
POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)

K993419 is an FDA 510(k) clearance for OMNIGRACE LATEX EXAMINATION GLOVE, manufactured by Omnigrace , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K993419 · Omnigrace , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1999
Decision
38d
Days
Class 1
Risk

K993419 is an FDA 510(k) clearance for the OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Omnigrace , Ltd. (North Canton, US). The FDA issued a Cleared decision on November 19, 1999 after a review of 38 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.

View all Omnigrace , Ltd. devices

FDA 510(k) Submission Details - K993419

510(k) Number K993419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date November 19, 1999
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 445
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K993419.
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
K993502 · Besglove Medicare Sdn. Bhd. · Nov 1999
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
K993722 · Hartalega Sdn Bhd · Nov 1999
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
K993725 · Hartalega Sdn Bhd · Nov 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · Sri Johani Sdn. Bhd. · Nov 1999
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K993093 · Pamitex Industries Sdn Bhd · Oct 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM
K993097 · Pamitex Industries Sdn Bhd · Oct 1999