Cleared Traditional

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE (K990696) - FDA 510(k) Clearance

Class I General Hospital device.

K990696 · Omnigrace (Thailand) , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
71d
Days
Class 1
Risk

K990696 is an FDA 510(k) clearance for the OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Omnigrace (Thailand) , Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on May 13, 1999 after a review of 71 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 (Thailand) , Ltd. devices

Submission Details

510(k) Number K990696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1999
Decision Date May 13, 1999
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990696.
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · Medline Industries, Inc. · Oct 2008
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000