Cleared Traditional

K980419 - OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE

K980419 is an FDA 510(k) clearance for OMNI FLEX NITRILE EXAMINATION GLOVE, manufactured by Omnigrace (Thailand) , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K980419 · Omnigrace (Thailand) , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
38d
Days
Class 1
Risk

K980419 is an FDA 510(k) clearance for the OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Omnigrace (Thailand) , Ltd. (North Canton, US). The FDA issued a Cleared decision on March 13, 1998 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 (Thailand) , Ltd. devices

FDA 510(k) Submission Details - K980419

510(k) Number K980419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1998
Decision Date March 13, 1998
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 803
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K980419.
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K980275 · Besglove Medicare Sdn. Bhd. · Mar 1998
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K980280 · Besglove Medicare Sdn. Bhd. · Mar 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K980285 · Besglove Medicare Sdn. Bhd. · Mar 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
K980421 · Omnigrace (Thailand) , Ltd. · Mar 1998
NITRILE EXAMINATION GLOVES - POWDER FREE
K980511 · Influx Pacific Sdn. Bhd. · Mar 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710 · Sinochem Ningbo Latex Gloves Factory · Feb 1998