Cleared Traditional

K983725 - OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE

K983725 is an FDA 510(k) clearance for OMNI TOUCH NITRILE EXAMINATION GLOVE, manufactured by Omnigrace , Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K983725 · Omnigrace , Ltd. · General Hospital
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Dec 1998
Decision
46d
Days
Class 1
Risk

K983725 is an FDA 510(k) clearance for the OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Omnigrace , Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on December 7, 1998 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.

View all Omnigrace , Ltd. devices

FDA 510(k) Submission Details - K983725

510(k) Number K983725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date December 07, 1998
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 779
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K983725.
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356 · Perusahaan Getah Asas Sdn. Bhd. · Jan 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1998
NITRILE LATEX POWDERED EXAMINATION GLOVE
K983816 · Top Glove Sdn. Bhd. · Dec 1998
NITRILE LATEX POWDER FREE EXAMINATION GLOVE
K983825 · Top Glove Sdn. Bhd. · Dec 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998