Cleared Traditional

K982131 - NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

K982131 is an FDA 510(k) clearance for NITRA-TOUCH POWDER-FREE NITRILE MEDICAL..., manufactured by Ansell Edmont Industrial, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K982131 · Ansell Edmont Industrial, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
134d
Days
Class 1
Risk

K982131 is an FDA 510(k) clearance for the NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ansell Edmont Industrial, Inc. (Coshocton, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ansell Edmont Industrial, Inc. devices

FDA 510(k) Submission Details - K982131

510(k) Number K982131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date October 29, 1998
Days to Decision 134 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 129d · This submission: 134d
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 K982131.
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
NITRILE POWDERFREE EXAMINATION GLOVES
K981877 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981878 · Besglove Medicare Sdn. Bhd. · Aug 1998