Cleared Traditional

K980589 - AR SAFE NITRILE EXAMINATION GLOVES

K980589 is an FDA 510(k) clearance for AR SAFE NITRILE EXAMINATION GLOVES, manufactured by Alliance Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K980589 · Alliance Rubber Products Sdn. Bhd. · General Hospital
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Apr 1998
Decision
56d
Days
Class 1
Risk

K980589 is an FDA 510(k) clearance for the AR SAFE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Alliance Rubber Products Sdn. Bhd. (Pulau Pinang, MY). The FDA issued a Cleared decision on April 14, 1998 after a review of 56 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 Alliance Rubber Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K980589

510(k) Number K980589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date April 14, 1998
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K980589.
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981675 · Besglove Medicare Sdn. Bhd. · Jul 1998
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349 · Smart Glove Corp. Sdn Bhd · May 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981039 · Sri Johani Sdn. Bhd. · Apr 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · Smart Glove Corp. Sdn Bhd · Mar 1998
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