Cleared Traditional

K991981 - NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR

K991981 is an FDA 510(k) clearance for 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 52-day FDA review.

K991981 · Alliance Rubber Products Sdn. Bhd. · General Hospital
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Aug 1999
Decision
52d
Days
Class 1
Risk

K991981 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR. 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 August 5, 1999 after a review of 52 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 - K991981

510(k) Number K991981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date August 05, 1999
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K991981.
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497 · Kossan Latex Industries(M)Sdn Bhd · Aug 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · Pamitex Industries Sdn Bhd · Aug 1999
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
K990883 · La Glove (M) Sdn. Bhd. · Aug 1999
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
K991615 · Maxxim Medical · Jul 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · Brightway Holdings Sdn. Bhd. · Jun 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
K991744 · Shield Gloves Manufacturer (M) Sdn Bhd · Jun 1999