Cleared Traditional Expedited

K990283 - BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

K990283 is an FDA 510(k) clearance for BLUE POWDER-FREE NITRILE EXAMINATION GLOVES, manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K990283 · Hartalega Sdn Bhd · General Hospital
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Mar 1999
Decision
39d
Days
Class 1
Risk

K990283 is an FDA 510(k) clearance for the BLUE POWDER-FREE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on March 9, 1999 after a review of 39 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 Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K990283

510(k) Number K990283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date March 09, 1999
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 908
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990283.
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415 · La Glove (M) Sdn. Bhd. · Mar 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420 · La Glove (M) Sdn. Bhd. · Mar 1999
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES
K990013 · Yty Industry (Manjung) Sdn Bhd · Mar 1999
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K990453 · Alliance Rubber Products Sdn. Bhd. · Mar 1999
NITRILE POWDER FREE EXAMINATION GLOVES
K983334 · Cranberry (M) Sdn. Bhd. · Feb 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615 · Shiva Medicare , Ltd. · Feb 1999