Cleared Traditional

K050598 - POWDER FREE NITRILE EXAMINATION GLOVE W...

K050598 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE W..., manufactured by Smart Glove Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K050598 · Smart Glove Corp. Sdn Bhd · General Hospital
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Apr 2005
Decision
29d
Days
Class 1
Risk

K050598 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY D.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corp. Sdn Bhd (Klang Selangor, MY). The FDA issued a Cleared decision on April 7, 2005 after a review of 29 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 Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K050598

510(k) Number K050598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2005
Decision Date April 07, 2005
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 641
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K050598.
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · Hartalega Sdn Bhd · Jul 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · Kimberly-Clark Corp. · Jun 2005
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
K050122 · Smart Glove Corp. Sdn Bhd · Apr 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467 · Shen Wei (Usa), Inc. · Mar 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · Hartalega Sdn Bhd · Mar 2005
NITRILE POWDERED EXAMINATION GLOVES (WHITE)
K050215 · Hartalega Sdn Bhd · Mar 2005