Cleared Traditional

K041391 - FREEFORM BLUE POWDER-FREE NITRILE EXAMI...

K041391 is the FDA 510(k) clearance for FREEFORM BLUE POWDER-FREE NITRILE EXAMI... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K041391 · Hartalega Sdn Bhd · General Hospital
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Jul 2004
Decision
45d
Days
Class 1
Risk

K041391 is an FDA 510(k) clearance for the FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Reno, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 45 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

Submission Details

510(k) Number K041391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date July 09, 2004
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 554
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K041391.
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
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc. · Oct 2003
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · Hartalega Sdn Bhd · Nov 2002