Cleared Traditional

K050215 - NITRILE POWDERED EXAMINATION GLOVES (WHITE)

K050215 is an FDA 510(k) clearance for NITRILE POWDERED EXAMINATION GLOVES (WHITE), 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.

K050215 · Hartalega Sdn Bhd · General Hospital
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Mar 2005
Decision
39d
Days
Class 1
Risk

K050215 is an FDA 510(k) clearance for the NITRILE POWDERED EXAMINATION GLOVES (WHITE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Selangor, Darul Ehsan, MY). The FDA issued a Cleared decision on March 11, 2005 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 - K050215

510(k) Number K050215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2005
Decision Date March 11, 2005
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 907
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K050215.
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
K050598 · 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
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879 · Sgmp Co., Ltd. · Jan 2005
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
K041913 · Pt. Medisafe Technologies · Dec 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · Syntex Healthcare Products Co., Ltd. · Sep 2004