Cleared Traditional

K130473 - NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)

K130473 is an FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVE (..., 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 133-day FDA review.

K130473 · Hartalega Sdn Bhd · General Hospital
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Jul 2013
Decision
133d
Days
Class 1
Risk

K130473 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVE (ABLU). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Bestari Jaya, MY). The FDA issued a Cleared decision on July 5, 2013 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K130473

510(k) Number K130473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date July 05, 2013
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K130473.
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006 · Hartalega Sdn Bhd · Nov 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K131440 · Hebei Hongsen Plastics Technology Co, Ltd. · Sep 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
K130846 · Industrial Clothings, Ltd. · Aug 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
K122464 · Industrial Clothings, Ltd. · Apr 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K122453 · Industrial Clothings, Ltd. · Apr 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · Kossan Latex Industries(M)Sdn Bhd · Mar 2013