Cleared Traditional

K160562 - Nitrile Powder Free Examination Glove w...

K160562 is an FDA 510(k) clearance for Nitrile Powder Free Examination Glove w..., manufactured by Hartalega Snd. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K160562 · Hartalega Snd. Bhd. · General Hospital
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Oct 2016
Decision
227d
Days
Class 1
Risk

K160562 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for U.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Snd. Bhd. (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on October 13, 2016 after a review of 227 days - an extended review 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: 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 Snd. Bhd. devices

FDA 510(k) Submission Details - K160562

510(k) Number K160562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date October 13, 2016
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 744
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K160562.
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
K162095 · Yty Industry (Manjung) Sdn Bhd · Nov 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422 · Wrp Asia Pacific Sdn. Bhd. · Oct 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473 · Medline Industries, Inc. · Oct 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560 · Hartalega Sdn Bhd · Aug 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · Hartalega NGC Sdn. Bhd. · Mar 2016
Powder Free Polychloroprene Examination Glove Green
K153510 · Terang Nusa Sdn Bhd · Mar 2016