Cleared Traditional

K200581 - Biodegradable Nitrile Powder Free Exami...

K200581 is the FDA 510(k) clearance for Biodegradable Nitrile Powder Free Exami... by Hartalega NGC Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K200581 · Hartalega NGC Sdn. Bhd. · General Hospital
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Apr 2020
Decision
51d
Days
Class 1
Risk

K200581 is an FDA 510(k) clearance for the Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chem.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on April 25, 2020 after a review of 51 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 NGC Sdn. Bhd. devices

Submission Details

510(k) Number K200581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2020
Decision Date April 25, 2020
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K200581.
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K200453 · Yty Industry (Manjung) Sdn Bhd · May 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K200181 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 2020
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K200072 · Kimberly Clark Corporation · Apr 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · Riverstone Resources Sdn Bhd · Apr 2020