Cleared Traditional

K200581 - Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

K200581 is an FDA 510(k) clearance for Biodegradable Nitrile Powder Free Exami..., manufactured by Hartalega NGC Sdn. Bhd.. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K200581

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.

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 1010
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K200581.
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967 · Mercator Medical (Thailand), Ltd. · Jun 2020
Latex Examination Powder Free Glove, Aloe Vera
K193150 · Top Glove Sdn. Bhd. · Jun 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
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
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
K200072 · Kimberly Clark Corporation · Apr 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · Riverstone Resources Sdn Bhd · Apr 2020