Cleared Traditional

Green Non Sterile Powder Free Nitrile Examination Gloves (K230564) - FDA 510(k) Clearance

Class I General Hospital device.

K230564 · Central Medicare Sdn Bhd · General Hospital
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May 2023
Decision
83d
Days
Class 1
Risk

K230564 is an FDA 510(k) clearance for the Green Non Sterile Powder Free Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Central Medicare Sdn Bhd (Teluk Intan, MY). The FDA issued a Cleared decision on May 23, 2023 after a review of 83 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 Central Medicare Sdn Bhd devices

Submission Details

510(k) Number K230564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2023
Decision Date May 23, 2023
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K230564.
Disposable Nitrile Gloves (ABC-DG01)
K230542 · Huizhou Anboson Technology Co., Ltd. · May 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958 · First Glove Sdn. Bhd. · May 2023
Blue Nitrile Examination Gloves Powder Free
K230601 · Latrile Gloves Private Limited · May 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
K223437 · Hartalega NGC Sdn. Bhd. · May 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K230121 · Careglove Global Sdn. Bhd. · May 2023
Disposible Nitrile Gloves
K223280 · Holik Asia Group Co.,Ltd · May 2023