Cleared Traditional

K230564 - Green Non Sterile Powder Free Nitrile Examination Gloves

K230564 is an FDA 510(k) clearance for Green Non Sterile Powder Free Nitrile E..., manufactured by Central Medicare Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

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

FDA 510(k) Submission Details - K230564

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.

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 1142
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