Cleared Traditional

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (K203036) - FDA 510(k) Clearance

Class I General Hospital device.

K203036 · Central Medicare Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
214d
Days
Class 1
Risk

K203036 is an FDA 510(k) clearance for the Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors). 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 7, 2021 after a review of 214 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 Central Medicare Sdn Bhd devices

Submission Details

510(k) Number K203036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2020
Decision Date May 07, 2021
Days to Decision 214 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
85d slower than avg
Panel avg: 129d · This submission: 214d
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 K203036.
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K210401 · Ansell Healthcare Products, LLC · Jun 2021
Nitrile Patient Examination Gloves
K211028 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jun 2021
Powder Free Nitrile Examination Glove
K210369 · Pastel Glove Sdn Bhd · May 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · Onetexx Sdn Bhd · May 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · Meditech Gloves Sdn Bhd · May 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
K210944 · Harbour Health, LLC · Apr 2021