Cleared Traditional

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181) - FDA 510(k) Clearance

Class I General Hospital device.

K222181 · Iconic Medicare Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
173d
Days
Class 1
Risk

K222181 is an FDA 510(k) clearance for the Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Iconic Medicare Sdn Bhd (Bandar Cassia, Pulau Pinang., MY). The FDA issued a Cleared decision on January 11, 2023 after a review of 173 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 Iconic Medicare Sdn Bhd devices

Submission Details

510(k) Number K222181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2022
Decision Date January 11, 2023
Days to Decision 173 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 129d · This submission: 173d
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 Consultant

Integrated Assessment Services Pvt, Ltd.
A.C. Thirumaran

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K222181.
Disposable Nitrile Examination Glove
K223250 · Yangzhou Saraguard Medical Supplies Co., Ltd. · Jan 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · Dynacare Sdn Bhd · Jan 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · Us Medical Glove Company, LLC · Jan 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K222907 · Rmkh Glove (Cambodia) Co., Ltd. · Jan 2023
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
K222892 · Grand Work Plastic Products Co., Ltd. · Dec 2022
Nitrile Patient Examination Glove
K222527 · Pingan Medical Products Co., Ltd. · Dec 2022