Cleared Traditional

Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black (K220121) - FDA 510(k) Clearance

Class I General Hospital device.

K220121 · Aamedix Glove Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
83d
Days
Class 1
Risk

K220121 is an FDA 510(k) clearance for the Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Aamedix Glove Sdn Bhd (Selanger Darul Ehsan, MY). The FDA issued a Cleared decision on April 11, 2022 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 Aamedix Glove Sdn Bhd devices

Submission Details

510(k) Number K220121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date April 11, 2022
Days to Decision 83 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
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 K220121.
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
K220373 · Summit Glove, Inc. · Apr 2022
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
K220375 · Summit Glove, Inc. · Apr 2022
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
K213437 · Central Medicare Sdn Bhd · Apr 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
K220209 · Ksg Medicare Sdn. Bhd. · Apr 2022
Nitrile Examination Gloves
K212929 · Watchtower Ppe Supplies, Inc. · Apr 2022
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
K220401 · Riverstone Resources Sdn Bhd · Apr 2022