Cleared Traditional

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (K213437) - FDA 510(k) Clearance

Class I General Hospital device.

K213437 · Central Medicare Sdn Bhd · General Hospital
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Apr 2022
Decision
171d
Days
Class 1
Risk

K213437 is an FDA 510(k) clearance for the Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with C.... 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 April 11, 2022 after a review of 171 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 K213437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2021
Decision Date April 11, 2022
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
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 K213437.
Disposable Medical Nitrile Examination Gloves
K220561 · Nanjing Universal Medical Equipment Co., Ltd. · Apr 2022
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
Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
K220121 · Aamedix Glove 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