Cleared Traditional

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. (K211022) - FDA 510(k) Clearance

Class I General Hospital device.

K211022 · Central Medicare Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
261d
Days
Class 1
Risk

K211022 is an FDA 510(k) clearance for the Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with .... 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 December 22, 2021 after a review of 261 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 K211022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2021
Decision Date December 22, 2021
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
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 K211022.
ATM Glove
K213016 · Phu Duc Huy Production Trading Services Corporation · Dec 2021
Dermoaroma Disposable Nitrile Examination Glove
K212716 · Chuzhou Harmony Gloves Medical Technology Co.,Ltd · Dec 2021
Nitrile Examination Golves Powder Free
K212921 · Jiangsu Standard Health Co.,Ltd · Dec 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · Glovmaster Sdn. Bhd. · Dec 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
K212613 · Koon Seng Sdn Bhd · Dec 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457 · Ammex Corporation · Dec 2021