Cleared Traditional

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (K213993) - FDA 510(k) Clearance

Class I General Hospital device.

K213993 · Careglove Global Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
227d
Days
Class 1
Risk

K213993 is an FDA 510(k) clearance for the Powder Free Chloroprene Examination Glove Coloured (Blue, Green). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Careglove Global Sdn. Bhd. (Seremban, MY). The FDA issued a Cleared decision on August 5, 2022 after a review of 227 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 Careglove Global Sdn. Bhd. devices

Submission Details

510(k) Number K213993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2021
Decision Date August 05, 2022
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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 K213993.
Nitrile Exam Gloves (Blue, Black)
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K213937 · O&M Halyard, Inc. · Aug 2022
Pro Guard Nitrile Powder Free Examination Glove
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K221350 · Rubberex Alliance Products Sdn Bhd · Aug 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929 · O&M Halyard, Inc. · Aug 2022
Disposable Medical Nitrile Examination Gloves
K220237 · Fujian Jixiang Medical Technology Co.,Ltd · Aug 2022