Cleared Traditional

K213373 - Powder-Free Green Biodegradable Nitrile...

K213373 is an FDA 510(k) clearance for Powder-Free Green Biodegradable Nitrile..., manufactured by Smart Glove Corporation Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K213373 · Smart Glove Corporation Sdn. Bhd. · General Hospital
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Mar 2022
Decision
149d
Days
Class 1
Risk

K213373 is an FDA 510(k) clearance for the Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corporation Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on March 10, 2022 after a review of 149 days - within the typical 510(k) review window.

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 Smart Glove Corporation Sdn. Bhd. devices

FDA 510(k) Submission Details - K213373

510(k) Number K213373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2021
Decision Date March 10, 2022
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 684
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