Cleared Traditional

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves (K212349) - FDA 510(k) Clearance

Class I General Hospital device.

K212349 · Medi Legion Sdn.Bhd · General Hospital
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Dec 2021
Decision
135d
Days
Class 1
Risk

K212349 is an FDA 510(k) clearance for the Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gl.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medi Legion Sdn.Bhd (Kuala Langat, MY). The FDA issued a Cleared decision on December 10, 2021 after a review of 135 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 Medi Legion Sdn.Bhd devices

Submission Details

510(k) Number K212349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2021
Decision Date December 10, 2021
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 K212349.
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K213371 · Anhui Xinyisheng Medical Technology Co.,Ltd · Dec 2021