Cleared Traditional

K212349 - Powder Free

K212349 is an FDA 510(k) clearance for Powder Free, manufactured by Medi Legion Sdn.Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K212349

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.

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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K212349.
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085 · Siam Ntd Corporation Co., Ltd. · Dec 2021
Iconic Nitrile Glove
K212182 · Iconic Medicare Sdn Bhd · Dec 2021
Nitrile Gloves (Model: NE01)
K212840 · Byd Auto Industry Company Limited · Dec 2021
ComfortPro Blue Nitrile Examination Gloves Powder Free
K212850 · Thai Rubber Industry Company Limited · Dec 2021
Nitrile Examination Gloves
K212922 · Hsk Medical Apparatus Foshan China Co., Ltd. · Dec 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · Anhui Xinyisheng Medical Technology Co.,Ltd · Dec 2021