Cleared Traditional

K211310 - AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) (FDA 510(k) Clearance)

Class I General Hospital device.

K211310 · Megine Industries Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
47d
Days
Class 1
Risk

K211310 is an FDA 510(k) clearance for the AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Ora.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Megine Industries Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on June 16, 2021 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Megine Industries Sdn Bhd devices

Submission Details

510(k) Number K211310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date June 16, 2021
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1167
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