Cleared Traditional

K210401 - Microflex Nitrile Patient Examination G...

K210401 is the FDA 510(k) clearance for Microflex Nitrile Patient Examination G... by Ansell Healthcare Products, LLC. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K210401 · Ansell Healthcare Products, LLC · General Hospital
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Jun 2021
Decision
123d
Days
Class 1
Risk

K210401 is an FDA 510(k) clearance for the Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Reno, US). The FDA issued a Cleared decision on June 13, 2021 after a review of 123 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 Ansell Healthcare Products, LLC devices

Submission Details

510(k) Number K210401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2021
Decision Date June 13, 2021
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K210401.
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
K202085 · Shen Wei (Usa), Inc. · Jun 2021
Powder Free Blue Nitrile Examination Glove
K210375 · Duramitt Sdn Bhd · Jun 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
K211310 · Megine Industries Sdn Bhd · Jun 2021
Nitrile Patient Examination Gloves
K211028 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jun 2021
Powder Free Nitrile Examination Glove
K210369 · Pastel Glove Sdn Bhd · May 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · Central Medicare Sdn Bhd · May 2021