Cleared Traditional

K151390 - Powder Free Nitrile Examination Gloves ...

K151390 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Maxter Glove Manufacturing Sdn Bhd. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K151390 · Maxter Glove Manufacturing Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
342d
Days
Class 1
Risk

K151390 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Maxter Glove Manufacturing Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on May 2, 2016 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Maxter Glove Manufacturing Sdn Bhd devices

FDA 510(k) Submission Details - K151390

510(k) Number K151390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date May 02, 2016
Days to Decision 342 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 129d · This submission: 342d
Pathway characteristics
Predicate-based equivalence.

LZC Device Classification - Class 1, General Controls

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 52
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K151390.
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K172864 · Maxter Glove Manufacturing Sdn Bhd · May 2018
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K173942 · Central Medicare Sdn Bhd · Mar 2018
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
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K141982 · Wrp Asia Pacific Sdn. Bhd. · Feb 2015
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K120336 · Hartalega Sdn Bhd · Jun 2012