Cleared Traditional

K151390 - Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K151390 · Maxter Glove Manufacturing Sdn Bhd · General Hospital
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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

Submission Details

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
214d slower than avg
Panel avg: 128d · This submission: 342d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 78
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K151390.
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · Cardinalhealth · Jan 2026
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
K243959 · Lingshi Hongruida Health Protection Technology Co., Ltd. · Feb 2025
JR Medic
K221157 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Aug 2022
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
K222449 · Better Care Plastic Technology Co., Ltd. · Aug 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
K220545 · Hl Rubber Industries Sdn Bhd · May 2022
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K220491 · Hainan Asther Medical Equipment Co., Ltd. · May 2022