Cleared Traditional

K152222 - NITRILE BLUE POWDER FREE EXAMINATION GL...

K152222 is the FDA 510(k) clearance for NITRILE BLUE POWDER FREE EXAMINATION GL... by Gmp Medicare Sdn Bhd (F25). It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K152222 · Gmp Medicare Sdn Bhd (F25) · General Hospital
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Apr 2016
Decision
258d
Days
Class 1
Risk

K152222 is an FDA 510(k) clearance for the NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Gmp Medicare Sdn Bhd (F25) (Klang, MY). The FDA issued a Cleared decision on April 21, 2016 after a review of 258 days - an extended review 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: 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 Gmp Medicare Sdn Bhd (F25) devices

Submission Details

510(k) Number K152222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date April 21, 2016
Days to Decision 258 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 129d · This submission: 258d
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 41
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K152222.
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K173942 · Central Medicare Sdn Bhd · Mar 2018
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K141982 · Wrp Asia Pacific Sdn. Bhd. · Feb 2015
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
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NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
K120336 · Hartalega Sdn Bhd · Jun 2012