Cleared Traditional

K162858 - NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST (FDA 510(k) Clearance)

Class I General Hospital device.

K162858 · Careplus (M) Sdn Bhd · General Hospital

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Jul 2017

Decision

285d

Days

Class 1

Risk

K162858 is an FDA 510(k) clearance for the NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on July 24, 2017 after a review of 285 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.

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Submission Details

510(k) Number	K162858 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 12, 2016
Decision Date	July 24, 2017
Days to Decision	285 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

157d slower than avg

Panel avg: 128d · This submission: 285d

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 Surgeons) 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.