Cleared Traditional

K162858 - NITRILECARE NITRILE EXAMINATION GLOVES ...

K162858 is an FDA 510(k) clearance for NITRILECARE NITRILE EXAMINATION GLOVES ..., manufactured by Careplus (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 285-day FDA review.

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.

View all Careplus (M) Sdn Bhd devices

FDA 510(k) Submission Details - K162858

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
156d slower than avg
Panel avg: 129d · This submission: 285d
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 51
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K162858.
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · Comfort Rubber Gloves Industries Sdn. Bhd. · May 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K172864 · Maxter Glove Manufacturing Sdn Bhd · May 2018
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K173942 · Central Medicare Sdn Bhd · Mar 2018
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
K162186 · Brightway Holdings Sdn. Bhd. · Mar 2017
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
K121811 · Shen Wei (Usa), Inc. · Nov 2012