Cleared Traditional

K163017 - Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

K163017 is an FDA 510(k) clearance for Nitrile Blue Powder Free Examination Gl..., manufactured by Gmp Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K163017 · Gmp Medicare Sdn. Bhd. · General Hospital
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Mar 2017
Decision
145d
Days
Class 1
Risk

K163017 is an FDA 510(k) clearance for the Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Cla.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Gmp Medicare Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on March 22, 2017 after a review of 145 days - within the typical 510(k) review window.

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. devices

FDA 510(k) Submission Details - K163017

510(k) Number K163017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date March 22, 2017
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
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 68
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K163017.
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