Cleared Traditional

K163146 - POWDER FREE Blue Nitrile GLOVES

K163146 is an FDA 510(k) clearance for POWDER FREE Blue Nitrile GLOVES, manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K163146 · Hebei Hongsen Plastics Technology Co, Ltd. · General Hospital
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Feb 2017
Decision
96d
Days
Class 1
Risk

K163146 is an FDA 510(k) clearance for the POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Hebei Hongsen Plastics Technology Co, Ltd. (Nangong, CN). The FDA issued a Cleared decision on February 13, 2017 after a review of 96 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 Hebei Hongsen Plastics Technology Co, Ltd. devices

FDA 510(k) Submission Details - K163146

510(k) Number K163146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2016
Decision Date February 13, 2017
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
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 52
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K163146.
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