Cleared Traditional

K171375 - Gammex PI Breach Detect Powder Free Surgical Glove (FDA 510(k) Clearance)

Class I General Hospital device.

K171375 · Ansell Healthcare Products, LLC · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Feb 2018

Decision

272d

Days

Class 1

Risk

K171375 is an FDA 510(k) clearance for the Gammex PI Breach Detect Powder Free Surgical Glove. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Iselin, US). The FDA issued a Cleared decision on February 6, 2018 after a review of 272 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Ansell Healthcare Products, LLC devices

Submission Details

510(k) Number	K171375 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 10, 2017
Decision Date	February 06, 2018
Days to Decision	272 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

144d slower than avg

Panel avg: 128d · This submission: 272d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KGO Surgeon's Gloves
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 878.4460
Definition	A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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.