Cleared Traditional

K213289 - Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K213289 · Ansell Healthcare Products, LLC · General Hospital

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May 2023

Decision

602d

Days

Class 1

Risk

K213289 is an FDA 510(k) clearance for the Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Reno, US). The FDA issued a Cleared decision on May 26, 2023 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Ansell Healthcare Products, LLC devices

Submission Details

510(k) Number	K213289 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 01, 2021
Decision Date	May 26, 2023
Days to Decision	602 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

474d slower than avg

Panel avg: 128d · This submission: 602d

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.