Cleared Traditional

K213289 - Gammex PI Plus Glove-in-Glove System Te...

K213289 is the FDA 510(k) clearance for Gammex PI Plus Glove-in-Glove System Te... by Ansell Healthcare Products, LLC. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 602-day FDA review.

K213289 · Ansell Healthcare Products, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
473d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K213289.
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs
K222993 · Sentienx Sdn Bhd · Aug 2023
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
K230832 · The Egyptian Company For Medical & Electronic Industries · Aug 2023
Polyisoprene Surgical Gloves
K230304 · Puyang Linshi Medical Supplies Co., Ltd. · Aug 2023
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
K230217 · Grand Work Plastic Products Co., Ltd. · May 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Apr 2023
Sterilized Latex Surgical Gloves
K222620 · Suzhou Colour-Way New Material Co., Ltd. · Mar 2023