Cleared Traditional

K201592 - Cardinal Health Protexis PI Blue with N...

K201592 is the FDA 510(k) clearance for Cardinal Health Protexis PI Blue with N... by Cardinal Health200, LLC. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 471-day FDA review.

K201592 · Cardinal Health200, LLC · General Hospital
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Sep 2021
Decision
471d
Days
Class 1
Risk

K201592 is an FDA 510(k) clearance for the Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on September 26, 2021 after a review of 471 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 Cardinal Health200, LLC devices

Submission Details

510(k) Number K201592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2020
Decision Date September 26, 2021
Days to Decision 471 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
342d slower than avg
Panel avg: 129d · This submission: 471d
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 K201592.
Sterile Latex Surgical Gloves Powder Free
K212848 · Pentavest Holdings Sdn Bhd · Dec 2021
Nulife
K210969 · Mrk Healthcare Pvt, Ltd. · Nov 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
K211621 · Careplus (M) Sdn Bhd · Oct 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · Aspen Glove Sdn. Bhd. · Sep 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
K210724 · Careplus (M) Sdn Bhd · Aug 2021
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
K203538 · Medline Industries, Inc. · Aug 2021