Cleared Traditional

K120934 - PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS

K120934 is an FDA 510(k) clearance for PROTEXIS LATEX BASIC STERILE LATEX POWD..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K120934 · Cardinal Health, Inc. · General Hospital
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May 2012
Decision
56d
Days
Class 1
Risk

K120934 is an FDA 510(k) clearance for the PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CO.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on May 23, 2012 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K120934

510(k) Number K120934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2012
Decision Date May 23, 2012
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

KGO Device Classification - Class 1, General Controls

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGO Surgeon's Gloves

All 368
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K120934.
STERILE LATEX SURGICAL GLOVE
K123628 · Lucenxia Prescience AG · Mar 2013
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
K121335 · Hutchinson Sante S.N.C. · Sep 2012
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · Cardinal Health, Inc. · Jul 2012
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · Cardinal Health-Medical Products and Services · Apr 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K113233 · Shen Wei (Usa), Inc. · Mar 2012
POWDERFREE POLYISOPRENE SURGICAL GLOVES
K112654 · Pt. Medisafe Technologies · Feb 2012

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.