Cleared Traditional

K033905 - PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING

K033905 is an FDA 510(k) clearance for PROTEGRITY STEILE LATEX SURGICAL GLOVES..., manufactured by Cardinalhealth. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K033905 · Cardinalhealth · General Hospital
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Apr 2004
Decision
132d
Days
Class 1
Risk

K033905 is an FDA 510(k) clearance for the PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 132 days - within the typical 510(k) review window.

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 Cardinalhealth devices

FDA 510(k) Submission Details - K033905

510(k) Number K033905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2003
Decision Date April 27, 2004
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

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 Peers - KGO Surgeon's Gloves

All 351
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K033905.
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
K042574 · Cardinalhealth · Dec 2004
MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE
K041437 · Terang Nusa Sdn Bhd · Sep 2004
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
K041436 · Terang Nusa Sdn Bhd · Aug 2004
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
K040503 · Wrp Asia Pacific Sdn. Bhd. · Mar 2004
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · Wrp Asia Pacific Sdn. Bhd. · Dec 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd. · Nov 2003