Cleared Traditional

K023236 - SENSICARE -C SYNTHETIC POLYISOPRENE POW...

K023236 is an FDA 510(k) clearance for SENSICARE -C SYNTHETIC POLYISOPRENE POW..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K023236 · Maxxim Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
46d
Days
Class 1
Risk

K023236 is an FDA 510(k) clearance for the SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Hone Path, US). The FDA issued a Cleared decision on November 12, 2002 after a review of 46 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 Maxxim Medical devices

FDA 510(k) Submission Details - K023236

510(k) Number K023236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date November 12, 2002
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K023236.
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · Cardinalhealth · Oct 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)
K022442 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K021784 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002