Cleared Traditional

K030228 - POWDERFREE POLYCHLOROPRENE STERILIZED S...

K030228 is the FDA 510(k) clearance for POWDERFREE POLYCHLOROPRENE STERILIZED S... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K030228 · Pt. Medisafe Technologies · General Hospital
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Mar 2003
Decision
51d
Days
Class 1
Risk

K030228 is an FDA 510(k) clearance for the POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, North Sumatra, ID). The FDA issued a Cleared decision on March 14, 2003 after a review of 51 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 Pt. Medisafe Technologies devices

Submission Details

510(k) Number K030228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2003
Decision Date March 14, 2003
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 146
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K030228.
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp. · Aug 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
K010862 · Allegiance Healthcare Corp. · Jun 2001