Cleared Abbreviated

SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 (K012819) - FDA 510(k) Clearance

Class I General Hospital device.

K012819 · Semperit Technische Produkte Gesellshaft · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
85d
Days
Class 1
Risk

K012819 is an FDA 510(k) clearance for the SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Semperit Technische Produkte Gesellshaft (Apharetta, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 85 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Semperit Technische Produkte Gesellshaft devices

Submission Details

510(k) Number K012819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date November 16, 2001
Days to Decision 85 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K012819.
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · Baxter Healthcare Corp · Jul 1994
SURESOFT SURGICAL GLOVES
K940218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
K935869 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994