Cleared Abbreviated

K012819 - SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9

K012819 is an FDA 510(k) clearance for SEMPERMED DERMA PLUS, manufactured by Semperit Technische Produkte Gesellshaft. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K012819 · Semperit Technische Produkte Gesellshaft · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K012819

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 495
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K012819.
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · Smart Glove Corp. Sdn Bhd · Dec 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
K013324 · Tillotson Healthcare Corp. · Nov 2001
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
K012880 · Ssn Gloves (M) Sdn Bhd · Nov 2001
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
K012896 · Ssn Gloves (M) Sdn Bhd · Nov 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
K013603 · Ansell Healthcare Products, Inc. · Nov 2001
K012819 · SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
Download PDF FDA Summary Semperit Technische P…