Cleared Abbreviated

K191860 - Sterile Powder-Free Synthetic Rubber Su...

K191860 is the FDA 510(k) clearance for Sterile Powder-Free Synthetic Rubber Su... by Semperit Technische Produkte Gesellchaft M.B.H.. It is a Class 1 General Hospital device (product code KGO) cleared through the Abbreviated 510(k) pathway after a 264-day FDA review.

K191860 · Semperit Technische Produkte Gesellchaft M.B.H. · General Hospital
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Mar 2020
Decision
264d
Days
Class 1
Risk

K191860 is an FDA 510(k) clearance for the Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Pote.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Semperit Technische Produkte Gesellchaft M.B.H. (Wimpassing, AT). The FDA issued a Cleared decision on March 31, 2020 after a review of 264 days - an extended review 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 Gesellchaft M.B.H. devices

Submission Details

510(k) Number K191860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2019
Decision Date March 31, 2020
Days to Decision 264 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
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 Consultant

Mansour Consulting, LLC
Jay Mansour

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGO Surgeon's Gloves

All 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K191860.
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