Cleared Traditional

K193573 - Biogel Skinsense Indicator Underglove

K193573 is the FDA 510(k) clearance for Biogel Skinsense Indicator Underglove by Molnlycke Health Care Us, LLC. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K193573 · Molnlycke Health Care Us, LLC · General Hospital
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Apr 2020
Decision
109d
Days
Class 1
Risk

K193573 is an FDA 510(k) clearance for the Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indica.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on April 10, 2020 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Molnlycke Health Care Us, LLC devices

Submission Details

510(k) Number K193573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date April 10, 2020
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K193573.
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
K201774 · Pt. Medisafe Technologies · Sep 2020
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
K201829 · Medline Industries, Inc. · Sep 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
K200897 · Hartalega Sdn Bhd · Jun 2020
SensiCare PI and SensiCare PI Micro Surgical Gloves
K193217 · Medline Industries, Inc. · Apr 2020
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
K192988 · Medline Industries, Inc. · Apr 2020
Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
K191860 · Semperit Technische Produkte Gesellchaft M.B.H. · Mar 2020