Cleared Traditional

K150146 - Biogel PI Micro Indicator Underglove

K150146 is the FDA 510(k) clearance for Biogel PI Micro 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 221-day FDA review.

K150146 · Molnlycke Health Care Us, LLC · General Hospital
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Aug 2015
Decision
221d
Days
Class 1
Risk

K150146 is an FDA 510(k) clearance for the Biogel PI Micro Indicator Underglove. 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 August 31, 2015 after a review of 221 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 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 K150146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2015
Decision Date August 31, 2015
Days to Decision 221 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
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 K150146.
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
K161008 · Hartalega Sdn Bhd · Jul 2016
SensiCare PI Surgical Gloves
K152428 · Medline Industries, Inc. · Mar 2016
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
K150238 · Medline Industries, Inc. · Nov 2015
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K113233 · Shen Wei (Usa), Inc. · Mar 2012
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