Cleared Traditional

K150146 - Biogel PI Micro Indicator Underglove

K150146 is an FDA 510(k) clearance for Biogel PI Micro Indicator Underglove, manufactured by Molnlycke Health Care Us, LLC. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K150146 · Molnlycke Health Care Us, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K150146

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

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 549
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K150146.
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K151607 · Lucenxia Prescience AG · Nov 2015
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
K142941 · Pt. Medisafe Technologies · Nov 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
K151392 · Terang Nusa Sdn Bhd · Sep 2015
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs
K150973 · Terang Nusa Snd Bhd · Aug 2015
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs
K142190 · Pt. Medisafe Technologies · Jul 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · Molnlycke Health Care Us, LLC · Mar 2015
K150146 · Biogel PI Micro Indicator Underglove
Download PDF FDA Summary Molnlycke Health Care…