Cleared Traditional

K191869 - Biogel PI UltraTouch S Surgical Glove w...

K191869 is the FDA 510(k) clearance for Biogel PI UltraTouch S Surgical Glove w... 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 245-day FDA review.

K191869 · Molnlycke Health Care Us, LLC · General Hospital
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Mar 2020
Decision
245d
Days
Class 1
Risk

K191869 is an FDA 510(k) clearance for the Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Clai.... 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 March 13, 2020 after a review of 245 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 K191869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2019
Decision Date March 13, 2020
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K191869.
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
JR.MEDIK Latex Surgeon’s Gloves Powder Free
K192328 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Mar 2020
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
K191915 · Medline Industries, Inc. · Mar 2020
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
K192820 · Medline Industries, Inc. · Feb 2020