Cleared Traditional

K190077 - Biogel PI UltraTouch S Surgical Glove

K190077 is the FDA 510(k) clearance for Biogel PI UltraTouch S Surgical Glove 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 128-day FDA review.

K190077 · Molnlycke Health Care Us, LLC · General Hospital
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May 2019
Decision
128d
Days
Class 1
Risk

K190077 is an FDA 510(k) clearance for the Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Un.... 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 May 24, 2019 after a review of 128 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 K190077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2019
Decision Date May 24, 2019
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 K190077.
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K183536 · Hartalega NGC Sdn. Bhd. · Aug 2019
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
K183389 · Hartalega NGC Sdn. Bhd. · Jun 2019
FlexGard Cut-Resistant Glove Liners
K190782 · Ldi Corporation · Jun 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
K190018 · Ansell Healthcare Products, LLC · May 2019
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
K182176 · Pt. Medisafe Technologies · Mar 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · Ansell Healthcare Products, LLC · Mar 2019