Cleared Traditional

K140477 - BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES (FDA 510(k) Clearance)

Class I General Hospital device.

K140477 · Molnlycke Health Care Us, LLC · General Hospital
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Mar 2015
Decision
390d
Days
Class 1
Risk

K140477 is an FDA 510(k) clearance for the BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES. 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 23, 2015 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K140477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2014
Decision Date March 23, 2015
Days to Decision 390 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
262d slower than avg
Panel avg: 128d · This submission: 390d
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 557
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K140477.
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Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
K232079 · Wrp Asia Pacific Sdn. Bhd. · Mar 2024
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K231973 · Ineo Tech Sdn Bhd · Sep 2023