Cleared Traditional

K101163 - BIOGEL ORTHOPRO INDICATOR UNDERGLOVE

K101163 is an FDA 510(k) clearance for BIOGEL ORTHOPRO INDICATOR UNDERGLOVE, manufactured by Molnlycke Health Care USA. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K101163 · Molnlycke Health Care USA · General Hospital
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Nov 2010
Decision
211d
Days
Class 1
Risk

K101163 is an FDA 510(k) clearance for the BIOGEL ORTHOPRO INDICATOR UNDERGLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Molnlycke Health Care USA (Norcross, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 211 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 USA devices

FDA 510(k) Submission Details - K101163

510(k) Number K101163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2010
Decision Date November 23, 2010
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K101163.
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
K110272 · Cardinal Health, Inc. · Jun 2011
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
K111015 · Cardinal Health, Inc. · May 2011
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K102500 · Cardinal Health, Inc. · Nov 2010
PROTEGRITY SMT LATEX SURGICALGLOVES
K101811 · Cardinal Health, Inc. · Oct 2010
SUR-G GLOV AND MAXITEX
K102119 · Terang Nusa Sdn Bhd · Aug 2010