Cleared Abbreviated

K102177 - SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE

K102177 is an FDA 510(k) clearance for SENSICARE POWDER-FREE POLYMER COATED PO..., manufactured by Medline Industries, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 332-day FDA review.

K102177 · Medline Industries, Inc. · General Hospital
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Jun 2011
Decision
332d
Days
Class 1
Risk

K102177 is an FDA 510(k) clearance for the SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 30, 2011 after a review of 332 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K102177

510(k) Number K102177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date June 30, 2011
Days to Decision 332 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 129d · This submission: 332d
Pathway characteristics
Standards-based clearance path.

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 323
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K102177.
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · Molnlycke Health Care Us, LLC · Aug 2011
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
K103714 · Ansell Healthcare Products, LLC · Jul 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