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K Number
K121335
Device Name
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
Manufacturer
HUTCHINSON SANTE S.N.C.
Date Cleared
2012-09-13

(133 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
HO
Reference & Predicate Devices
K020918,K994081,K955419
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.

AI/ML Overview

The provided text describes a 510(k) submission for the Hutchinson Santé G-Derm™ Surgical Glove, a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data and adherence to recognized standards, rather than an AI-driven diagnostic or prescriptive device requiring complex clinical studies. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this type of device submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

CharacteristicAcceptance Criteria (Standard)Reported Device Performance
ThicknessMeets ASTM D35770.21 ± 0.02 mm
LengthMeets ASTM D3577280 mm min.
Physical PropertiesMeets ASTM D3577, Type 2Meets ASTM D3577, Type 2
Powder FreeMeets ASTM D6124 (

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).