The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.

Device Description

Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.

AI/ML Overview

The provided text does not describe an AI/ML powered medical device. Instead, it is an FDA 510(k) premarket notification for a medical device called "Gammex® Cut Resistant Glove Liner."

Therefore, it is not possible to answer the request based on the provided document as the questions are specific to the acceptance criteria and study design for an AI/ML powered device.

The document focuses on demonstrating that a cut-resistant glove liner is "substantially equivalent" to a legally marketed predicate device, primarily through performance data against standards (e.g., ANSI/ISEA 105 for cut level, ISO 10993 for biocompatibility) rather than clinical studies or AI model performance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2016

Ansell Healthcare Products LLC Mr. Robert Mahler Director, Regulatory Affairs for the Americas 111 Wood Avenue South. Suite 210 Iselin, New Jersey 08830

Re: K160974

Trade/Device Name: Gammex (R) Cut Resistant Glove Liner Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: September 28, 2016 Received: September 30, 2016

Dear Mr. Mahler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160974

Device Name Gammex (R) Cut Resistant Glove Liner

Indications for Use (Describe)

The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an imer and outer surgical glove liner should be worn between two surgical gloves.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1. 510(k) Summary

Submitter

Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830

Contact Person:

Robert Mahler Director Regulatory Affairs for the Americas Phone: (732) 345-2174 Email: rob.mahler(@ansell.com

Date prepared:

October 25, 2016

Name of Device:

Trade name:	Gammex® Cut Resistant Glove Liner
Common name:	Glove Liners/Undergloves
Classification name:	Surgeon's Glove (accessory)
Classification regulation:	21 CFR 878.4460
Device class:	I
Product code:	KGO
Classification panel:	General and plastic surgery

Legally marketed predicate device:

K922407 - Wells Lamont Cut Resistant Surgical Glove Liners

Device description:

Indications for use statement:

The Gammex(R) Cut Resistant Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.

Technological characteristics:

Gammex® Cut Resistant Glove Liner has the following technological characteristics as compared to ASTM or equivalent standards

{4}------------------------------------------------

Technological Characteristic	Standard	Result Summary
Cut level 2	ANSI/ISEA 105 Clause 5.1.1	Weight (g) needed to cutthrough material $\geq$ 500

ISO In Vitro Cytotoxicity	ISO 10993-5:2009	Under the conditions of thestudy, not cytotoxic

ISO Skin Irritation Study	ISO 10993-10:2010	Under the conditions of thestudy, not an irritant

ISO MaximizationSensitization Study	ISO 10993-10:2010	Under the conditions of thestudy, not a sensitizer

Substantial Equivalence

Substantial Equivalence Comparison Table
------------------------------------------

	Predicate Device	Subject Device	SubstantiallyEquivalent
Trade Name	Wells Lamont Cut ResistantSurgical Glove Liners	Gammex® Cut ResistantGlove Liner	As noted
510(k)Number	K922407	To be declared	As noted
Indicationsfor use	A cut resistant glove liner forimproved protection fromcuts, slashes, and sharpinstrument. For optimumbarrier protection, it issuggested that a latex surgicalglove be worn over and underthe glove liner. The liner maybe reused	Cut Resistant Liner is asingle use glove linerintended to provideANSI/ISEA 105 Cut LevelProtection 2 against cutswhen used with an inner andouter surgical glove. Theglove liner should be wornbetween two surgical gloves.	As noted
Material	Ultra-high molecular weightpolyethylene fibre	Ultra-high molecular weightpolyethylene fibre	Equivalent
Color	White	White	Equivalent
Design	Knitted glove, ambidextrous,straight fingers	Knitted glove, ambidextrous,straight fingers	Equivalent
Cuff feature	Coloured coded and a labelattached on cuff to notenumber of reusable.	Coloured coded and a labelattached on cuff to notenumber of reusable.	Equivalent
Cut level	ANSI Cut Level 2 accordingto ASTM F1790-97	ANSI Cut Level 2 accordingto ASTM F1790-97	Equivalent
Reusable	Laundry up to the readableguide on the cuff edge label.Washing, drying anddisinfection with sodiumhypochlorite or alkalineglutaraldehyde. Re-sterilisation via auto clave orethylene oxide gas	Single use only	As noted

{5}------------------------------------------------

	Predicate Device	Subject Device	SubstantiallyEquivalent
Sterilization	Ethylene Oxide gasMeeting sterility assurancelevel, SAL 10 -6	Gamma IrradiationMeeting sterility assurancelevel, SAL 10-6	As noted
Glove Length	XS – 6 3/8”S - 7 1/2”M - 8”L - 8 3/8”XL – 8 3/4”	XS – 6 3/8”S - 6 7/8”M - 7 1/8”L - 7 1/8”XL - 7 1/2 ”	As noted.

The cut resistant under glove liner is a white color glove liner knitted from an ultrahigh molecular weight polyethylene (UHMWPE) fibers that offers cut resistance. The glove liner is knitted using UHMWPE varn as the main strengthening component along with Nylon and Spandex for comfort.

The cut resistance under glove is designed to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts for the hands of surgeons, nurse or any personal involving in surgeries by giving cut protection level 2 during the surgeries. The glove to be worn between two surgical glove inner and outer as a under glove.

The glove is manufactured from similar type materials to provide equivalent material, color, design, cuff feature and cut level performance as the predicate. The sterilization process though differs but achieves the required sterility. Biocompatibility was done on the subject device to show that the product was not cytotoxic, an irritant or a sensitizer consistent with the ISO 10993 series of standards.

Performance Data

A clinical study was not conducted on the subject device or the predicate device.

Substantial Equivalence Statement

The Gammex® Cut Resistant Glove Liner is substantially equivalent to the predicate device with respect to the design, technological characteristics, and conformance to standards requirements. The device differs from the predicate in that it is a single use device.

Regulation Number and Section

§ 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).