These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.

Device Description

The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Standard/Acceptance Criteria	Reported Device Performance
Dimensions	ASTM D3577-09e1	Meets
Physical Properties	ASTM D3577-09e1	Meets
Freedom from Holes	ASTM D3577-09e1, ASTM D 5151-06	Meets
Powder-Free	ASTM D 6124-06 (≤ 2 mg per glove)	≤ 2 mg per glove
Protein Content	ASTM D3577-09e1, ASTM D 5712 (Maximum 50 µg/dm²)	Maximum 50 µg/dm²
Biocompatibility	Dermal Sensitization (Passes)	Passes
	Primary Skin Irritation Study (Passes)	Passes
Chemotherapy Drug Permeation	ASTM D6978-05 (Average breakthrough detection time in minutes)	Carmustine: 15.5 min
		Cyclophosphamide: >240 min
		Doxorubicin Hydrochloride: >240 min
		Etoposide (Toposar): >240 min
		5-Fluorouracil: >240 min
		Paclitaxel (Taxol): >240 min
		ThioTEPA: 15.5 min
		Methotrexate: >240 min
		Vincristine Sulfate: >240 min

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for testing each characteristic. However, the testing was done against established ASTM (American Society for Testing and Materials) standards. These standards typically specify appropriate sample sizes and testing methodologies. The data provenance is not explicitly mentioned regarding country of origin or whether it was retrospective or prospective, but it implies prospective testing conducted to meet the specified ASTM standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. The "ground truth" for the device's performance is established by meeting the specified ASTM standards, which are objective, standardized tests for physical and chemical properties. These standards do not typically rely on "expert consensus" in the same way clinical diagnostic devices might.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The testing performed is objective and based on established ASTM methods, not on interpretation or consensus among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted. The device is a surgical glove, and its effectiveness is measured by its physical properties and barrier protection, not by human reader interpretation of images or data.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted. This concept is relevant for AI/software-as-a-medical-device. The device in question is a physical product (surgical gloves).

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for this device is based on objective measurements and results from standardized laboratory tests according to ASTM and ISO standards. This includes:

Physical measurements (e.g., dimensions, force at break).
Chemical analysis (e.g., powder residue, protein content).
Barrier integrity testing (e.g., freedom from holes, chemotherapy drug permeation).
Biocompatibility assessments (dermal sensitization, primary skin irritation).

8. Sample Size for the Training Set:

This information is not applicable/provided. The device is a physical product, not an AI algorithm that requires a "training set." Manufacturing processes are designed to produce gloves meeting specifications, and quality control systems ensure adherence to these specifications.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the word "Ansell" in a bold, sans-serif font. The word is underlined with a thick, slightly curved line. The text and the line are both black, contrasting with the white background.

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1635 Industrial Road Dothan, AL 36303 Tel: (334) 615-2563 Fax: (334) 615-2574

510(k) SUMMARY

1.0 Submitter: Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303

2.0 Date of Preparation: July 21, 2011

3.0 Contact Information: Cynthia A. Ingram, Regulatory Affairs Manager, Americas Fax: 334-615-2573 Telephone: 334-615-2563

4.0 Name of Device: Trade Name: Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs
Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves
Legally Marketed Device to Which Equivalence is being Claimed: રું. વ
Device Name: Cardinal Health Duraprene SMT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

510(k) Number: K013302

6.0 Identification of the Device:
Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs
7.0 Description of the Device:
The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.

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8.0 Intended Use of the Device:

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.

Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)

*Carmustine	15.5
Cyclophosphamide	>240
Doxorubicin Hydrochloride	>240
Etoposide (Toposar)	>240
5-Fluorouracil	>240
Paclitaxel (Toxol)	>240
*ThioTEPA	15.5
Methotrexate	>240
Vincristine Sulfate	>240

Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.

ਰੇ.0 Summary of Technological Characteristics of the Device:

Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs have the following technological characteristics compared to ASTM or equivalent standards:

Characteristics	Standard	Device Performance
Dimensions	ASTM D3577-09e1	Meets
Physical Properties	ASTM D3577-09e1	Meets
Freedom from Holes	ASTM D3577-09e1	Meets
	ASTM D 5151-06
Powder-Free	ASTM D 6124-06	≤ 2 mg per glove
Protein Content	ASTM D3577-09e1	Maximum 50 µg/dm²
	ASTM D 5712
Biocompatibility	Dermal Sensitization	Passes
	Primary Skin Irritation Study	Passes

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Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 10.0

Comparison to Predicate – The subject device (Derma Prené® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs) compares favorably to the predicate device (Cardinal Health Duraprene SMT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs) as indicated in the tabulated summary below.

Substantial Equivalence Comparison Table
	Subject Device	Predicate Device	SubstantialEquivalence (SE)?
	Derma Prene® Isotouch® GreenSterile Powder-FreePolyisoprene Surgical Gloves,Tested for Use withChemotherapy Drugs	Cardinal Health Duraprene SMTGloves, Tested for Use withChemotherapy Drugs(Allegiance HealthcareCorporation K013302)
Indications forUse	These gloves are intended to beworn by operating roompersonnel to protect a surgicalwound from contamination, andare tested for use withchemotherapy drugs.	These gloves are intended foruse in environments withinhospitals and other healthcarefacilities. The gloves areappropriate for use duringinvasive as well as non-invasivemedical procedures requiringsterility. They are intended tobe worn by operating roompersonnel to protect a surgicalwound form contamination.	Yes, SubstantiallyEquivalent
ChemotherapyPermeationStandard	Meets ASTM D6978-05	Meets ASTM F739-91	Yes, SubstantiallyEquivalent
DesignSpecifications	Meets ASTM D3577-09e1	Meets ASTM D3577 andEN 455-2	Yes, SubstantiallyEquivalent
Performance	Meets ASTM D3577-09e1	Meets ASTM D3577 andEN 455-2	Yes, SubstantiallyEquivalent
Materials	Flexible Synthetic Rubber -Synthetic Polyisoprene Rubberand Aliphatic PolyesterPolyurethane inner coating toaid donning	Flexible Synthetic Rubber -Neoprene and Nitrile for easydonning	Yes, SubstantiallyEquivalent
Biocompatibility	Passes	Passes	Yes, SubstantiallyEquivalent
Sterility	Sterile	Sterile	Identical
Color	Synthetic Glove with embeddedColorant -Green	Synthetic Glove with embeddedColorant -Flesh	Yes, SubstantiallyEquivalent
Powder-Free	Meets Applicable Definition forPowder Free: < 2 mg per glove	Meets Applicable Definition forPowder Free: < 2 mg per glove	Identical

Substantial Equivalence Comparison Table

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Summary of Differences and Comparison of Safety and Effectiveness – The subject device differs from the predicate in that:

1. The subject device in manufactured from neoprene with the inner surface coated with aliphatic polyester polyurethane donning aid. The predicate device is manufactured from a combination of neoprene and nitrile. Though the materials of construction differ, the subject device's materials are functionally equivalent to those of the cited predicate.
1. Chemotherapeutic agent penetration time testing relevant to the safety of healthcare professionals, with regard to effectiveness of protection from potentially toxic chemicals, was more rigorous for the subject device, and the subject device is therefore substantially equivalent to the predicate.

Non-clinical Comparison to Applicable Standards – The subject device meets the applicable requirements for surgeons gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577, ASTM D5151, ASTM D6124, and ASTM D5712. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.

Substantial Equivalence Based on an Assessment of Clinical Performance Data: 11.0 A clinical study was not conducted on the subject or predicate devices.
12.0 Conclusion:

The Encore Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs are as safe and effective as the predicate device. The subject device has been tested against the ASTM standards listed above and met the requirements of those standards. Additional comparisons show the subject device substantially equivalent to the predicate.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human figures connected by flowing lines.

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

Ansell Healthcare Products, Incorporated % Mr. Neil Burris Regulatory Affairs Consultant Reglera LLC 555 Zang Street, Suite 100 Lakewood Colorado 80228

2 2011

Re: K111139

Trade/Device Name: Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: August 2, 2011 Received: August 4, 2011

Dear Mr. Burris:

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.

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Page 2 - Mr. Burris

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CIDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincercly yours,

Anthony V. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K111139

3.0 Indications for Use Statement:

INDICATIONS FOR USE

510(k) Number (if known): K11139

Device Name:

Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs

Indications For Use:

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.

Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)

*Carmustine	15.5
Cyclophosphamide	>240
Doxorubicin Hydrochloride	>240
Etoposide (Toposar)	>240
5-Fluorouracil	>240
Paclitaxel (Taxol)	>240
*ThioTEPA	15.5
Methotrexate	>240
Vincristine Sulfate	>240

Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE FF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Elishath F. Clavie-Wells

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K !!!! 3 9

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).