DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U

K111139 · Ansell Healthcare Products, Inc. · KGO · Sep 2, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111139
• Device Name: DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
• Applicant: Ansell Healthcare Products, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended 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.

Device Story

Disposable sterile surgical glove; synthetic polyisoprene rubber construction; inner surface coated with aliphatic polyester polyurethane for donning. Used by operating room personnel to protect surgical wounds from contamination; provides barrier protection against chemotherapy drugs. Tested per ASTM D6978-05 for permeation breakthrough times against specific chemotherapy agents. Protects healthcare professionals from toxic chemical exposure during handling. No electronic components or software.

Clinical Evidence

No clinical data; bench testing only. Device performance validated against ASTM D3577-09e1 (dimensions, physical properties, freedom from holes), ASTM D6124-06 (powder content), ASTM D5712 (protein content), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via dermal sensitization and primary skin irritation studies per ISO 10993.

Technological Characteristics

Material: Synthetic polyisoprene rubber with aliphatic polyester polyurethane inner coating. Dimensions/Physical Properties: ASTM D3577-09e1. Freedom from Holes: ASTM D5151-06. Powder-Free: ASTM D6124-06 (≤ 2 mg/glove). Protein Content: ASTM D5712 (max 50 µg/dm²). Biocompatibility: ISO 10993 compliant. Sterile.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination and provide barrier protection during handling of chemotherapy drugs.

Regulatory Classification

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.

Predicate Devices

• Cardinal Health Duraprene SMT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K013302)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### 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: [phone] Telephone: [phone]

- 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 | Substantial<br>Equivalence (SE)? |
| | Derma Prene® Isotouch® Green<br>Sterile Powder-Free<br>Polyisoprene Surgical Gloves,<br>Tested for Use with<br>Chemotherapy Drugs | Cardinal Health Duraprene SMT<br>Gloves, Tested for Use with<br>Chemotherapy Drugs<br>(Allegiance Healthcare<br>Corporation K013302) | |
| Indications for<br>Use | These gloves are intended to be<br>worn by operating room<br>personnel to protect a surgical<br>wound from contamination, and<br>are tested for use with<br>chemotherapy drugs. | These gloves are intended for<br>use in environments within<br>hospitals and other healthcare<br>facilities. The gloves are<br>appropriate for use during<br>invasive as well as non-invasive<br>medical procedures requiring<br>sterility. They are intended to<br>be worn by operating room<br>personnel to protect a surgical<br>wound form contamination. | Yes, Substantially<br>Equivalent |
| Chemotherapy<br>Permeation<br>Standard | Meets ASTM D6978-05 | Meets ASTM F739-91 | Yes, Substantially<br>Equivalent |
| Design<br>Specifications | Meets ASTM D3577-09e1 | Meets ASTM D3577 and<br>EN 455-2 | Yes, Substantially<br>Equivalent |
| Performance | Meets ASTM D3577-09e1 | Meets ASTM D3577 and<br>EN 455-2 | Yes, Substantially<br>Equivalent |
| Materials | Flexible Synthetic Rubber -<br>Synthetic Polyisoprene Rubber<br>and Aliphatic Polyester<br>Polyurethane inner coating to<br>aid donning | Flexible Synthetic Rubber -<br>Neoprene and Nitrile for easy<br>donning | Yes, Substantially<br>Equivalent |
| Biocompatibility | Passes | Passes | Yes, Substantially<br>Equivalent |
| Sterility | Sterile | Sterile | Identical |
| Color | Synthetic Glove with embedded<br>Colorant -Green | Synthetic Glove with embedded<br>Colorant -Flesh | Yes, Substantially<br>Equivalent |
| Powder-Free | Meets Applicable Definition for<br>Powder Free: < 2 mg per glove | Meets Applicable Definition for<br>Powder 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.
- 2. 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 [phone] or [phone] 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