MICRO-TOUCH NITRA FREE

K092327 · Ansell Healthcare Products, LLC · LZA · Sep 21, 2009 · General Hospital

Device Facts

• Record ID: K092327
• Device Name: MICRO-TOUCH NITRA FREE
• Applicant: Ansell Healthcare Products, LLC
• Product Code: LZA · General Hospital
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Device Story

Non-sterile, powder-free nitrile examination gloves; designed for use by healthcare personnel to prevent cross-contamination; tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Gloves act as a physical barrier; worn on hands during patient care or drug handling. Provides protection against fluids and waste; breakthrough times for various chemotherapy agents documented. No complex processing or electronic components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on non-clinical bench testing including physical property, biocompatibility, and chemotherapy drug permeation testing.

Technological Characteristics

Nitrile examination gloves; powder-free (≤2 mg/glove); meets ASTM D6319-00a(2005) specifications. Biocompatibility: ISO skin irritation, sensitization, and cytotoxicity (non-toxic at 24 hours). Chemotherapy permeation tested per ASTM D6978-05. Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier against contamination between the user and the patient's body, fluids, waste, or environment, and for handling chemotherapy drugs.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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K692327

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 Contact Information:

> Cynthia A. Ingram, Regulatory Affairs Manager, Americas Telephone: [phone] Fax: [phone]

SEP 2 1 2009

## 3.0 Name of Device:

Trade Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use)

Patient Examination Gloves Common Name:

Classification Name: Glove, Patient Examination, Nitrile

- 4.0 Identification of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).

### 5.0 Description of the Device:

Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.

6.0 Intended Use of the Device:

> Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

7.0 Summary of Technological Characteristics of the Device:

> Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

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| Characteristics | Standard | Device Performance |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D 6319-00a(2005) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) | Meets |
| Freedom from<br>Holes | ASTM D 6319-00a(2005) | Meets |
| Holes | ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤2 mg per glove |
| Biocompatibility | ISO Skin Irritation Study | Passes |
| | ISO Maximization<br>Sensitization Study - Extract<br>Cytotoxicity Study Using the<br>End-Point Titration Method | Passes<br>Non-toxic at 24 hours for<br>dilutions 1:2 through 1:32 |
| Chemotherapy<br>Drug<br>Permeation Test | ASTM D 6978-05 | Chemotherapy Drug Permeation<br>(average breakthrough time in<br>minutes)<br>Carmustine 45.27<br>Cyclophosphamide >240<br>Doxorubicin Hydrochloride >240<br>Etoposide (Toposar) >240<br>5-Fluorouracil >240<br>Paclitaxel (Toxol) >240<br>Thio-Tepa 93.50<br>Vincristine Sulfate >240<br>Methotrexate >240 |

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

The performance test data of the non-clinical tests are the same as mentioned immediately above.

9.0 Substantial Equivalence Based on Assessment of Clinical Performance Data:

Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.

## 10.0 Conclusion:

It is concluded that Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:

> ASTM listed standards, FDA hole requirements, and labeling claims for the product.

This device is substantially equivalent to currently marketed devices.

This summary will include any other information reasonably deemed necessary by the FDA.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ansell Healthcare Products LLC C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories. Incorporated 1285 Walt Whitman Road Melville, New York 11747

Re: K092327

Trade/Device Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I . Product Code: LZA, LZC Dated: September 4, 2009

Received: September 8, 2009

Dear Mr. Conry:

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.

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. Conry

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/CDRH/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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Archer

Susan Runner, D.D.S., M.A. Acting 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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## 3.0 Indications for Use Statement:

# INDICATIONS FOR USE

510(K) Number (if known): K092327

Device Name:

Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs

## Indications For Use:

This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.

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

AND/OR

| *Carmustine | 45.27 |
|---------------------------|-------|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| Thio-Tepa | 93.50 |
| Vincristine Sulfate | >240 |
| Methotrexate | >240 |

*Caution: Testing showed an average breakthrough time of 45 minutes with Carmustine.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Shula A. Murphy, MD

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

**510(k) Number:** K192327