MICRO-TOUCH NITRILE

K093523 · Ansell Healthcare Products, LLC · LZA · Mar 4, 2010 · General Hospital

Device Facts

• Record ID: K093523
• Device Name: MICRO-TOUCH NITRILE
• Applicant: Ansell Healthcare Products, LLC
• Product Code: LZA · General Hospital
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Nitrile powder-free examination glove; provides barrier protection for healthcare personnel against patient fluids, waste, and environment. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; worn by healthcare workers. Output is physical barrier protection; aids in infection control and safety during chemotherapy handling. Benefits include reduced risk of cross-contamination and chemical exposure.

Clinical Evidence

Bench testing only. No clinical data required for this device type. Performance verified via ASTM standards for dimensions, physical properties, freedom from holes (ASTM D5151-06), powder content (ASTM D6124-06), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility confirmed via primary skin irritation and dermal sensitization animal assays.

Technological Characteristics

Nitrile examination glove; powder-free (≤2 mg/glove). Complies with ASTM D6319-00a(2005)e1. Barrier integrity tested per ASTM D5151-06. Chemotherapy resistance 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 wearer and the patient's body, fluids, waste, or environment. Tested for use with specific chemotherapy drugs. Contraindicated for use with Carmustine and ThioTEPA.

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.

Predicate Devices

• Non-Sterile Powder-Free Blue Color Nitrile Examination Gloves (K031580)

Submission Summary (Full Text)

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K093523

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, black line. The font is a simple, blocky style, and the overall design is clean and straightforward. The image is likely a logo or branding element for the company Ansell.

MAR ~ 4 2010

1635 Industrial Road Dothan, AL 36303 Tel: [phone] Fax: [phone]

### 510(k) SUMMARY

- February 4, 2010 1) Date:
- 2) Submitter:

February 4, 2010

- Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
- Cynthia A. Ingram, Regulatory Affairs Manager, Americas 3) Contact Information: [phone] Fax: [phone] Telephone:
- 4) Name of Device:

| Trade Name: | Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Patient Examination Gloves |
| Classification Name: | Glove, Patient Examination, Nitrile |

5) Legally Marketed Device to Which Equivalency is being Claimed:

Device Name: Non-Sterile Powder-Free Blue Color Nitrile Examination Gloves 510(k) Number: K031580

- 6) Identification of the Device:
Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D 6319-00a(2005)e1.

- 7) Description of the Device:
Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the current specifications of ASTM D6319-00a(2005)e1, Standard Specification for Nitrile Examination Gloves for Medical Application.

- 8) Intended Use of the Device:
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)

| *Carmustine | 12.4 |
|---------------------------|------|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| *ThioTEPA | 19.6 |
| Cisplatin | >240 |
| Dacarbazine | >240 |

*WARNING: Do not use with Carmustine or ThioTEPA.

1

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K093523

- 9) Summary of Technological Characteristics of the Device:
Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard | Device Performance |
|-----------------------|-------------------------------------------------------------------------------------------|--------------------|
| Dimensions | ASTM D 6319-00a(2005)e1 | Meets |
| Physical Properties | ASTM D 6319-00a(2005)e1 | Meets |
| Freedom from<br>Holes | ASTM D 6319-00a(2005)e1<br>ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤2 mg per glove |
| Biocompatibility | Primary Skin Irritation<br>(Animal Study)<br>Dermal Sensitization Assay<br>(Animal Study) | Passes<br>Passes |

10) 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.

11) 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.

12) Conclusion:

It is concluded that Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs are as safe, as effective, and perform as well as the glove performance standards referenced in Section 8 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing segments, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### Public Health Service

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

Ms. Cynthia A. Ingram Regulatory Affairs Manager Ansell Healthcare Products LLC 1635 Industrial Road Dothan, Alabama 36303

# MAR - 4 2010

Re: K093523

Trade/Device Name: Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 4, 2010 Received: February 12, 2010

Dear Ms. Ingram:

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 vour 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- Ms. Ingram

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Kimes

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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K093523

#### 3.0 Indications for Use Statement:

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Micro-Touch® Nitrile Powder-Free Blue 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)

| *Carmustine | 12.4 |
|---------------------------|------|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| *ThioTEPA | 19.6 |
| Cisplatin | >240 |
| Dacarbazine | >240 |

### * WARNING: Do not use with Carmustine or ThioTEPA.

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

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)

Elizabet F. Hamin-Wells

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

510(k) Number: k093523

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