MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)

K082457 · Ansell Healthcare Products, Inc. · LZA · Nov 10, 2008 · General Hospital

Device Facts

• Record ID: K082457
• Device Name: MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
• Applicant: Ansell Healthcare Products, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Nov 10, 2008
• 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 for use in handling chemotherapy drugs.

Device Story

Sterile, disposable nitrile examination gloves; worn by healthcare personnel to provide barrier protection against patient body fluids, waste, and environmental contaminants; specifically indicated for handling chemotherapy drugs. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings; no specialized operation required. Benefits include reduction of cross-contamination risk between patient and provider.

Clinical Evidence

No clinical data. Evidence consists of bench testing including physical property testing, dimension verification, freedom from holes (ASTM D5151-06), and biocompatibility studies (ISO skin irritation and sensitization).

Technological Characteristics

Nitrile examination glove; powder-free (content ≤ 2 mg/glove); sterile. Meets ASTM D6319-00a(2005) for dimensions and physical properties. Biocompatibility confirmed via ISO skin irritation and sensitization studies.

Indications for Use

Indicated for use by health care and similar personnel as a sterile, disposable barrier to prevent cross-contamination between personnel and patients, including handling of 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)

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

# Ansell

X082457

#### 510(k) SUMMARY [1]

- Ansell Healthcare Products LLC (2) 1635 Industrial Road Dothan, AL 36303
NOV 1 0 2008

Lon D. McIlvain, Vice President Regulatory and Quality Affairs Global Contact: [phone] Telephone: [phone] Fax:

February 26, 2008

- Trade Name: Micro-Touch® NitraTexTM Sterile Nitrile Powder-Free Blue [3] Examination Gloves (Chemotherapy Use)
Common Name: Examination Gloves

Classification Name: Glove, Patient Examination, Nitrile

- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves [4] (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves િરો (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (୧) (Chemotherapy Use) are 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.
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves [7] (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Dimensions | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005)<br>Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility:<br>ISO Skin Irritation Study<br>ISO Maximization Sensitization Study - Extract | No irritation<br>No irritation |

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

- [8] The performance test data of the non-clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the [9] 510(k) process.
- [10] It is concluded that Micro-Touch® NitraTexTM Sterile Nitrile Powder-Free Blue 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.

- [1] This summary will include any other information reasonably deemed necessary by the FDA.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 1 0 2008

Re: K082457

Trade/Device Name: Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 20, 2008 Received: October 21, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

### 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 complics 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Suite H. Melvin Oms FOR DR CHIU HN

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

#### 510(K) Number (if known):

Device Name:

Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)

#### 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 for use in handling chemotherapy drugs.

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

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

AND/OR

Concurrence of CDRH Office of Device Evaluation (ODE)

Shudy R. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082457