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

K042817 · Ansell Healthcare Products, Inc. · LZA · Dec 6, 2004 · General Hospital

Device Facts

• Record ID: K042817
• Device Name: MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
• Applicant: Ansell Healthcare Products, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Dec 6, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves are non-sterile, disposable nitrile gloves. Used by healthcare personnel to provide a protective barrier against patient body fluids, waste, and environmental contaminants; specifically indicated for handling chemotherapy drugs. Device functions as a physical barrier; worn on hands. No electronic or mechanical components. Benefits include reduction of cross-contamination risk during clinical procedures and chemotherapy drug administration.

Clinical Evidence

No clinical data. Bench testing only. Device meets ASTM D6319-00ae3 specifications for physical properties, dimensions, and freedom from holes (ASTM D5151-99). Biocompatibility testing (primary skin irritation and guinea pig sensitization) passed.

Technological Characteristics

Material: Nitrile. Powder-free (≤ 2 mg per glove). Dimensions and physical properties meet ASTM D6319-00ae3. Freedom from holes meets ASTM D6319-00ae3 and ASTM D5151-99. Non-sterile, disposable form factor.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective 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)

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K 042817

# DEC - 6 2004

- 510(k) SUMMARY [1]
- [2] Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303

| Contact: | Lon D. McIlvain, Vice President Regulatory Affairs |
|------------|----------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |

October 8, 2004

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

Classification Name: Glove, Patient Examination, Nitrile

- (4) Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00ae3.
- Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) [ર] meet all of the current specifications of ASTM D6319-00ae3, Standard Specification for Nitrile Examination Gloves for Medical Application.
- Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) (୧) 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] Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|------------------------------------------------------------------------------------|-------------------------------------------------|
| Dimensions | Meets ASTM D 6319-00ae3 |
| Physical Properties | Meets ASTM D 6319-00ae3 |
| Freedom from Holes | Meets ASTM D 6319-00ae3<br>Meets ASTM D 5151-99 |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility<br>Primary Skin Irritation in Rabbits<br>Guinea Pig Sensitization | Passes<br>Passes |

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- [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 510(k) [9] process.
- It is concluded that Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves [10] (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.

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Mr. Lon D. McIlvain Vice President Regulatory Affairs Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, Alabama 36303

Re: K042817

Trade/Device Name: Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 8, 2004 Received: October 12, 2004

Dear Mr. Mcllvain:

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.

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## Page 2 - Mr. McIlvain

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); 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Surer Rumser
C. Chia-Lin, Ph.D.

Chiu Lin, Ph.D. 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

Applicant:

Ansell Healthcare Products LLC

510(K) Number (if known): _ K 04 28 17 _______________________________________________________________________________________________________________________________________

Device Name:

Micro-Touch Smooth 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.

Concurrence of CDRH Office of Device Evaluation (ODE)

Suaga Ramo

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

510(k) Number: k042877

Prescription Use Per 21 CFR 801.109 Or

Over-the-Counter Use