MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE

K011593 · Ansell Healthcare Products, Inc. · LZA · Jun 21, 2001 · General Hospital

Device Facts

• Record ID: K011593
• Device Name: MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE
• Applicant: Ansell Healthcare Products, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jun 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Device Story

Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile, disposable nitrile gloves. Worn by healthcare examiners on their hands during patient examinations to serve as a protective barrier, preventing cross-contamination between the patient and the examiner. The device is used in clinical settings. It functions as a physical barrier and does not involve electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing, dimension verification, and freedom from holes testing per ASTM D 6319-00 and ASTM D 5151-99. Biocompatibility testing (primary skin irritation and guinea pig sensitization) passed.

Technological Characteristics

Material: Nitrile (synthetic). Form factor: Disposable, non-sterile, powder-free examination glove. Standards: Meets ASTM D 6319-00 (dimensions, physical properties, powder residue) and ASTM D 5151-99 (freedom from holes). Powder residue limit: ≤ 2 mg per glove.

Indications for Use

Indicated for use as a patient examination glove worn by medical examiners to prevent cross-contamination between patient and examiner.

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 011593

Image /page/0/Picture/1 description: The image shows the logo for Ansell Professional Healthcare. The word "Ansell" is in large, bold, sans-serif font, with a thick line underneath it. Below the line, the words "PROFESSIONAL HEALTHCARE" are printed in a smaller, sans-serif font.

## JUN 2 1 2001

1875 Harsh Ave. S.E. . P.O. Box 550 Massillon, OH 44648-0550 U.S.A. 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com

Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax:

- [1] Summary
- Ansell Healthcare Products Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646

James R. Chatterton Contact: Telephone: [phone] Fax:

May 23, 2001

- Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves [3] Trade Name: Common Name: Examination Gloves Classification Name: Glove, Patient Examination, Poly
- [4] Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves meet all of the requirements of ASTM D 6319-00.
- Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves meet all the current [5] specifications for ASTM D 6319-00 Rubber Examination Gloves.
- Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable [6] devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|---------------------|-------------------------------------------------------------------------|
| Dimensions | Meets ASTM D 6319-00 |
| Physical Properties | Meets ASTM D 6319-00 |
| Freedom from holes | Meets ASTM D 6319-00<br>Meets ASTM D 5151-99 |
| Powder-Free | Meets ASTM D 6319-00<br>Not more than 2 mg residue by mass pe<br>glove. |

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Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: [phone] Fax:

Biocompatability Primary Skin İrritation in Rabbits Guinea Pig Sensitization

Passes Passes

- The performance test data of the non clinical tests are the same as mentioned immediately above. (8)
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. (9)
- It is concluded that the Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves [10] (Modified) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 1 2001

Mr. James R. Chatterton Vice President of Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, SE Massillon, Ohio 44646

Re: K011593 Micro-Touch Nitrile Powder Free Trade/Device Name: Synthetic Medical Examination Gloves, Color Blue Non-Sterile 880.6250 Requlation Number: Regulatory Class: I Product Code: LZA Dated: May 23, 2001 May 24, 2001 Received:

#### Dear Mr. Chatterton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Mr. Chatterton

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic chrough Siz or on ontrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in possible equivalence of your device to a legally marketed predicate device results in a classification for your markeess produced permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che promote of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours

Kielchrist

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

## Indications for Use Statement

| 510(k)<br>Number<br>(if known) | K011593 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves (BLUE) |
| Indications for Use | Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for<br>medical purposes that is worn on the examiners hand to prevent contamination<br>between patient and examiner. |

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# Concurrence of CDRH Office of Device Evaluation (ODE)

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