NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

K992768 · Ansell Perry · LZA · Oct 13, 1999 · General Hospital

Device Facts

• Record ID: K992768
• Device Name: NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
• Applicant: Ansell Perry
• Product Code: LZA · General Hospital
• Decision Date: Oct 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Device Story

Nitra-Touch sterile powder-free nitrile examination glove; disposable barrier device; worn on examiner's hand; prevents cross-contamination between patient and examiner; used in clinical settings; manufactured from nitrile; meets ASTM D 6319 standards for physical properties and dimensions; provides protection during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ASTM D 6319 (dimensions, tensile strength), ASTM D 5151 (freedom from holes), and ASTM D 6124 (powder residue). Biocompatibility confirmed via rabbit skin irritation and guinea pig sensitization studies.

Technological Characteristics

Material: Nitrile. Form factor: Sterile, powder-free examination glove. Standards: ASTM D 6319 (dimensions, physical properties), ASTM D 5151 (freedom from holes), ASTM D 6124 (powder residue < 2 mg). Biocompatibility: Passes primary skin irritation and guinea pig sensitization tests.

Indications for Use

Indicated for use as a protective barrier worn on the examiner's hand to prevent cross-contamination between patient and examiner in medical settings.

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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Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry

OCT 1 3 1999

1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: Fax: [phone]

K992768

Checklist Section 21.0

- 510 (k) Summary [1]
- [2] Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646

Telephone: [phone] Fax: [phone]

James R. Chatterton Contact: 8/11/99 Date:

- Nitra-Touch™ Sterile [3] Trade Name: Exam Gloves Common Name: Patient Examination Glove Classification Name:
- Nitra-Touch™ Sterile examination gloves, meet all of the requirements of ASTM Standard D 6319 . [4] Nitrile Examination Gloves for Medical Application.
- Nitra-Touch™ Sterile examination gloves exceed the physical requirements of ASTM standard D [૨] 6319 Nitrile Examination Glove for Medical Application.
- Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that [୧] is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Nitra-Touch™ Sterile examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standard |
|--------------------------------------------------|---------------------------------------------------------|
| Dimensions | Meets ASTM D 6319 |
| Physical Properties<br>Tensile Strength, minimum | Meets ASTM D 6319<br>14 Mpa |
| Freedom from holes | Meets ASTM D 6319<br>Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass<br>Meets ASTM D 6124 |

Ansell Healthcare Products Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.ansell.com Telephone: [phone] · Toll Free: 800-321-9752 (USA only) · Fax: [phone]

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Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 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 Nitra-Touch™ Sterile examination gloves are as safe, as effective, and perform [10] as well as or better than 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 summary will include any other information reasonably deemed necessary by The FDA. [11]

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a human figure, with flowing lines suggesting movement or growth.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Ansell Healthcare Products Inc. 1875 Harsh Avenue S.E. Massillon, Ohio 44646

K992768 Re : Trade Name: Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Gloves Regulatory Class: I Product Code: LZA August 11, 1999 Dated: August 17, 1999 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 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 controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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## Page 2 - Mr. Chatterton

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 Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Susan Runno

t

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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~ ^ Indications for Use Statement:

## INDICATIONS FOR USE

| Applicant: | Ansell Perry |
|---------------------------|--------------------------------------------------------------------------------------------|
| 510(K) Number (if known): | K992768 * |
| Device Name: | Nitra-Touch Patient Examination Glove, Sterile, Nitrile, Green Color, Sterile, Powder Free |
| Indications For Use: | |

A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

es ... .ption Use r 21 CFR 801.109 OR

Over-The-Counter

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