SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM

K992162 · Safeskin Corp. · LZC · Aug 30, 1999 · General Hospital

Device Facts

• Record ID: K992162
• Device Name: SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
• Applicant: Safeskin Corp.
• Product Code: LZC · General Hospital
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Device Story

Disposable nitrile examination gloves; worn by healthcare personnel to provide barrier protection against contamination between patient and user; specifically tested for use with chemotherapeutic agents. Device functions as physical barrier; no electronic or mechanical components. Used in clinical settings; no specialized operation required. Benefits include protection of healthcare workers and patients from potential contaminants and exposure to chemotherapy drugs.

Clinical Evidence

No clinical data. Evidence consists of bench testing including physical property testing per ASTM D 6319-99, pinhole testing per ASTM D 5151, powder residue testing per ASTM D 6124, biocompatibility testing (primary skin irritation, guinea pig sensitization), and permeation testing with chemotherapeutic agents per ASTM F 739-96.

Technological Characteristics

Material: Nitrile. Form factor: Disposable examination glove. Powder-free (max 2 mg/glove per ASTM D 6124). Compliance: ASTM D 6319-99 (dimensions, physical properties), ASTM D 5151 (pinholes), ASTM F 739-96 (chemotherapeutic permeation).

Indications for Use

Indicated for healthcare and similar personnel to prevent cross-contamination between personnel and patients; also indicated for use with chemotherapeutic agents.

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

• Safeskin blue Nitrile Examination Glove

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "K992162 Safeskin Corporation". The text appears to be handwritten, with the "K992162" portion in a cursive style. Below the numbers, the words "Safeskin Corporation" are printed in a smaller, sans-serif font.

June 24, 1999

- 510(k) Summary of Safety and Effectiveness Information [1]
- [2] Safeskin Corporation 12671 High Bluff Drive San Diego, CA 92130

619-794-8111 Telephone: Fax: [phone]

| Contact: | Eugene V. Goorchenko |
|------------|----------------------|
| Telephone: | 619-509-7010 |
| Fax: | 619-350-2382 |

- [3] Trade Name: Safeskin Purple Nitrile Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a Safeskin blue Nitrile Examination Glove which meets all of the requirements of ASTM D 6319-99, Standard Specification for Nitrile Examination Gloves for Medical Application.
- [ર] The Safeskin Purple Nitrile Examination Glove will meet all the current specifications for ASTM D 6319-99.
- [୧] Safeskin Purple Nitrile Examination Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
- [7] Safeskin Purple Nitrile Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|-------------------------------------------|
| Dimensions | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99<br>Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124<br>2 mg/glove maximum |

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Image /page/1/Picture/1 description: The image shows the text "K992162" in a handwritten style. Below this, the words "Safeskin Corporation" are printed in a clear, legible font. The text is black against a white background, creating a high contrast image.

Biocompatability

| | Primary Skin Irritation in Rabbits | Passes |
|-----|-----------------------------------------------------------------------------------|----------------------|
| | Guinea Pig Sensitization | Passes |
| | Permeation Testing with | |
| | Chemotherapeutic Agents | Passes ASTM F 739-96 |
| [8] | The performance test data that support a determination of substantial equivalence | |

- [[]] are described above.
- (તે) Clinical data are not needed for examination gloves.
- It can be concluded that the Safeskin Purple Nitrile Examination Glove in safe and [10] effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing right, with a stylized bird above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. Eugene V. Goorchenko Director of Regulatory Affairs Safeskin Corporation 12671 High Bluff Drive San Diego, California 92130

K992162 Re : Safeskin Purple Powder-Free Nitrile Trade Name: Examination Gloves For Use With Chemotherapeutic Drugs Labeling Claim Regulatory Class: I Product Code: LZC Dated: June 24, 1999 Received: June 25, 1999

Dear Mr. Goorchenko:

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 aqainst 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. A 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Goorchenko

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 regulation (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,

Timothy A. Ulatowski

Timothy 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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## FDA 510(k), Premarket Notification

Safeskin Corporation

## INDICATIONS FOR USE

Applicant:

Safeskin Corporation

K992162

510(k) Number:

Device Name:

Purple Nitrile Patient Examination Glove for use with Chemotherapeutic Agents

Indications for Use:

A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Baud by Clin

of Dental, Infection Control, eneral Hospit i O{k} Number

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Over-The-Counter

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