SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)

K991951 · Safeskin Corp. · LYZ · Jul 26, 1999 · General Hospital

Device Facts

• Record ID: K991951
• Device Name: SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
• Applicant: Safeskin Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves used by healthcare personnel to prevent cross-contamination between the wearer and the patient. The device acts as a physical barrier. It is used in clinical settings. The gloves are manufactured to meet ASTM D 5250-99 specifications for vinyl examination gloves, including requirements for dimensions, physical properties, and freedom from pinholes. The gloves are powder-free, meeting ASTM D 6124 standards (maximum 2 mg/glove). Biocompatibility is confirmed via primary skin irritation and guinea pig sensitization testing.

Clinical Evidence

No clinical data. Bench testing only. Performance supported by compliance with ASTM D 5250-99 (dimensions, physical properties, pinhole resistance) and ASTM D 6124 (powder-free limit). Biocompatibility testing (primary skin irritation in rabbits and guinea pig sensitization) passed.

Technological Characteristics

Synthetic (vinyl) material. Powder-free (ASTM D 6124, max 2 mg/glove). Meets ASTM D 5250-99 for dimensions and physical properties. Meets ASTM D 5151 for freedom from pinholes. Biocompatible (passes primary skin irritation and guinea pig sensitization).

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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

• powder-free synthetic (vinyl) examination glove (K991951)

Submission Summary (Full Text)

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JUL 26 1999 June 9, 1999

K99 L9S]

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

Telephone: [phone] Fax: [phone]

Contact: Eugene V. Goorchenko Telephone: [phone] Fax:

- [3] Trade Name: Safeskin Synthetic Powder-Free Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a powder-free synthetic (vinyl) examination glove which meets all of the requirements of ASTM D 5250-99.
- [૨] The Safeskin Synthetic Powder-Free Examination Glove will meet all the current specifications for ASTM D 5250-99, vinyl examination gloves.
- [୧] Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] Safeskin® Synthetic Powder-Free Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|-----------------------------------------|
| Dimensions | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 |
| Freedom from pinholes | Meets ASTM D 5250<br>Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124<br>2 mg/glove maximum |

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Biocompatability

| Primary Skin Irritation in Rabbits | Passes |
|------------------------------------|--------|
| Guinea Pig Sensitization | Passes |

- The performance test data that support a determination of substantial equivalence [8] are described above.
- Clinical data are not needed for surgical gloves. [9]
- It can be concluded that the Safeskin® Synthetic Powder-Free Examination Glove [10] will perform according to the glove performance standards referenced in Section 7 above and therefore will meet 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 is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

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

Re : K991951 Safeskin Synthetic Vinyl Powder-Free Polymer Trade Name: Coated Examination Gloves (green, white) Requlatory Class: I Product Code: LYZ Dated: June 9, 1999 Received: June 10, 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 reqistration, listing of devices, qood 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 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.fdaf.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Directbr 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

Safeskin Corporation Applicant:

Kg91951 510(k) Number:

Device Name: Viral Synthetic powder-free examination glove of

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.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Over-The-Counter

Olin S. Lin

510(k) Number

9