SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE

K992830 · Safeskin Corp. · LZA · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K992830
• Device Name: SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
• Applicant: Safeskin Corp.
• Product Code: LZA · General Hospital
• Decision Date: Oct 27, 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.

Device Story

The Safeskin Polymer-Coated Nitrile Examination Glove is a sterile, disposable, powder-free glove. It is worn by healthcare and similar personnel to serve as a protective barrier, preventing contamination between the wearer and the patient. The device is used in clinical or similar settings. It functions as a physical barrier and is manufactured to meet specific physical property and biocompatibility standards.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing per ASTM D 3578-99, freedom from pinholes per ASTM D 5151, powder content per ASTM D 6124, and biocompatibility testing (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Nitrile material; powder-free (max 2 mg/glove); sterile; disposable. Meets ASTM D 3578-99 (dimensions, physical properties), ASTM D 5151 (pinholes), and ASTM D 6124 (powder content).

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

• Safeskin blue nitrile examination glove

Submission Summary (Full Text)

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001 27 1999

CONFIDENTIAL Safeskin Corporation

FDA 510(k), Premarket Notification

K982830

August 20, 1999

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

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

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

- Trade Names: "Safeskin Polymer-Coated Nitrile Examination Glove" and [3] Trade Names: "Saleskill Folyme", Powder-Free Patient Examination Gloves Common Name: Common Name: Patient Examination Gloves
- The predicate is a Safeskin blue nitrile examination glove which meets all of the The predicate is a Safeskin blue nitrue exammation glove in the least of the best in the Examination
requirements of ASTM D 3578-99, Standard Specification for Nitrile Examin [4] Gloves for Medical Application.
- The Safeskin Polymer-Coated Nitrile Examination Glove will meet the current of elongation). The Safeskin Polymer-Coated Nitrile Examination of elongation).
specifications for ASTM D 3578-99 (with the exception of elongation). [ર]
- The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable
s of the same of the collections and similar personnel to prevent The Safeskin Polymer-Coated Nitrile Loadmandinian personnel to prevent
devices intended to be worn by healthcare and similar personnel to prevent [୧] devices intended to be worn by systemnel and the patient.
- The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following
er of the finance of the founders and to ASTM or equivalent standards): [7] The Safeskin Polymer-Coated Nittle Exammared to ASTM or equivalent standards):
technological characteristics (as compared to ASTM or equivalent standards):
Stephological char Standards Characteristics Meets ASTM D 3578-99 Dimensions Meets ASTM D 3578-99 Physical Properties Meets ASTM D 3578-99 Freedom from pinholes Meets ASTM D 5151 Meets ASTM D 6124 Powder-Free 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 examination gloves. (a)
- It can be concluded that the Safeskin Polymer-Coated Nitrile Examination Glove [10] If can be concluded that the salessur Formance standards referenced in Section 7
will perform according to the glove performance standards charize also the will perform according to the glove periorments and the labeling claims for the above and therefore will his device is substantially equivalent to currently marketed devices.

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

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

Re : K992830

> Safeskin Polymer-Coated Nitrile Examination Trade Name: Gloves Regulatory Class: I Product Codc: LZA Dated: August 20, 1999 Received: August 23, 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 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 (Premarket Approval), 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 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. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Goorchenko

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 qeneral 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,

Clifford

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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Safeskin Corporation

FDA 510(k), Premarket Notification

## INDICATIONS FOR USE

Safeskin Corporation Applicant:

K 992830 510(k) Number:

Powder-free polymer-coated nitrile examination glove, purple or Device Names: whitc

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

Clim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 5100kt Number -

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