SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG

K993117 · Safeskin Corp. · LYY · Mar 2, 2000 · General Hospital

Device Facts

• Record ID: K993117
• Device Name: SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
• Applicant: Safeskin Corp.
• Product Code: LYY · General Hospital
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable latex examination glove; serves as protective barrier for healthcare personnel; prevents cross-contamination between patient and provider; suitable for use with chemotherapeutic agents. Device is worn on hands; provides physical barrier. No electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing against ASTM standards for physical properties, pinhole freedom, and powder residue, plus biocompatibility testing (rabbit skin irritation and guinea pig sensitization).

Technological Characteristics

Latex material; powder-free (max 4 mg/glove per ASTM D 6124); dimensions and physical properties meet ASTM D 3578-99; freedom from pinholes meets ASTM D 5151. No energy source, connectivity, or software.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between personnel and patients, including use during handling of 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 powder free examination glove (unspecified 510(k))

Submission Summary (Full Text)

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FDA 510(k), Premarket Notification

MAR - 2 2000
K993117

Safeskin Corporation

September 1, 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: [phone] Fax:

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

- Trade Names: "Safeskin PFE-XTRA Latex Examination Glove" [3] Common Name: Patient Examination Glove Classification Name: Patient Examination Glove
- The predicate is a Safeskin powder free examination glove which meets all of the [4] requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application.
- [૨] The Safeskin PFE-XTRA Examination Glove will meet all the current specifications for ASTM D 3578-99.
- [୧] The Safeskin PFE-XTRA Examination Glove is a disposable device 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] The Safeskin PFE-XTRA Examination Glove posesses the following technological characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|-------------------------------------------|
| Dimensions | Meets ASTM D 3578-99 |
| Physical Properties | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 3578-99<br>Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124<br>4 mg/glove maximum |

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Biocompatability

Primary Skin Irritation in Rabbits Passes Passes Guinea Pig Sensitization

- [8] The performance test data that support a determination of substantial equivalence are described above.
- [a] Clinical data are not needed for examination gloves.
- [10] It can be concluded that the Safeskin PFE-XTRA Examination Glove is safe and 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 logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2000

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

Re : K993117

> Trade Name: Safeskin Pfe-xtra® Latex Examination Glove with Protein Labelinq Claim (50 microgram or less) Regulatory Class: I Product Code: LYY December 29, 1999 Dated: December 30, 1999 Received:

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 affectinq 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 Good Manufacturinq 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 requlation may result in requlatory 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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Paqe 2 -Mr. Goorchenko

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 diaqnostic 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

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE Applicant: Safeskin Corporation 510(k) Number (if known):

Device Namc:_Safeskin_PFE=XTRA_Powder=Free_Latex_Examination Glove With Protein Claim 50 mcg or less Indications For ! ِڪ:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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