SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES

K994081 · Safeskin Corp. · KGO · Jan 18, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994081
• Device Name: SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
• Applicant: Safeskin Corp.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

Device Story

Safeskin Tactylon® PF powder-free surgical gloves are sterile, disposable devices worn by operating room personnel. The gloves act as a physical barrier to prevent cross-contamination between the wearer and the patient during surgical procedures. The device is used in clinical surgical settings. No complex processing or electronic output is involved; the device functions as a protective barrier.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical property, dimension, and pinhole testing per ASTM D 3577 and ASTM D 5151, and powder residue testing per ASTM D 6124. Biocompatibility testing (primary skin irritation and guinea pig sensitization) was performed and passed.

Technological Characteristics

Synthetic surgical glove; powder-free (max 2 mg/glove per ASTM D 6124); meets ASTM D 3577 for dimensions and physical properties; meets ASTM D 5151 for freedom from pinholes. Sterile, disposable.

Indications for Use

Indicated for use by operating room personnel to prevent contamination between personnel and patients during surgical procedures.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Safeskin powdered synthetic surgical glove

Submission Summary (Full Text)

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## 1994081

FDA 510(k), Premarket Notification

## JAN 1 8 2000

December 2, 1999

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

Telephone: [phone] Fax:

| Contact: | Eugene V. Goorchenko |
|------------|----------------------|
| Telephone: | 858-509-7010 |
| Fax: | 858-350-2382 |

- [3] Trade Name: Safeskin Tactylon® PF powder-free surgical gloves Surgical Gloves Common Name: Classification Name: Surgeon's Gloves
- The predicate is a Safeskin powdered synthetic surgical glove which meets all of [4] the requirements of ASTM D 3577.
- The Safeskin Tactylon® PF powder-free surgical glove will meet all the current [૨] specifications for ASTM D 3577, type 2 rubber surgical gloves.
- [୧] Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
- [7] Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|-----------------------------------------|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577 |
| Freedom from pinholes | Meets ASTM D 3577<br>Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124<br>2 mg/glove maximum |

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Biocompatibility

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

- [8] The performance test data that support a determination of substantial equivalence are described above.
- [9] Clinical data are not needed for surgical gloves.
- It can be concluded that the Safeskin® Tactylon PF powder-free surgical 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2000

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

Re: K994081

> Safeskin Tactylon® PF Powder Free Surgeon's Trade Name: Glove Requlatory Class: I Product Code: KGO Dated: December 2, 1999 Received: December 3, 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, 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. 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 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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## 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 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 oriece of compriand, "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: | K994081 | | |

Safeskin Tactylon® PF Powder Free Surgeon's Glove Device Name:

Indications for Use:

A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Ola S. Lim

Over-The-Counter

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K994081 |
|---------------|---------|
|---------------|---------|

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