POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

• K Number: K991317
• Device Name: POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
• Manufacturer: SAFESKIN CORP.
• Date Cleared: 1999-05-21 ( 32 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Safeskin® PFS PLUS powder-free latex 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.

AI/ML Overview

I am sorry, but I cannot provide information on the acceptance criteria or study details regarding the performance of the device based on the provided document. The document is a 510(k) summary and FDA clearance letter for a medical device (Safeskin® PFS PLUS powder-free latex surgical gloves), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data in the format of acceptance criteria and results.

Specifically, the document states:

• "[8] The performance test data that support a determination of substantial equivalence are described above." This refers to a general statement that the device "Meets ASTM D 3577 Dimensions," "Meets ASTM D 3577 Physical Properties," "Meets ASTM D 3577 Freedom from pinholes," "Meets ASTM D 5151 Powder-Free Less than 2 mg/glove," and "Passes Biocompatability Primary Skin Irritation in Rabbits" and "Passes Guinea Pit Sensitization." However, specific numerical acceptance criteria or the reported device performance values (e.g., exact dimensions, specific tensile strength, etc.) are not provided.
• "[9] Clinical data are not needed for surgical gloves." This indicates that no clinical study was conducted for this submission.

Therefore, I cannot extract the requested information like sample size, ground truth details, expert qualifications, or comparative effectiveness study results from this document.

Summary

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Image /page/0/Picture/0 description: The image shows the word "SAFESKIN" in bold, black letters. Above the word is a logo of a circle with two curved lines inside. To the right of the logo is the date "MAY 21 1999".

K991317

SAFESKIN CORPORATION 12671 High Bluff Drive SAN DIEGO, CALIFORNIA 92130 Tel: [phone] [phone] Fax: [phone]

April 16, 1999

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

619-509-7010 Telephone: [phone] Fax:

Eugene V. Goorchenko Contact: 619-509-7010 Telephone: Fax: [phone]

• Trade Name: Safeskin® PFS PLUS powder-free latex surgical gloves , [3] contains 5.0 mcg Surgical Gloves Common Name: water uf tra Classification Name: Surgeon's Gloves
• The predicate is a Safeskin® powder-free latex surgical glove which meets all of [4] the requirements of ASTM D 3577.
• The Safeskin® PFS Plus powder-free latex surgical glove will meet all the current ારો specifications for ASTM D 3577, rubber surgical gloves.
• Safeskin® PFS Plus powder-free latex surgical gloves are sterile disposable ાં રા devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
• Safeskin® PFS Plus powder-free latex surgical gloves possess the following [7] technological characteristics (as compared to ASTM or equivalent standards):

Standards Characteristics Meets ASTM D 3577 Dimensions

79

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Meets ASTM D 3577 Physical Properties Meets ASTM D 3577 Freedom from pinholes Meets ASTM D 5151 Meets ASTM D 6124 Powder-Free Less than 2 mg/glove Biocompatability Primary Skin Irritation in Rabbits Passes

• The performance test data that support a determination of substantial equivalence [8] are described above.
  Passes

• [9] Clinical data are not needed for surgical gloves.
  Guinea Pit Sensitization

• It can be concluded that the Safeskin® PFS Plus powder-free latex 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/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three horizontal lines above it, representing the branches of government. The seal is black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1999

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

Re : K991317 Safeskin® PFS PLUS powder-free latex Trade Name: surgeon's glove ,contains 50 mcgm or less of total water extractable protein per gram Regulatory Class: I Product Code: KGO Dated: April 16, 1999 Received: April 19, 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 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. ਚੋ 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 Reqister.

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Page 2 - Mr. Goorchenko

this response to your premarket notification Please note: 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 requlations.

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 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,

Susan Page

J. Stuart

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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INDICATIONS FOR USE

Safeskin Corporation Applicant: 510(k) Number: 长991317 Surgeon's glove PFS PLUS , Powder-Firer Pelym Device Name: Surgeon's glove "11 3 from water extree extractic blo

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)

Over-The-Counter

Olin S. Lòn

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

11

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
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.(b)
Classification. Class I (general controls).