SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES

K992062 · Safeskin Corp. · LZA · Aug 25, 1999 · General Hospital

Device Facts

• Record ID: K992062
• Device Name: SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
• Applicant: Safeskin Corp.
• Product Code: LZA · General Hospital
• Decision Date: Aug 25, 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

Sterile, powder-free nitrile examination gloves; intended for use by healthcare personnel to provide a protective barrier against contamination. Device is a disposable, single-use physical barrier. No electronic, software, or algorithmic components. Used in clinical settings to maintain hygiene and prevent cross-contamination between patients and staff.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing confirming compliance with ASTM D 6319-99 (dimensions, physical properties, freedom from pinholes) and ASTM D 6124 (powder-free status), alongside successful biocompatibility testing (primary skin irritation and guinea pig sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Sterile, powder-free examination glove. Standards: Meets ASTM D 6319-99 (dimensions, physical properties, freedom from pinholes), ASTM D 5151 (pinholes), and ASTM D 6124 (powder-free, max 2 mg/glove).

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)

{0}------------------------------------------------

K992062

Safeskin Corporation

June 17, 1999

- 510(k) Summary of Safety and Effectiveness Information [1]
- [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 Sterile Purple Nitrile Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a Safeskin Blue Nitrile Examination Glove which meets all of the requirements of ASTM D 6319-99, Standard Specification for Nitrile Examination Gloves for Medical Application.
- [5] The Safeskin Sterile Purple Nitrile Examination Glove will meet all the current specifications for ASTM D 6319-99.
- [୧] Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] Safeskin Sterile Purple Nitrile Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|----------------------|
| Dimensions | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99 |
| | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 |
| | 2 mg/glove maximum |

{1}------------------------------------------------

K992062

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 Sterile Purple Nitrile 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

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

K992062 Re : Safeskin Sterile Purple Nitrile Examination Trade Name: Gloves (Powder Free) Requlatory Class: I LZA Product Code: Dated: June 17, 1999 Received: June 18, 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. ਜੋ 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 obligation you might have under sections 531 through 542 of

{3}------------------------------------------------

Page 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 or bubbeanced cquesults in a classification for your device and thus, permits your device to proceed to the market. endb/ Delmire your device for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. 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 Other general information on your responsibilities CFR 807.97). 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,

Timothy A. Ulatowski

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

Enclosure

{4}------------------------------------------------

K92062

## FDA 510(k), Premarket Notification

Safeskin Corporation

## INDICATIONS FOR USE

Safeskin Corporation Applicant:

510(k) Number:

Sterile Purple Nitrile Patient Examination Glove Device Name:

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)

Chun S. Lin

(Division Sign-Off) Division of Dental, Infection Co and Ganeral Hospital 510lk) Number

Over-The-Counter

10