SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE

K011713 · Kimberly-Clark Corp. · LZA · Jul 5, 2001 · General Hospital

Device Facts

• Record ID: K011713
• Device Name: SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
• Applicant: Kimberly-Clark Corp.
• Product Code: LZA · General Hospital
• Decision Date: Jul 5, 2001
• 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

Safeskin Neon Nitrile is a powder-free patient examination glove. Worn on hands by healthcare and similar personnel to serve as a protective barrier; prevents contamination between personnel and patients. Device is a passive physical barrier; no active components or software. Used in clinical or similar settings. Benefits include reduction of cross-contamination risk during patient examinations.

Clinical Evidence

Bench testing only. No clinical data required for examination gloves. Compliance with ASTM D 3578-00, ASTM D 5151-99, and ASTM D 6124-00 standards demonstrated.

Technological Characteristics

Nitrile examination glove; powder-free. Meets ASTM D 3578-00 (dimensions, physical properties, powder content), ASTM D 5151-99 (pinholes), and ASTM D 6124-00 (powder residue). Biocompatible (passes primary skin irritation and guinea pig sensitization).

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

• poly-coated purple nitrile examination glove 80 LZA

Submission Summary (Full Text)

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

# 3 Kimberly-Clark

K011713

### JUL - 5 2001

May 31, 2001

- 510(k) Summary of Safety and Effectiveness Information [1]
- [2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076

| Telephone: | 770-587-8000 |
|------------|--------------|
| Fax: | 770-587-7762 |

Contact: Marcia Johnson Telephone: [phone] Fax:

- [3] Trade Name: "Safeskin Neon Nitrile" -- Powder Free Neon Nitrile Exam Glove Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate device is a Class I, poly-coated purple nitrile examination glove 80 LZA that meets all of the requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application (with the exception of elongation).
- [૨] The powder free neon nitrile exam glove will meet all of the requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application (with the exception of elongation).
- [୧] The powder free neon nitrile exam glove is a medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

G2

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

#### Professional Health Care

## 3 Kimberly-Clark

- The powder free neon nitrile exam glove possesses the following technological [7] characteristics (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|----------------------------------------------|----------------------------------------------|
| Dimensions | Meets ASTM D 3578-00 |
| Physical Properties<br>(except % elongation) | Meets ASTM D 3578-00 |
| Freedom from pinholes | Meets ASTM D 3578-00<br>Meets ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-00<br>Meets ASTM D 3578-00 |

Biocompatability

| 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.
Clinical data are not needed for examination gloves. [9]

- It can be concluded that the powder free neon nitrile exam glove will perform [10] according to the glove performance standards referenced in Section 7 above and therefore will meet FDA requirements and the labeling claims for the product. In addition, this device is substantially equivalent to currently marketed devices.
G3

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

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 or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2001

Ms. Marcia Johnson Senior Regulatory Associate Kimberely-Clark Corporation 1400 Holcomb Bridge Road Boswell, Georgia 30076

Re : K011713 Safeskin Neon Nitrile- Powder Trade/Device Name: Free Neon Examination Gloves Requlation Number: 880.6250 Requlatory Class: I Product Code: LZA Dated: May 31, 2001 June 4, 2001 Received:

Dear Ms. Johnson:

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 legally marketed predicate 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.

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

Page 2 - Ms. Johnson

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 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 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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

Enclosure

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

### INDICATIONS FOR USE

Kimberly-Clark Corporation Applicant:

510(k) Number:

Device Names:

KO11713

Powder Free Neon Nitrile Exam Glove

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

Qiss S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

B2