SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE

K031750 · Kimberly-Clark Corp. · LYZ · Oct 24, 2003 · General Hospital

Device Facts

• Record ID: K031750
• Device Name: SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
• Applicant: Kimberly-Clark Corp.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable powder-free vinyl examination glove; worn by healthcare personnel; acts as physical barrier to prevent cross-contamination between examiner and patient; used in clinical settings; provides protection during patient examinations.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical property, dimension, pinhole, and powder-free residue testing per ASTM standards, and biocompatibility testing per ISO 10993.

Technological Characteristics

Material: Poly(vinyl chloride) (vinyl). Standards: ASTM D 5250-00 (dimensions, physical properties, powder-free), ASTM D 5151-99 (pinholes), ASTM D 6124-01 (powder-free). Biocompatibility: ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity).

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hand to prevent contamination between the examiner 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.

Submission Summary (Full Text)

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SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove

OCT 2 4 2003

erly-Clark Corporation

FALTH CARE SECTOR 00 Holcomb Bridge Road oswell GA 30076-2199

Phone: [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

- 510(k) Summary of Safety and Effectiveness Information [1]
- Kimberly-Clark Corporation [2] 1400 Holcomb Bridge Road Roswell, GA 30076-2199 770-587-8000 Telephone: Fax: [phone]

Richard V. Wolfe Contact: Telephone: [phone] Fax: [phone]

- SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove (3) Trade Name: Common Name: Patient Examination Gloves, Vinyl Classification Name: Patient Examination Gloves, Vinyl
- The predicate device is a Class I, powder-free vinyl exam glove 80L YZ that meets all of the [4] requirements of ASTM D 5250-00, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam glove meets the current specifications of ASTM D 5250-00. [૨] "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare [6] and similar personnel to prevent contamination between such personnel and the patient.

Attachment H (page 1 of 2)

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## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Cont'd)

- The powder-free vinyl exam gloves possess the following technological characteristics (as [7] compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|----------------------------------------------|
| Dimensions | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 |
| Freedom from pinholes | Meets ASTM D 5250-00<br>Meets ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-01<br>Meets ASTM D 5250-00 |

Biocompatibility - Biocompatibility testing was conducted to the following parts of ISO 10993, "Biological Evaluation of Medical Devices":

- Part 10, "Tests for Irritation and Sensitization" ●
- Part 11, "Tests for Systemic Toxicity(ISO): ●

| Study Title | Test Animal | Results |
|---------------------------------------------|-------------|---------|
| ISO Skin Irritation Study | Rabbit | Passed |
| Murine Local Lymph Node Assay (LLNA) | Mouse | Passed |
| USP and ISO Systemic Toxicity Study Extract | Mouse | Passed |

- [8] The performance test data that support a determination of substantial equivalence are described above.
- ી છે Clinical data are not needed for examination gloves.
- It can be concluded that the powder-free vinyl exam glove is safe and effective and will [10] 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 exam glove is substantially equivalent to currently marketed exam gloves.

### Attachment H (page 2 of 2)

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape above them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

Mr. Richard V. Wolfe Manager, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re: K031750

Trade/Device Name: SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: LYZ Product Code: I Dated: August 14, 2003 Received: August 18, 2003

Dear Mr. Wolfe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Wolfe

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sina Runne

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/2 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "KC" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The logo is simple and professional, reflecting the company's established presence in the consumer goods industry.

HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199

Phone: [phone] Fax: [phone]

# DICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|----------------------|----------------------------------------------------------------------|
| 510(k) Number: | K031750 |
| Device Name: | SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove |
| Indications for Use: | Based upon 21CFR§880.6250 “Patient examination glove”: |
| | A patient examination glove is a medical device intended for medical |

A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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### Concurrence of CDRH Office of Device Evaluation (ODE)

Patrice Ari, Lisen Branch Chief, IMCS 10/23/6

Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K031752

OR

Prescription Use Per 21CFR 801.109 Over-The-Counter

Attachment C