ESTEEM STRETCHY VINYL GLOVE WITH COATING

K052568 · Cardinalhealth · LYZ · Nov 28, 2005 · General Hospital

Device Facts

• Record ID: K052568
• Device Name: ESTEEM STRETCHY VINYL GLOVE WITH COATING
• Applicant: Cardinalhealth
• Product Code: LYZ · General Hospital
• Decision Date: Nov 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

A 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.

Device Story

Esteem Stretchy Synthetic with Neu-Thera is a disposable vinyl patient examination glove. Designed for use by healthcare professionals to prevent cross-contamination between patient and examiner. The device is worn on the hands or fingers during medical examinations. It is provided powder-free and features a beaded cuff. The glove serves as a physical barrier to protect both the patient and the clinician.

Clinical Evidence

Bench testing only. Testing included primary skin irritation and guinea pig maximization studies, which showed no irritation or sensitization potential. Physical performance testing confirmed compliance with ASTM D5250-00e4 for tensile strength and 21 CFR 800.20 for barrier defects.

Technological Characteristics

Vinyl material; powder-free; beaded cuff; disposable. Meets ASTM D5250-00e4 standards for tensile strength and barrier integrity. Complies with 21 CFR 800.20 for barrier defects.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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

• Vinyl Powder-Free Examination Gloves, Grand Work Plastic Products Co., Ltd.

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the text "CardinalHealth". The lines are arranged in a way that they appear to be converging towards a point on the right side of the image. The text is in a bold, sans-serif font.

## XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

## K052568

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VINYL POWDER-FREE EXAMINATION GLOVES WITH COATING

Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact: Amy Hoyd Cardinal Health 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone: [phone]

Fax: [phone]

Date Summary Prepared: 03 July 2005

Product Trade Name: Esteem Stretchy Synthetic with Neu-Thera

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Vinyl Powder-Free Examination Gloves, Grand Work Plastic Products Co., Ltd.

Description: Vinyl Powder-Free Examination Gloves with coating are formulated using Vinyl and offered powder-free.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

17

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

Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is made up of four curved lines that intersect each other. The text "CardinalHealth" is written in a sans-serif font.

K052568
payl of 2

K052568 Page 2

Substantial Equivalence: Esteem Stretchy Synthetic with Neu-Thera are substantially equivalent to Grand Work Plastic Products Co., Ltd s Vinyl Powder-Free Examination Gloves in that they provide the following characteristics:

- same intended usc
- same sizes
- both made of Vinyl
- both offered beaded and powder-free

## Summary of Testing:

| Test | Result |
|-------------------------|------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per<br>ASTM D5250-00e4. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20<br>and ASTM D5250-00e4. |

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2005

Cardinal Health C/O Mr. Neil Devine Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052568

Trade/Device Name: Esteem Stretchy Synthetic with Neu-Thera Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 21, 2005 Received: November 22, 2005

Dear Mr. Devine:

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.

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

Page 2 -- Mr. Devine

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/industry/support/index.html.

Sincerely yours,

Chih-Lin, Ph.D.

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

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

Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is made up of several curved lines that converge at a point, resembling a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 Phone [phone] Fax

| 510(k) Number: | K052568 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Esteem Stretchy Synthetic with Neu-Thera |
| Indications For Use: | A patient examination glove is a disposable deviceintended for medical purposes that is worn on theexaminer's hand or finger to prevent contaminationbetween patient and examiner. |

Prescription Use ( 21 CFR 801 Subpart D)

> : :

AND/OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela H. Humphrey MD 11/28/65

non (Sogn-Off) . . 4:00 Sign=On)
Prion of Anestheatulogy, General Hospital, ichsodon Control, Dantal Devices

Number: K 052508

Page 1 of