ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES

K092304 · Cardinal Health, Inc. · KGO · Sep 15, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092304
• Device Name: ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Esteem Ortho Polyisoprene Powder-Free Surgical Gloves are a disposable device made of synthetic rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Device Story

Disposable synthetic rubber surgical gloves; worn by operating room personnel; intended to protect surgical wounds from contamination in healthcare environments. Device functions as a physical barrier; manufactured from polyisoprene. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data was required. Bench testing included primary skin irritation, guinea pig maximization for sensitization, and physical property testing per ASTM D3577 and 21 CFR 800.20.

Technological Characteristics

Synthetic rubber (polyisoprene) surgical gloves; powder-free; sterile. Meets ASTM D3577 standards for dimensions, ultimate elongation, tensile strength, and freedom from holes. Residual powder levels <2mg per glove per ASTM D6124.

Indications for Use

Indicated for use by operating room personnel as a disposable barrier to protect surgical wounds from contamination in hospital and healthcare settings.

Regulatory Classification

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.

Predicate Devices

• Esteem Polyisoprene Powder-Free Surgical Gloves (K011721)
• Ultrafree Max Sterile Latex Powder-Free Surgical Gloves (K010862)

Submission Summary (Full Text)

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

K092304

SEP 1 5 2009

CardinalHealth

P102

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES

| Manufacturer: | Cardinal Healthcare 222 LTD.<br>7/111 Moo 4, Highway 3331 Mabyangporn Pluakdaeng,<br>Rayong, 21140, Thailand |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: Tatyana Bogdan, RAC | Cardinal Health, Inc.<br>1500 Waukegan Road<br>McGaw Park, IL 60085 |
| Telephone: | 847-578-2325 |
| Date Summary Prepared: | June 12, 2009 |
| Product Trade Name: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Predicate Devices: | 1) Esteem Polyisoprene Powder-Free Surgical Gloves previously<br>cleared under K011721 (product code KGO);<br>2) Ultrafree Max Sterile Latex Powder-Free Surgical Gloves<br>previously cleared under K010862 (product code KGO). |
| Device Description: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves are<br>formulated using synthetic rubber latex. They are offered powder-<br>free and sterile. |
| Intended Use: | Esteem Ortho Polyisoprene Powder-Free Surgical Gloves are a<br>disposable device made of synthetic rubber that is intended to be<br>worn by operating room personnel to protect a surgical wound<br>from contamination in the environments within hospitals and other<br>healthcare facilities. |
| Substantial Equivalence: | Esteem Ortho Polyisoprene Powder-Free Surgical gloves are<br>substantially equivalent to Esteem Polyisoprene Powder-Free<br>Surgical gloves in regard to intended use, sizes, design and product |

Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)

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

K092304
p2sf2

features; they both are made of synthetic rubber latex using similar manufacturing process and packaging.

Esteem Ortho Polyisoprene Powder-Free Surgical gloves are also substantially equivalent to Ultrafree Max Sterile Latex Powder-Free Surgical gloves in regard to physical characteristics, design and product features. Both gloves are intended for use as specialty orthopedic surgeon's gloves.

#### Performance Testing:

| Test: | Result: |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves do not display any potential for sensitization. |
| Dimensions | Gloves meet requirements of ASTM D3577. |
| Ultimate Elongation<br>& Tensile Strength | Gloves meet requirements for rubber surgical gloves per<br>ASTM D3577. |
| Freedom from Holes | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Gloves meet powder level requirements for "Powder-Free"<br>designation per ASTM D3577 tested using ASTM standard<br>D6124, Standard test method for residual powder on medical<br>gloves. Results generated values below 2mg of residual powder<br>per glove. |
| Clinical Data: | No clinical data was required. |
| Conclusion: | The Esteem Ortho Polyisoprene Powder-Free Surgical Gloves<br>meet the technological characteristics of ASTM D3577 and are<br>substantially equivalent to predicate devices identified in this<br>510(k) summary. |

Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k)

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

Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three parallel lines that curve upwards and to the right, with a small circle at the bottom.

## SEP = 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring MD 20993-0002

Cardinal Healthcare, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K092304

Trade/Device Name: Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 28, 2009 Received: August 31, 2009

#### 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. watson for
Susan Runner, D.D.S., M.A.

Acting Division 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 Cardinal Health logo. The logo consists of a stylized bird-like graphic above the text "CardinalHealth". The graphic is made up of several curved lines that resemble wings. The text is in a sans-serif font and is black.

# Indications for Use

510(k) Number (if known):

Device Name:

Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves

Indications for Use:

These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .

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

Shula T. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page of

510(k) Number: K092304