STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

K102500 · Cardinal Health, Inc. · KGO · Nov 4, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102500
• Device Name: STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Nov 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating 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.

Device Story

Disposable sterile surgical gloves made of synthetic neoprene rubber with nitrile coating. Worn by operating room personnel to provide a barrier protecting surgical wounds from contamination. Used in hospital and healthcare facility environments. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data is required. Bench testing included primary skin irritation (non-irritating), guinea pig maximization (no sensitization), freedom from holes (21 CFR 800.20/ASTM D3577), and residual powder testing (ASTM D6124, <2mg/glove).

Technological Characteristics

Synthetic neoprene rubber with nitrile coating. Sterile, powder-free. Dimensions and physical properties meet ASTM D3577. Residual powder meets ASTM D6124. No electronic components or software.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination in hospital and healthcare facility environments.

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

• Sterile Synthetic Neoprene Powder-Free Surgical Gloves (K013302)

Submission Summary (Full Text)

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CardinalHealth

NOV - 4 2010

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS K /0 25 OO

## STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

| Manufacturer: | Cardinal Healthcare 222 LTD.<br>7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng,<br>Rayong, 21140, Thailand |
|-----------------------------|-------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Tatyana Bogdan, RAC |

Regulatory Affairs Contact: Tatyana Bogdan, RAC Cardinal Health, Inc. 1430 Waukegan Road McGaw Park, IL 60085

| Telephone: | 847-887-2325 |
|------------|--------------|
|------------|--------------|

July 15, 2010 Date Summary Prepared:

Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Product Trade Name: Coating

Common Name: Surgeon's Gloves

Surgeon's Gloves Classification Name:

Gloves are formulated using neoprene. They are coated with nitrile Device Description: coating and are offered powder-free and sterile.

- · Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Intended Use: Coating 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.
- Sterile Synthetic Neoprene Powder-Free Surgical Gloves Predicate Devices: previously cleared under 510(k) K013302 (product code KGO);

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## K102500

| Substantial Equivalence: | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile<br>Coating are substantially equivalent to the predicate device<br>identified in this 510(k) summary. Substantial equivalence can be<br>established in regard to intended use, physical characteristics,<br>design and product features. Both gloves are made of neoprene and<br>are coated with Nitrile. They use similar manufacturing processes. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Physical Characteristics | Gloves meet requirements for rubber surgical gloves per ASTM<br>D3577. |

Gloves meet requirements of 21 CFR 800.20 and ASTM D3577 Freedom from Holes

Gloves meet powder level requirements for "Powder-Free" Powder Residual designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical Doves. Results generated values below 2mg of residual powder per glove.

No clinical data is required. Clinical Data:

. .

______________________________________________________________________________________________________________________________________________________________________________

The Synthetic Neoprene Powder-Free Surgical Gloves with Nitrile Conclusion: The Dynaneet the technological characteristics of ASTM D3577 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.

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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 features a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096

NOV - 4 2010

Re: K102500

Trade/Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 20, 2010 Received: October 21, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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/CDRHOffices/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,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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NoV . - 4 2010

## Indications for Use

510(k) Number (if known): )</02500

Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Device Name:

These powder-free sterile surgeon's gloves are a disposable device made Indications for Use: 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)

E. Elizabeth R. Levine-Walls

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

510(k) Number: K 102500

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

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