PROTEGRITY SMT LATEX SURGICALGLOVES

K101811 · Cardinal Health, Inc. · KGO · Oct 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101811
• Device Name: PROTEGRITY SMT LATEX SURGICALGLOVES
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural 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

Sterile, powder-free, brown-colored surgeon's gloves; manufactured from natural rubber latex with nitrile coating. Intended for use by operating room personnel to provide a barrier against contamination of surgical wounds. Device is disposable. Performance verified against ASTM D3577 standards for physical characteristics, dimensions, and freedom from holes. Protein content limited to 50µg/dm² or less per ASTM D5712. Biocompatibility confirmed via primary skin irritation and sensitization testing.

Clinical Evidence

No clinical data is required. Bench testing included primary skin irritation, Guinea Pig Maximization for sensitization, dimensions, physical characteristics, freedom from holes (21 CFR 800.20), powder residual (ASTM D6124), and protein content (ASTM D5712). All results met ASTM D3577 requirements.

Technological Characteristics

Natural rubber latex surgical gloves with nitrile coating; powder-free; sterile. Dimensions and physical properties conform to ASTM D3577. Protein content ≤ 50 µg/dm² (ASTM D5712). Residual powder < 2mg/glove (ASTM D6124).

Indications for Use

Indicated for use by operating room personnel in hospitals and healthcare facilities to protect surgical wounds from contamination. Disposable device.

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

• Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim (50 micrograms or less) (K992171)

Submission Summary (Full Text)

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K101811/5001

OCT 1 5 2010 Page of _

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

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

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

Cardinal Healthcare 222 LTD. Manufacturer: 7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand

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

847-887-2325 Telephone:

May 15, 2010 Date Summary Prepared:

Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating Product Trade Name: with Protein Content Label Claim of 50ug/dm- or less

- Surgeon's Gloves Common Name:
Surgeon's Gloves Classification Name:

Device Description: Sterile Latex Powder-Free Surgical gloves are formulated using natural rubber latex. They are coated with nitrile coating and are offered powder-free and sterile. The gloves are brown in color.

- These powder-free sterile brown color surgeon's gloves with Nitrile Intended Use: coating are a disposable device made of natural 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.

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K101811/5001

| Predicate Devices: | Coated Sterile Latex Powder-Free Surgical Gloves with Protein<br>-Content-Label-Claim-(50-micrograms-or-less)-previously-cleared ----<br>under 510(k) K992171 (product code KGO); |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating<br>with Protein Content Label Claim of 50µg/dm² or less are substantially<br>equivalent to the predicate device identified in this 510(k)<br>summary. Substantial equivalence can be established in regard to<br>intended use, physical characteristics, design and product features.<br>Both gloves are made of natural rubber latex using similar<br>manufacturing process. |
| 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. |
| 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. |
| Protein Content | Gloves have been tested in accordance with ASTM D5712 and<br>yielded the results of less than 50 µg/dm² of total water extractable<br>protein per glove |
| Clinical Data: | No clinical data is required. |
| Conclusion: | The Sterile Latex Powder-Free Surgical Gloves with Nitrile<br>Coating and Protein Content Label Claim of 50µg/dm² or less meet<br>the technological characteristics of ASTM D3577 performance<br>standard and are substantially equivalent to the predicate device<br>identified in this 510(k) summary. |

:

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Public Health Service

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

### 0CT 1 5 2010

Re: K101811

Trade/Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating With Protein Content Label Claim of 50ug/dm2 or less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 29, 2010 Received: October 1, 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,

Nh 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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# K101811/5001

## Indications for Use

### OCT 1 5 2010

510(k) Number (if known): _

.

Device Name: Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating with Protein Content Label Claim of 50 ug/dm2 or less

Indications for Use: These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural 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)

Elizabeth F. Clavius-Wilson

(Division Sign-Off)

| Division of Anesthesiology | General Hospital |
|----------------------------|------------------|
| Infection Control, Devices | |

| 510(k) N | K101811 |
|----------|---------|
|----------|---------|

Cardinal Health, Inc.

Premarket Notification Submission – Traditional 510(k)

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