PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES

K121897 · Cardinal Health, Inc. · KGO · Jul 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121897
• Device Name: PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable, sterile, powder-free surgeon's glove made of natural rubber latex. Features independent thumb and tapered, beaded, mechanically locking cuffs to reduce roll-down. Used by operating room personnel to protect surgical wounds from contamination. Device is hand-specific. Modification from predicate involves removal of colorant, resulting in cream-colored glove. Performance verified against ASTM D3577 standards for physical properties, freedom from holes, and protein content.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1, ISO 10993-10), physical properties, freedom from holes (ASTM D5151), powder residual (ASTM D6124), and protein content (ASTM D5712).

Technological Characteristics

Natural rubber latex; sterile; powder-free; hand-specific; beaded cuff; independent thumb. Meets ASTM D3577 for dimensions and physical properties. Protein content < 50 µg/dm². Biocompatibility per ISO 10993.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Disposable, sterile, powder-free, natural rubber latex glove.

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

• Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50ug/dm2 or less (Tan) (K120934)

Submission Summary (Full Text)

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# K121897

JUL 2 7 2012

# Cardinal Health

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

### PROTEXIS™ LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (CREAM)

(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)

Applicant:

Cardinal Health 1430 Waukegan Road McGaw Park, IL 60085

| Establishment Registration | |
|----------------------------|------------------------------------------|
| Number: | 1423537 |
| Regulatory Affairs | |
| Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | [e-mail] |

Summary Prepared: June 14, 2012

Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Cream)

Common Name: Surgeon's Gloves

Classification Name: Surgeon's Gloves

Classification Panel: General and Plastic Surgery

21 CFR 878.4460 Regulation:

Product Code(s): KGO

Legally marketed device(s)

to which equivalence Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50ug/dm2 or less (Tan) (510(k) K120934, product code KGO)

Reason for 510(k) Submission:

Device modification to remove colorant from glove formulation.

**Device Description:**

Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

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Intended Use:

.

This powder-free surgeon's glove is a disposable device made of natural This powater 1100 be worn by operating room personnel to protect a surgical wound from contamination.

| Summary of the technological characteristics of the device compared to the predicate device | | |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Characteristic | Modified Device | Original device (Predicate device cleared under K120934) |
| Material Composition | Sterile Latex Powder-Free Surgical Gloves with Protein Content Label<br>Claim of 50 µg/dm² or less (Cream) | Sterile Latex Powder-Free Surgical Gloves with Protein Content Label<br>Claim of 50 µg/dm² or less (Tan) |
| Material Composition | Natural Rubber Latex | Natural Rubber Latex |
| Design | Single Use<br>Sterile<br>Powder-free<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated | Single Use<br>Sterile<br>Powder-free<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated |
| Intended Use/<br>Indications for Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove |
| Dimensions &<br>Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | AQL meets 21CFR 800.20 & ASTM D3577 requirements | AQL meets 21CFR 800.20 & ASTM D3577 requirements |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 |
| Protein Contents | Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712 | Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712 |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE* | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Biocompatibility:<br>Primary Skin Irritation | ISO 10993-10 | Meet requirements |
| Guinea Pig Maximization | ISO 10993-10 | Meet requirements |
| Physical Characteristics: | | |

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| Dimensions | ASTM D3577 | | Meet requirements | | | | |
|----------------------------------------------------------|--------------------------|--------------------|----------------------------------------------|-----------------------------------------------|--|--|--|
| Physical Properties | ASTM D3577 | | Meet requirements for rubber surgical gloves | | | | |
| Freedom from Holes | 21 CFR 800.20 & | | Tested in accordance with ASTM D5151 with | | | | |
| | ASTM D3577 | | acceptable results | | | | |
| Powder Residual | ASTM D3577 tested | | Gloves meet powder level requirements for | | | | |
| | using ASTM standard | | "Powder-Free" designation per ASTM | | | | |
| | D6124 | | | D3577. Results generated values < 2mg of | | | |
| | | | residual powder per glove. | | | | |
| Protein Content | ASTM D5712, FDA | | Gloves yielded the results of less than 50 | | | | |
| | Medical Glove | | | ug/dm2 of total water extractable protein per | | | |
| | glove<br>Guidance Manual | | | | | | |
| Comparative Performance Information Summary | | | | | | | |
| Characteristic | Requirement | Modified Device | | Original Device | | | |
| Biocompatibility: | ISO 10993-1 | Meets requirements | | Meets requirements | | | |
| Primary Skin Irritation | ISO 10993-10 | Meets requirements | | Meets requirements | | | |
| Guinea Pig | ISO 10993-10 | Meets requirements | | Meets requirements | | | |
| Maximization | | | | | | | |
| Dimensions | ASTM D3577 | Meets requirements | | Meets requirements | | | |
| Physical Properties | ASTM D3577 | Meets requirements | | Meets requirements | | | |
| Freedom from Holes | 21CFR800.20, | Meets requirements | | Meets requirements | | | |
| | ASTM D3577 | | | | | | |
| Powder Residual | ASTM D3577 | Meets requirements | | Meets requirements | | | |
| Protein Content | ASTM D5712 | Meets requirements | | Meets requirements | | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | | | | | | | |
| SURSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | | | | | |

Clinical data is not required.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

Non-clinical data demonstrates that Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of less than 50 µg/dm² (Cream) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performs as well as the legally marketed predicate devices identified in this summary.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

JUL 2 7 2012

Ms. Tatyana Bogdan-Curvin Regulatory Affairs Manager Cardinal Health, Incorporated 1430 Waukegan Road McGaw Park, Illinois 60085

- Re: K121897
Trade/Device Name: Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 ug/dm2 or less (Cream) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 14, 2012 Received: June 29, 2012

Dear Ms. Bogdan-Curvin:

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 ffor 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- Ms. Bogdan-Curvin

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 Stetson

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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Image /page/5/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 composed of several curved lines that converge at a central point, resembling a bird in flight or a stylized medical symbol. The text "CardinalHealth" is written in a bold, sans-serif font, with the two words joined together.

## Indications for Use

K121897

510(k) Number (if known):

Device Name:

Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 ug/dm2 or less (Cream)

Indications for Use:

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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)

Edi.let S. Lamino- I.V.V.

(Division Sign-Off) oncurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospita Infection Control, Dental Devices

510(k) Number: 1 >18 9 / Page of

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

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