PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES

K111878 · Cardinal Health, Inc. · KGO · Sep 29, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111878
• Device Name: PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

This powder-free 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 natural rubber latex surgical glove with nitrile coating and Neu-Thera emollient coating (Glycerol, Gluconolactone, D-Sorbitol, Provitamin-B). Features anti-slip finish, independent thumb, and tapered mechanically locking cuffs to reduce roll-down. Used by operating room personnel to protect surgical wounds from contamination. Provides barrier protection during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-10), physical properties (ASTM D3577), freedom from holes (ASTM D5151), powder residual (ASTM D6124), and protein content (ASTM D5712).

Technological Characteristics

Natural rubber latex base with nitrile coating; emollient coating (Glycerol, Gluconolactone, D-Sorbitol, Provitamin-B). Design: hand-specific, beaded cuff, independent thumb, anti-slip finish. Standards: ASTM D3577 (physical properties/dimensions), ASTM D5151 (freedom from holes), ASTM D6124 (powder residual), ASTM D5712 (protein content). Biocompatibility per ISO 10993-1/10. Sterile.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Intended for over-the-counter use.

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

• Protegrity® Blue Sterile Powder-Free Latex/Nitrile Surgical Gloves with Neu-Thera Coating (K053272)

Submission Summary (Full Text)

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K111878

SEP 2 9 2011

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 made up of several curved lines that converge and overlap. The text "CardinalHealth" is written in a bold, sans-serif font.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS For STERILE LATEX WITH NITRILE COATING POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA COATING

(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 | |

| 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, 2011 Protexis™ Latex Blue with Neu-Thera® Surgical Gloves Trade Name: 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 Protegrity® Blue Sterile Powder-Free Latex/Nitrile Surgical Gloves with Neu-Thera Coating and with Protein Content Label Claim of 50 is claimed: micrograms or less (510(k) K053272, product code KGO) Reason for 510(k) Modification of a legally marketed device Submission:

Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, 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 rubber intended to 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 (Predicate) |
| Characteristic | Sterile Latex with Nitrile Coating<br>Powder-Free Blue Surgical Gloves<br>with Neu-Thera Coating | Protegrity Blue Sterile Latex/Nitrile<br>Powder-Free Surgical Glove with<br>Neu-Thera Coating (K053272) |
| Material<br>Composition | Natural Rubber Latex coated with<br>Nitrile | Natural Rubber Latex coated with<br>Nitrile |
| 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 |
| Coating<br>Contents | Provitamin B, Gluconolactone, D-<br>Sorbitol and Glycerol | Chitosan, Provitamin B,<br>Gluconolactone, D-Sorbitol and<br>Glycerol |
| 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<br>Holes | AQL meets 21CFR 800.20 &<br>ASTM D3577 requirements | AQL meets 21CFR 800.20 & ASTM<br>D3577 requirements |
| Powder Residual | Meets requirements of ≤2.0<br>mg/glove for Powder-Free<br>designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove<br>for Powder-Free designation per<br>ASTM D3577 |
| Protein Contents | Contains less than 50 $ \mu g/dm^2 $ of<br>total water extractable protein per<br>glove as tested per ASTM D5712 | Contains less than 50 $ \mu g/dm^2 $ of total<br>water extractable protein per glove as<br>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<br>Guidance | Results Summary |
| Biocompatibility:<br>Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. |
| Guinea Pig | ISO 10993-10 | Gloves do not display any potential for |

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

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## K/11878

| Maximization | sensitization. | | | |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--|
| Physical<br>Characteristics: | | | | |
| Dimensions | ASTM D3577 | Meet requirements | | |
| Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves | | |
| Freedom from Holes | 21 CFR 800.20 &<br>ASTM D3577 | Tested in accordance with ASTM D5151<br>with acceptable results | | |
| Powder Residual | ASTM D3577 tested<br>using ASTM standard D6124 | Gloves meet powder level requirements for<br>"Powder-Free" designation per ASTM<br>D3577. Results generated values < 2mg of<br>residual powder per glove. | | |
| Protein Content | ASTM D5712, FDA<br>Medical Glove<br>Guidance Manual | Gloves yielded the results of less than 50<br>µg/dm² of total water extractable protein per<br>glove | | |
| Comparative Performance Information Summary | | | | |
| Characteristic | Requirement | New Device | Predicate Device | |
| Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements | |
| Primary Skin Irritation | ISO 10993-10 | Pass | Pass | |
| Guinea Pig<br>Maximization | ISO 10993-10 | Pass | Pass | |
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements | |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements | |
| Freedom from Holes | 21CFR800.20,<br>ASTM D3577 | Meets requirements | Meets requirements | |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements | |
| Protein Content | ASTM D5712 | Pass | Pass | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | | |
| Clinical data is not required. | | | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | | | |
| Non-clinical data demonstrates that Sterile Latex with Nitrile Coating Powder-Free Blue Surgical | | | | |
| Gloves with Neu-Thera Coating and with Protein Content Label Claim (50 micrograms or less) | | | | |
| meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and | | | | |

meet the technological characteristics of ASTM D3577 standard, and are as sa
performed as well as the legally marketed devices identified in this summary.

.

.

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Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The graphic consists of three parallel, angled lines that resemble a bird in flight. The text around the border is small and difficult to read, but appears to be in a circular arrangement. The logo is black and white and has a slightly grainy texture.

Food and Drug Administration 10963 New Hampshire Avenue Document Control Room -WO(66-(160) Silver Spring, MD 20993-0002

Tatyana Bogdan Regulatory Affairs Manager Cardinal Health, Incorporated 1430 Waukegan Road Megaw Park, Illinois 60085

SEP 2 9 2011

Re: K111878

Trade/Device Name: Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating with Protein Content Labeling Claim of 50 Micrograms, or less Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: 1 Product Code: KGO Dated: August 02, 2011 Received: August 8, 2011

Dear Ms. Boudan:

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 provice 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 grement 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 lightlity 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 affective 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

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/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference 10 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 Biometries/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 vours.

Th 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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Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of three curved lines above the text "CardinalHealth". The lines are arranged in a way that suggests movement or flight. The text is in a bold, sans-serif font.

## Indications for Use

510(k) Number (if known): ___K111878

Protexis 110 Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating Device Name: with Protein Content Labeling Claim of 50 micrograms, or less

Sterile Latex with Nitrile Coating Powder-Free Blue Surgical Gloves with Device description: Neu-Thera Coating (containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B) and with Protein Content Labeling Claim 50 micrograms, or less.

Indications for Use: This powder-free 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.

AND/OR

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Edith A. Laurie-Wills

111878

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

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