STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING

K111868 · Cardinal Health-Medical Products and Services · KGO · Sep 21, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111868
• Device Name: STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
• Applicant: Cardinal Health-Medical Products and Services
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 21, 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 synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, disposable, powder-free surgical glove; manufactured from synthetic polyisoprene rubber. Features anti-slip finish, independent thumb, and tapered mechanically locking cuffs to prevent roll-down. Coated with emollient formulation containing Glycerol, Gluconolactone, D-Sorbitol, and Provitamin-B. Used by operating room personnel to provide a protective barrier between the wearer and the surgical site, reducing risk of wound contamination. Device is hand-specific and provided sterile.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (primary skin irritation, guinea pig maximization per ISO 10993-10) and physical performance testing (dimensions, physical properties, freedom from holes, and powder residual per ASTM D3577 and 21 CFR 800.20).

Technological Characteristics

Material: Synthetic polyisoprene rubber. Design: Hand-specific, beaded cuff, independent thumb. Coating: Glycerol, Gluconolactone, D-Sorbitol, Provitamin-B. Standards: Meets ASTM D3577 for physical properties and powder residual (≤2.0 mg/glove); meets 21 CFR 800.20 for freedom from holes. Sterilization: Sterile. Connectivity: None.

Indications for Use

Indicated for use by operating room personnel as a protective barrier for surgical wounds. No specific age or gender restrictions; intended for use in surgical 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

• Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating (K042574)

Submission Summary (Full Text)

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K111868

SEP 2 1 2011

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first word in red and the second word in black.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for STERILE POLYISOPRENE 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)

Cardinal Health Applicant: 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, 2011

| Trade Name: | Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Coating |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code(s): | KGO |
| Legally marketed device(s) to which equivalence is claimed: | Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating (containing Chitosan, Provitamin B5, Gluconolactone and Glycerol) cleared under 510(k) K042574 (product code KGO) |
| Reason for 510(k) Submission: | Modification of a legally marketed device |

Device Description: The proposed device is a disposable device intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and

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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. It is offered powder-free and sterile.

## Intended Use:

This powder-free surgeon's glove is a disposable device made of synthetic 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) |
| Material<br>Composition | Synthetic Rubber Latex -<br>Polyisoprene | Synthetic Rubber Latex -<br>Polyisoprene |
| | Sterile Polyisoprene Powder-Free<br>Blue Surgical Gloves with Neu-<br>Thera Coating | Esteem Blue Sterile Polyisoprene<br>Powder-Free Surgical Glove with<br>Neu-Thera Coating (K042574) |
| 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<br>Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove |
| Dimensions &<br>Physical<br>Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from<br>Holes | AQL meets 21CFR 800.20 & ASTM<br>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 |

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## PERFORMANCE DATA

## SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*

### Performance Test Summary-New Device

| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Biocompatibility:<br>Primary Skin Irritation<br>Guinea Pig<br>Maximization | ISO 10993-10<br>ISO 10993-10 | Gloves are non-irritating.<br>Gloves do not display any potential for<br>sensitization. | |
| Physical<br>Characteristics: | | | |
| Dimensions<br>Physical Properties<br>Freedom from Holes<br>Powder Residual | ASTM D3577<br>ASTM D3577<br>21 CFR 800.20 &<br>ASTM D3577<br>ASTM D3577 tested<br>using ASTM standard<br>D6124 | Meet requirements<br>Meet requirements for rubber surgical gloves<br>Tested in accordance with ASTM D5151<br>with acceptable results<br>Gloves meet powder level requirements for<br>"Powder-Free" designation per ASTM<br>D3577. Results generated values < 2mg of<br>residual powder per 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 |

# SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF 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 Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Coating meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and 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 circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a stylized human figure. The logo is black and white.

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

Ms. Tatyana Bogdan Regulatory Affairs Manager Cardinal Health-Medical Products and Services 1430 Waukegan Road McGaw Park, Illinois 60085

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Re: KI11868

Trade/Device Name: Esteem® Blue with Neu-Thera® Regulation Number: 21 CFR 878,4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: July 26, 2011 Received: July 27, 2011

Dear Ms. Bogdan:

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, Paris 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 /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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Contrition, Vi, and

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 three curved lines above the text "CardinalHealth". The lines are arranged in a way that they look like a bird in flight. The text is in bold and is in a sans-serif font.

Prescription Use

( F (Part 21 CFR 801 Subpart D)

# Indications for Use

510(k) Number (if known): K111868

Esteem® Blue with Neu-Thera® Device Name:

Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Device description: Coating (containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B)

Indications for Use: This powder-free surgeon's glove is a disposable device made of synthetic 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)