Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

K160875 · Cardinal Health, Inc. · KGO · Jul 11, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160875
• Device Name: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A powder-free sterile 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

Disposable, sterile, powder-free orthopedic surgical glove; manufactured from synthetic polyisoprene rubber; features hydrogel polymer coating, anti-slip finish, independent thumb, and mechanically locking cuffs to prevent roll down. Used by operating room personnel (surgeons, nurses, technicians) during orthopedic, trauma, and reconstructive procedures. Provides a physical barrier to protect surgical wounds from contamination. Single-use only.

Clinical Evidence

Bench testing only. No clinical data required. Testing included biocompatibility (ISO 10993-10), physical properties, dimensions, freedom from holes (ASTM D5151/21 CFR 800.20), and powder residual (ASTM D6124), all meeting ASTM D3577 standards.

Technological Characteristics

Synthetic polyisoprene rubber; hydrogel polymer coating; hand-specific design with independent thumb and beaded cuff. Meets ASTM D3577 (physical properties, dimensions, powder residual) and 21 CFR 800.20 (freedom from holes). Biocompatibility per ISO 10993-10. Sterile, single-use.

Indications for Use

Indicated for use by operating room personnel as a protective barrier for surgical wounds during orthopedic, trauma, and reconstructive surgical procedures.

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 Ortho Polyisoprene Powder-Free Surgical Sterile Gloves (K092304)
• Sterile Latex Powder-Free Surgical Orthopedic Gloves with Hydrogel Coating (K151778)

Submission Summary (Full Text)

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

July 11, 2016

Cardinal Health, Inc. Ms. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Rd Waukegan, IL 60085

Re: K160875

Trade/Device Name: Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 9, 2016 Received: June 13, 2016

Dear Ms. Middaugh:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K160875

Device Name

Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

Indications for Use (Describe)

A powder-free sterile 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image features the logo for Cardinal Health. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that converge to a point, resembling a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com

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### 510(k) SUMMARY

### Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

| Manufacturer: | Cardinal Health 200, LLC<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Summary Prepared: | June 9, 2016 |
| Product Trade Name: | Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic<br>Surgical Gloves with Hydrogel Coating |
| Common Name: | Orthopedic Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code: | KGO |
| Predicate Devices: | 1) Esteem Ortho Polyisoprene Powder-Free Surgical Sterile<br>Gloves previously cleared under K092304 on September 15,<br>2009<br><br>2) Sterile Latex Powder-Free Surgical Orthopedic Gloves with<br>Hydrogel Coating cleared under K151778 on March 24, 2016 |
| Reason for 510(k)<br>Submission: | New device |
| Device Description: | The proposed device is a disposable device. It is not made with<br>natural rubber latex. Instead, the gloves are formulated using<br>polyisoprene, which is a synthetic rubber latex, and is brown in<br>color. The glove is coated with hydrogel polymer coating.<br><br>The gloves are manufactured using molds that feature anti-slip<br>finish, independent thumb and mechanically locking cuffs to help<br>prevent cuff roll down. They are offered powder-free and sterile.<br>This glove is for single use only.<br><br>This glove is suitable for use as a specialty surgical glove intended<br>for orthopedic procedures or other procedures where a thicker<br>barrier may be desired such as trauma and reconstructive surgery |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable device<br>made of synthetic rubber intended to be worn by operating room<br>personnel to protect a surgical wound from contamination. |
| Substantial Equivalence: | Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic<br>Surgical Gloves with Hydrogel Coating are substantially<br>equivalent to Esteem Ortho Polyisoprene Powder-Free Surgical<br>Sterile Gloves and the Sterile Latex Powder-Free Surgical<br>Orthopedic Gloves with Hydrogel Coating in regards to intended<br>use, sizes, physical characteristics, design and product features. All<br>three gloves are intended for use as specialty orthopedic surgeon's<br>gloves |

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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like symbol above the words "CardinalHealth" in a bold, black font. The bird symbol is made up of several curved lines that resemble feathers or wings.

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## 510(K) SUMMARY (CONT'D)

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## Table 1: Summary of Technological Characteristics

| Summary of the technological characteristics of the device compared to the predicate devices | | | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | New Device<br>Cardinal Health™ Sterile Polyisoprene Powder-Free<br>Orthopedic Surgical Gloves with Hydrogel Coating | Predicate Device<br>Esteem Ortho Polyisoprene Powder-Free<br>Surgical Sterile Gloves<br>(K092304) | Predicate Device<br>Sterile Latex Powder-Free Surgical<br>Orthopedic Gloves with Hydrogel Coating<br>(K151778) |
| Material Composition | Synthetic Polyisoprene coated with Hydrogel polymer | Synthetic Polyisoprene | Natural Rubber Latex coated with Hydrogel |
| Design | Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated<br>Polymer Coating | Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated | Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated<br>Polymer Coating |
| Intended Use /<br>Indication for Use | Powder-Free Orthopedic Surgeon's Glove | Powder-Free Orthopedic Surgeon's Glove | Powder-Free Orthopedic Surgeon's Glove |
| Label Claims | Sterile<br>Powder-free<br>Polyisoprene Surgical Glove with Hydrogel Coating<br>Not made with natural rubber latex<br>Single Use Only<br>Orthopedic<br>AQL 0.65 (Freedom from Holes per ASTM D5151) | Sterile<br>Powder-free<br>Not made with natural rubber latex<br>For Single Use Only<br>Orthopedic | Sterile<br>Powder-free<br>Latex Surgical Glove with Hydrogel<br>Coating<br>Single Use Only<br>Orthopedic<br>AQL 0.65 (Freedom from Holes per ASTM<br>D5151) |
| Dimensions &<br>Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets 21CFR 800.20 & ASTM D3577 requirements<br>of AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577<br>requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577<br>requirements of AQL 1.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for Powder-<br>Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for<br>Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for<br>Powder-Free designation per ASTM D3577 |
| Biocompatibility<br>(Irritation, ISO<br>10993-0:2010;<br>Sensitization, ISO<br>10993-10: 2010) | Non-Irritating, under the conditions of the study<br>Non-sensitizing, under the conditions of the study | Non-Irritating, under the conditions of the study<br>Non-sensitizing, under the conditions of the<br>study | Non-Irritating, under the conditions of the<br>study<br>Non-sensitizing, under the conditions of the<br>study |

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### Table 2: Summary of Non-Clinical Tests

| PERFORMANCE DATA | | |
|-----------------------------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION<br>OF SUBSTANTIAL EQUIVALENCE | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary |
| Biocompatibility: | | |
| Primary Skin<br>Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the study |
| Guinea Pig<br>Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Physical Characteristics: | | |
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meet requirements for synthetic surgical<br>gloves |
| Freedom from Holes | 21 CFR 800.20 &<br>ASTM D3577 | Tested in accordance with ASTM D 5151<br>and meets 21CFR 800.20 & ASTM<br>D3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577 tested<br>using ASTM<br>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. |

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| Comparative Performance Information Summary | | | | |
|---------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Requirement | New Device<br>Cardinal HealthTM<br>Sterile Polyisoprene<br>Powder-Free<br>Orthopedic Surgical<br>Gloves with<br>Hydrogel Coating | Predicate Device<br>Esteem Ortho<br>Polyisoprene<br>Powder-Free<br>Surgical Sterile<br>Gloves (K092304) | Predicate Device<br>Sterile Latex<br>Powder-Free<br>Surgical Orthopedic<br>Gloves with<br>Hydrogel Coating<br>(K151778) |
| Biocompatibility: | ISO 10993-1 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Primary Skin<br>Irritation | ISO 10993-10 | Non-Irritating,<br>under the<br>conditions of the<br>study | Non-Irritating,<br>under the<br>conditions of the<br>study | Non-Irritating,<br>under the<br>conditions of the<br>study |
| Guinea Pig<br>Maximization | ISO 10993-10 | Non-sensitizing,<br>under the<br>conditions of the<br>study | Non-sensitizing,<br>under the<br>conditions of the<br>study | Non-sensitizing,<br>under the<br>conditions of the<br>study |
| Dimensions | ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Physical<br>Properties | ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Freedom from<br>Holes | 21CFR800.20,<br>ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Powder Residual | ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |

### Table 3: Summary of Comparative Performance

### 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 DATA

Non-clinical data demonstrates Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performs as well as the legally marketed devices identified in this summary.