Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

K151778 · Cardinal Health 200, Inc. · KGO · Mar 24, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151778
• Device Name: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
• Applicant: Cardinal Health 200, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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

Device Story

Sterile, powder-free, hand-specific orthopedic surgical glove; manufactured from natural rubber latex; features hydrogel polymer coating, independent thumb design, and beaded, mechanically locking cuffs to prevent roll-down. Intended for single-use by operating room personnel during orthopedic, trauma, or reconstructive surgeries requiring a thicker barrier. Provides protection against contamination of surgical wounds. Device is non-sterile/sterile (as labeled) and disposable.

Clinical Evidence

No clinical data required. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-10), physical properties (ASTM D3577), freedom from holes (ASTM D5151), powder residual (ASTM D6124), protein content (ASTM D5712), and puncture resistance (AS/NZ 4179).

Technological Characteristics

Material: Natural rubber latex. Design: Hand-specific, independent thumb, beaded cuff, hydrogel polymer coating. Standards: ASTM D3577 (dimensions, physical properties, powder residual), ASTM D5151 (freedom from holes), ASTM D5712 (protein content), AS/NZ 4179 (puncture resistance). Biocompatibility: ISO 10993-10. Single-use, sterile.

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

• Protexis Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating (K111015)
• Triflex Orthopedic Sterile Surgeon's Glove (K903987)

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

March 24, 2016

Cardinal Health 200, LLC. Ms. Caroline Miceli Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K151778

Trade/Device Name: Cardinal Health 111 Sterile Latex 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: February 18, 2016 Received: February 22, 2016

Dear Ms. Caroline Miceli:

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

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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 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 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 Keith, M.S. Division 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) K151778

Device Name

Cardinal Health TM Sterile Latex Powder-Free Orthopedic Surgical Gloves With Hydrogel Coating

#### Indications for Use (Describe)

A surgeon's glove is a device made of natural 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 shows the Cardinal Health logo. The logo consists of a stylized red bird-like shape above the words "CardinalHealth" in a bold, sans-serif font. The bird shape is made up of several curved lines that suggest movement or flight.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

| Manufacturer: | Cardinal Health 200, LLC<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Summary Prepared: | March 23, 2016 |
| Product Trade Name: | Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical<br>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 |

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Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter capitalized and the rest in lowercase.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

| Predicate Devices: | K111015 – ProtexisTM Sterile Latex Powder-Free Surgical Gloves<br>with Hydrogel Coating |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K903987- TriflexTM Orthopedic Sterile Surgeon's Glove |
| Reason for 510(k)<br>Submission: | New device |
| Device Description: | The proposed device is a sterile latex powder-free surgical glove<br>that is formulated using natural rubber latex and is brown in color.<br>The glove is coated with hydrogel polymer coating. |
| | The glove is manufactured using molds that feature an independent<br>thumb and mechanically locking cuffs to help prevent cuff roll<br>down. They are offered powder-free and sterile. This glove is for<br>single use only. |
| | 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 surgeon's glove is a device made of natural rubber intended to be<br>worn by operating room personnel to protect a surgical wound<br>from contamination. |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate<br>devices identified in this 510(k) summary. Substantial equivalence<br>can be established in regard to intended use, physical properties<br>and characteristics, design and product features. All gloves are<br>made of natural rubber latex using similar manufacturing<br>processes. |

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Image /page/5/Picture/0 description: The image contains the logo for Cardinal Health. The logo features a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

| | New Device<br>Cardinal Health™<br>Sterile Latex Powder-<br>Free Orthopedic<br>Surgical Gloves with<br>Hydrogel Coating<br>(K151778) | Predicate Device 1<br>Protexis™ Sterile Latex<br>Powder-Free Surgical<br>Gloves with Hydrogel<br>Coating (K111015) | Predicate Device 2<br>Triflex™ Orthopedic<br>Sterile Surgeon's Glove<br>(K903987) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Characteristic | Sterile Latex Powder-<br>Free Orthopedic<br>Surgical Gloves with<br>Hydrogel Coating | Sterile Latex Powder-<br>Free Surgical Gloves<br>with Hydrogel Coating | Orthopedic Sterile<br>Latex Powdered<br>Surgeon's Glove |
| Material Composition | Natural Rubber Latex | 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<br>Hydrogel Polymer<br>Coating | Single Use<br>Sterile<br>Powder-free<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated<br>Hydrogel Polymer<br>Coating | Single Use<br>Sterile<br>Powdered<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff |
| Label Claim | • Latex<br>• Single Use<br>• Sterile<br>• Powder-free<br>• Hydrogel Coating<br>• Contains less than<br>50 µg/dm² of total<br>water extractable<br>protein per glove<br>• Puncture<br>Resistance $≥$ 5N | • Latex<br>• Single Use<br>• Sterile<br>• Powder-free<br>• Hydrogel Coating<br>• Contains less than<br>50 µg/dm² of total<br>water extractable<br>protein per glove | • Latex<br>• Single Use<br>• Sterile<br>• Powdered |
| | New Device<br>Cardinal Health™<br>Sterile Latex Powder-<br>Free Orthopedic<br>Surgical Gloves with<br>Hydrogel Coating<br>(K151778) | Predicate Device 1<br>Protexis™ Sterile Latex<br>Powder-Free Surgical<br>Gloves with Hydrogel<br>Coating (K111015) | Predicate Device 2<br>Triflex™ Orthopedic<br>Sterile Surgeon's Glove<br>(K903987) |
| Intended Use/<br>Indications for Use | Orthopedic Powder-<br>Free Surgeon's Glove | Powder-Free Surgeon's<br>Glove | Orthopedic Powdered<br>Surgeon's Glove |
| Dimensions &<br>Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | AQL meets 21CFR<br>800.20 & ASTM<br>D3577 requirements | AQL meets 21CFR<br>800.20 & ASTM<br>D3577 requirements | AQL meets 21CFR<br>800.20 & ASTM<br>D3577 requirements |
| Powder Residual | Meets requirements of<br>≤ 2.0 mg/glove for<br>Powder-Free<br>designation per ASTM<br>D3577 | Meets requirements of<br>≤ 2.0 mg/glove for<br>Powder-Free<br>designation per ASTM<br>D3577 | N/A |
| Protein Contents | Contains less than 50<br>µg/dm² of total water<br>extractable protein per<br>glove as tested per<br>ASTM D5712 | Contains less than 50<br>µg/dm² of total water<br>extractable protein per<br>glove as tested per<br>ASTM D5712 | N/A |
| Puncture Resistance | Puncture<br>Resistance ≥ 5N<br>as tested per AS/NZ<br>4179 | N/A | N/A |

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#### Performance Data

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Image /page/6/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized red bird-like design above the words "CardinalHealth" in black font. The bird design is made up of several curved lines that resemble feathers or wings.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

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Image /page/7/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized red bird-like design above the words "CardinalHealth" in black font. The bird design is made up of several curved lines that resemble feathers or wings.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

#### Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence Dorfo - Now Davia

| | | Performance Test Summarv-New Device | |
|--|-------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|
| | Company of the country of the finance of the finance of the finance and the first and the first and the first and | | |

| Characteristics | Standard/Test/FDA<br>Guidance | Results Summary |
|----------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | | |
| Primary Skin Irritation | ISO 10993-10 | Under conditions of the study,<br>gloves are non-irritating. |
| Guinea Pig<br>Maximization | ISO 10993-10 | Under the conditions of the<br>study, gloves do not display<br>any potential for sensitization. |
| Physical Characteristics: | | |
| Dimensions | ASTM D3577 | Meet requirements |
| Physical Properties | ASTM D3577 | Meet requirements for rubber<br>surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM<br>D3577 | Tested in accordance with<br>ASTM D5151 with acceptable<br>results |
| Powder Residual | ASTM D3577 tested using<br>ASTM standard D6124 | Gloves meet powder level<br>requirements for "Powder-<br>Free" designation. Results<br>generated values < 2mg of<br>residual powder per glove. |
| Protein Content | FDA Medical Glove Guidance<br>Manual, ASTM D5712 | Gloves yielded the results of<br>less than 50 µg/dm² of total<br>water extractable protein per<br>glove. |
| Puncture Resistance | AS/NZ 4179 | Tested in accordance with<br>AS/NZ with acceptable results |

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Image /page/8/Picture/0 description: The image features the Cardinal Health logo. The logo consists of a stylized red bird-like design above the company name. The company name, "CardinalHealth", is written in a bold, sans-serif font, with the first letter of each word capitalized.

Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

| Characteristic | Requirement | New Device | Predicate<br>Device 1 | Predicate<br>Device 2 |
|----------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | | Cardinal HealthTM<br>Sterile Latex<br>Powder-Free<br>Orthopedic<br>Surgical<br>Gloves with<br>Hydrogel<br>Coating<br>(K151778) | ProtexisTM<br>Sterile Latex<br>Powder-Free<br>Surgical<br>Gloves with<br>Hydrogel<br>Coating<br>(K111015) | TriflexTM<br>Orthopedic<br>Sterile<br>Surgeon's<br>Glove<br>(K903987) |
| Biocompatibility | ISO 10993-1 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Primary Skin<br>Irritation | ISO 10993-10 | Pass | Pass | Pass |
| Guinea Pig<br>Maximization | ISO 10993-10 | Pass | Pass | Pass |
| Dimensions | ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Physical Properties | ASTM D3577 | Meets<br>requirements | Meets<br>requirements | Meets<br>requirements |
| Freedom from 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 | N/A |
| Protein Content | ASTM D5712 | Pass | Pass | N/A |
| Puncture Resistance | AZ/NZ 4179 | Pass | N/A | N/A |

## Comparative Performance Information Summary

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Image /page/9/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter capitalized and the rest in lowercase.

Cardinal Health™Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K151778

## Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or Clinical Information:

Clinical Data is not required.

#### Conclusions Drawn from Non-Clinical Data:

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