Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

K201592 · Cardinal Health200, LLC · KGO · Sep 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201592
• Device Name: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
• Applicant: Cardinal Health200, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

Device Story

Disposable, powder-free, synthetic rubber surgical gloves; worn by operating room personnel to provide barrier protection for surgical wounds. Device provides resistance to permeation of specific chemotherapy drugs. Selection of gloves requires review of drug labeling and material safety data for specific chemical compatibility. Benefits include reduced risk of wound contamination and protection against chemotherapy agent exposure during handling.

Clinical Evidence

Bench testing only; device tested for resistance to permeation of chemotherapy drugs per ASTM D6978.

Technological Characteristics

Synthetic rubber material; powder-free; disposable; tested per ASTM D6978 for chemotherapy drug permeation resistance.

Indications for Use

Indicated for use by operating room personnel as a protective barrier against contamination of surgical wounds. Suitable for use during procedures involving chemotherapy drugs, subject to specific permeation resistance limitations.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 26, 2021

Cardinal Health 200, LLC Padmini Sahoo Regulatory Affairs Manager 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K201592

Trade/Device Name: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: August 25, 2021 Received: August 26, 2021

Dear Padmini Sahoo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K201592 Device Name

Cardinal HealthTM ProtexisTM PI Blue with Neu-TheraTM Surgical Gloves

## Indications for Use (Describe)

Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 µg/cm²/min):

| Carmustine | (3.3 mg/mL) 18.5 |
|---------------------------|------------------|
| Cisplatin | (1 mg/mL) >240 |
| Cyclophosphamide | (20 mg/mL) >240 |
| Doxorubicin Hydrochloride | (2 mg/mL) >240 |
| Etoposide | (20 mg/mL) >240 |
| 5-Fluorouracil | (50 mg/mL) >240 |
| Methotrexate | (25 mg/mL) >240 |
| Mitomycin C | (0.5 mg/mL) >240 |
| Paclitaxel | (6 mg/mL) >240 |
| Thiotepa | (10 mg/mL) 24.4 |
| Vincristine Sulfate | (1 mg/mL) >240 |

Please note that the gloves showed extremely low permeation times of 18.5 and 24.4 minutes respectively with Carmustine (BCNU) (3.3 mg/mL) and Thiotepa (10 mg/mL). When chemotherapy drugs are present, gloves selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety for the chemicals being used to determine an adequate level of protection.

| 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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