Cardinal Health Nitrile Exam Gloves

K241780 · Cardinal Health200, LLC · LZA · Aug 23, 2024 · General Hospital

Device Facts

• Record ID: K241780
• Device Name: Cardinal Health Nitrile Exam Gloves
• Applicant: Cardinal Health200, LLC
• Product Code: LZA · General Hospital
• Decision Date: Aug 23, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable nitrile patient examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978. Not for use with Carmustine or Thiotepa due to low breakthrough times. Used in clinical settings; intended for over-the-counter use.

Clinical Evidence

Bench testing only. Testing performed per ASTM D6978 to assess resistance to permeation by chemotherapy drugs. Breakthrough detection times provided for 15 specific chemotherapy agents.

Technological Characteristics

Nitrile material; non-powdered; disposable. Complies with ASTM D6978 for chemotherapy drug permeation resistance.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, excluding Carmustine and Thiotepa.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2024

Cardinal Health 200, LLC Vani Bala Senior Specialist, Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K241780

Trade/Device Name: Cardinal Health Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: July 15, 2024 Received: July 29, 2024

Dear Vani Bala:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices

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Enclosure

Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K241780

#### Device Name Cardinal Health Nitrile Exam Gloves

### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 30.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 50.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that the following drugs have extremely low permeation times of less than 60 minutes: Carmustine (BCNU) (3.3mg/ml): 30.1 minutes Thiotepa (10.0 mg/ml): 50.5 minutes.

Warning: Do not use with Carmustine or Thiotepa.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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