Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs

K182308 · Sri Trang Gloves (Thailand) Co., Ltd. · LZA · May 30, 2019 · General Hospital

Device Facts

• Record ID: K182308
• Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
• Applicant: Sri Trang Gloves (Thailand) Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 30, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Device Story

Disposable nitrile examination glove; worn by healthcare personnel to provide barrier protection against contamination between patient and examiner. Device is non-sterile and powder-free. Tested for permeation resistance against specific chemotherapy drugs (e.g., Carmustine, Cisplatin, Cyclophosphamide, etc.) per ASTM D6978-05. Used in clinical settings; provides protection during handling of chemotherapy agents. Benefit includes reduced risk of cross-contamination and chemical exposure to the wearer.

Clinical Evidence

No clinical data. Bench testing only, specifically permeation testing per ASTM D6978-05 for chemotherapy drug resistance.

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, pink examination glove. Testing standard: ASTM D6978-05 for chemotherapy drug permeation. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent patient-examiner contamination. Suitable for use with specific chemotherapy drugs as tested per ASTM D6978-05.

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, 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.

May 30. 2019

Sri Trang Gloves (Thailand) Co., LTD. % M. Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA DBA Ventyv 5401 West Kennedy Boulevard. Suite 760 Tampa, Florida 33609-2447

Re: K182308

Trade/Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 3, 2018 Received: August 24, 2018

Dear Mr. Smith:

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.

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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 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 David Krause, PhD Acting Division 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) K182308

Device Name

Non-sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The tested chemotherapy drugs are as follows:

Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes Methotrexate 25 mg/mL, No breakthrough up to 240 minutes Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes

CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.

| 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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