Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

K220491 · Hainan Asther Medical Equipment Co., Ltd. · LZC · May 14, 2022 · General Hospital

Device Facts

• Record ID: K220491
• Device Name: Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
• Applicant: Hainan Asther Medical Equipment Co., Ltd.
• Product Code: LZC · General Hospital
• Decision Date: May 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) Dacarbazine, 10.0 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil, 50.0 mg/ml (50,000 ppm) Paclitaxel, 6.0 mg/ml (6,000 ppm) Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes WARNING: Do not use with Carmustine and Thiotepa

Device Story

Disposable nitrile examination gloves; worn by healthcare personnel during patient examinations; provides barrier protection. Tested for permeation resistance against specific chemotherapy agents per ASTM D6978-05(2019). Used in clinical settings; protects examiner and patient from cross-contamination. Output is physical barrier protection; informs user of safe handling duration for specific chemotherapy drugs.

Clinical Evidence

Bench testing only. Permeation testing performed per ASTM D6978-05(2019) to determine breakthrough times for specific chemotherapy drugs.

Technological Characteristics

Material: Nitrile. Form factor: Disposable examination glove. Testing standard: ASTM D6978-05(2019) for chemotherapy drug permeation. Non-sterile.

Indications for Use

Indicated for use as a patient examination glove to be worn by examiners to prevent contamination between patient and examiner. Tested for resistance to specific chemotherapy drugs per ASTM D6978-05(2019). Contraindicated for use with 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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May 14, 2022

Hainan Asther Medical Equipment Co., Ltd % Johnson Liu Consultant CNMed Consulting 31 Archer St Upper Mount Gravatt, QLD 4122 Australia

Re: K220491

Trade/Device Name: Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 14, 2022 Received: February 22, 2022

Dear Johnson Liu:

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 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.

Bifeng Qian, M.D., Ph.D. Acting 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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## Indications for Use

510(k) Number (if known)

K220491

Device Name

## Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:

| Cisplatin, 1.0 mg/ml (1,000 ppm) |
|----------------------------------------------------|
| Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) |
| Etoposide, 20.0 mg/ml (20,000 ppm) |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) |

Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes

WARNING: Do not use with Carmustine and Thiotepa

| 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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