Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)

K200019 · Hartalega NGC Sdn. Bhd. · LZA · Apr 6, 2020 · General Hospital

Device Facts

• Record ID: K200019
• Device Name: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
• Applicant: Hartalega NGC Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

Device Story

Nitrile powder-free examination gloves; nonsterile; disposable. Worn by clinicians/examiners to provide barrier protection against cross-contamination between patient and examiner. Tested for permeation resistance against various chemotherapy agents and fentanyl citrate per ASTM D6978-05. Used in clinical settings. Provides barrier protection; reduces risk of exposure to hazardous drugs during handling/administration.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs, measuring breakthrough detection times for various chemotherapy agents and fentanyl citrate.

Technological Characteristics

Nitrile material; powder-free; nonsterile; disposable. Form factor: examination glove. Tested per ASTM D6978-05 (Reapproved 2013) for permeation resistance to chemotherapy drugs and fentanyl citrate. No software or electronic components.

Indications for Use

Indicated for use as a nonsterile, disposable patient examination glove worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and fentanyl citrate 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2020

Hartalega NGC Sdn. Bhd. Nurul Kong Senior Manager - Quality Assurance Kawasan Perindustrian Tanjung Sepang, 43900 My

Re: K200019

Trade/Device Name: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: January 10, 2019 Received: January 15, 2020

Dear Nurul Kong:

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 (OS) 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.

CAPT Elizabeth Claverie, M.S. 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) K200019

#### Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue)

#### Indications for Use (Describe)

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate,

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs,

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 23.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 58.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Azacytidine (25.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan (20 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oncovin (1.0 mg/ml) | >240 |
| Oxaliplatin (5 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 23.3 minutes and 58.2 minutes respectively.

| Fentanyl Citrate and Concentration<br>Fentanyl Citrate Injection (100 mcg/2ml) | Minimum Breakthrough Detection Time in Minutes<br>>240 |
|--------------------------------------------------------------------------------|--------------------------------------------------------|
|--------------------------------------------------------------------------------|--------------------------------------------------------|

Type of Use (*Select one or both, as applicable*)

| Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------|
| <b>X</b> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

#### 510(k) Number (if known) K200019

#### Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentany) Citrate (Black)

### Indications for Use (Describe)

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3,3 mg/ml) | 25.0 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 55.7 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Azacytidine (25.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan (20 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oncovin (1.0 mg/ml) | >240 |
| Oxaliplatin (5 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 25.0 minutes and 55.7 minutes respectively.

Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240

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)

FORM FDA 3881 (7/17)

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### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number:"