Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

K162924 · Hartalega Sdb. Bhd. · LZA · Jan 24, 2017 · General Hospital

Device Facts

• Record ID: K162924
• Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
• Applicant: Hartalega Sdb. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is a non - sterile 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. The list of Chemotheray Drugs (tered with breakthrough times) is as per below table. The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Violet Blue (DVBU) is a non - sterile 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. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table. The Nitile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU) is a non sterile 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. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.

Device Story

Nitrile powder-free examination gloves; non-sterile; disposable. Worn by clinicians to provide barrier protection against patient-to-examiner contamination. Tested for permeation resistance against specific chemotherapy drugs (e.g., Carmustine, Cisplatin, Cyclophosphamide, etc.). Breakthrough times vary by drug and glove color variant (White, Dark Violet Blue, Dark Blue). Used in clinical settings; provides protection during handling of hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. Permeation testing performed for various chemotherapy drugs per ASTM standards. Breakthrough times reported for each drug variant.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile; disposable; ambidextrous; various colors (White, Dark Violet Blue, Dark Blue).

Indications for Use

Indicated for use by medical examiners as a non-sterile, disposable barrier to prevent cross-contamination between patient and examiner; also indicated for use during handling of specific chemotherapy drugs.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2017

Hartalega Sdb. Bhd. Nurual Kong Quality Assurance Senior Manager No.7, Kawasan Perusahaan Suria Bestari Jaya, 45600 MY

Re: K162924

Trade/Device Name: Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated December 14, 2016 Received: December 19, 2016

Dear Nurual 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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

:

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)

#### Indications for Use (Describe)

The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is a non - sterile 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. The list of Chemotheray Drugs (tered with breakthrough times) is as per below table.

The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:

| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---------------------------------------|---------------|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 15.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |

* Please note that the following drugs have extremely low permeation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 15.4 minutes with Thiotepa (10.0 mg/ml).

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)

#### 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 annound the and review the collection of information. Send comments regarding this burden estimate or any other onpect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

De not Nemo

## Indications for Use (Describe)

The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Violet Blue (DVBU) is a non - sterile 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. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.

The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:

| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---------------------------------------|---------------|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 46.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |

* Please note that the following drugs have extremely low perneation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 46.4 minutes with Thiotepa (10.0 mg/ml).

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)

#### 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."

FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

{4}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

#### Device Name

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU)

### Indications for Use (Describe)

The Nitile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU) is a non sterile 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. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.

The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:

| Carmustine (BCNU) (3.3 mg/ml) | 1.7 minutes |
|---------------------------------------|---------------|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 10.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |

* Please note that the following drugs have extremely low permeation times of 1.7 minutes with Carmustine (3.3 mg/ml) and 10.8 minutes with Thiotepa (10.0 mg/ml).

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)

#### 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 spect 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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF