Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs

K150103 · Hartalega Sdn Bhd · LZA · Apr 23, 2015 · General Hospital

Device Facts

• Record ID: K150103
• Device Name: Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.

Device Story

Nitrile powder-free examination gloves; non-sterile; disposable. Designed as protective barrier for medical/dental personnel to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs; provides breakthrough time data for 14 agents. Used in clinical/dental settings; worn by healthcare providers. Protects examiner and patient from exposure to biological contaminants and chemotherapy agents.

Clinical Evidence

Bench testing only. Permeation testing performed for 14 chemotherapy drugs per ASTM standards. Breakthrough times reported; Carmustine (45.4 min) and Thiotepa (30.9 min) identified as having lower permeation resistance compared to other tested agents (>240 min).

Technological Characteristics

Material: Nitrile rubber. Form factor: Powder-free examination glove. Non-sterile. Single-use. Tested for chemotherapy drug resistance.

Indications for Use

Indicated for use by medical and dental professionals as a protective barrier on the examiner's hands to prevent contamination between patient and examiner. Suitable 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

April 23, 2015

Hartalega Sdn. Bhd. Ms. Nurul Aisyah Kong Binti Abdullah Quality Assurance Senior Manager No. 7 Kawasan Perusahaan Suria Bestari Jaya Selangor Darul Ehsan 45600 MALAYSIA

Re: K150103

Trade/Device Name: Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 18, 2015 Received: March 23, 2015

Dear Ms. Abdullah:

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.

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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 (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K150103

### Device Name

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

#### Indications for Use (Describe)

The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 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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Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs.

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| Chemotherapy Drugs | Minimum Breakthrough Time<br>(Minutes) |
|-----------------------------------------------------|----------------------------------------|
| Carmustine (BCNU)<br>3.3 mg/ml (3,300 ppm) | 45.4 |
| Cisplatin<br>1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan)<br>20 mg/ml (20,000 ppm) | > 240 |
| Dacarbazine (DTIC)<br>10.0 mg/ml ( 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride<br>2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide (Toposar)<br>20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil<br>50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide<br>50.0 mg/ml (50,000 ppm) | > 240 |
| Methotrexate<br>25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C<br>0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone<br>2.0 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel (Taxol)<br>6.0 mg/ml (6,000 ppm) | > 240 |
| Thiotepa<br>10.0 mg/ml (10,000 ppm) | 30.9 |
| Vincristine Sulfate<br>1.0 mg/ml (1,000 ppm) | > 240 |

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