Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)

K173137 · Hartalega Sdn Bhd · LZA · Dec 12, 2017 · General Hospital

Device Facts

• Record ID: K173137
• Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
• Applicant: Hartalega Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 12, 2017
• 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 Drugs (Pink) 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. Is it also tested to be used against Chemotherapy Drugs.

Device Story

Nitrile powder-free examination glove; worn by healthcare examiners to provide barrier protection against patient-to-examiner contamination. Device tested for permeation resistance against specific chemotherapy drugs (e.g., Carmustine, Cisplatin, Cyclophosphamide, etc.). Used in clinical settings; disposable; non-sterile.

Clinical Evidence

No clinical data; bench testing only. Permeation testing performed for chemotherapy drugs per ASTM standards, reporting breakthrough times for 12 specific agents.

Technological Characteristics

Nitrile material; powder-free; non-sterile; disposable; examination glove form factor.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove to prevent cross-contamination between patient and examiner. Tested for use with 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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December 12, 2017

Hartalega Sdn. Bhd. % Nurul Kong Ouality Assurance Senior Manager Hartalega Sdn. Bhd No.7, Kawasan Perusahaan Suria Bestari Jaya, 45600 My

Re: K173137

Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 21, 2017 Received: September 29, 2017

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. 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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 Glove Tested for Use with Chemotherapy Drugs (Pink)

#### Indications for Use (Describe)

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) 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. Is it also tested to be used against Chemotherapy Drugs.

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

| Carmustine (3.3 mg/ml) | 22.2 minutes |
|---------------------------------------|---------------|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (20 mg/ml) | > 240 minutes |
| Fluorouracil (50 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 37.3 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |

Please note that Carmustine and Thiotepa have extremely low permeation times of 22.2 minutes and 37.3 minutes

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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