NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs

K152222 · Gmp Medicare Sdn Bhd (F25) · LZC · Apr 21, 2016 · General Hospital

Device Facts

• Record ID: K152222
• Device Name: NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
• Applicant: Gmp Medicare Sdn Bhd (F25)
• Product Code: LZC · General Hospital
• Decision Date: Apr 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Nitrile Blue Powder Free Examination Gloves are disposable, non-sterile medical gloves. Designed for use by healthcare professionals during patient examinations to provide a barrier against contamination. The device is manufactured from nitrile material. Key feature is the tested resistance to permeation by various chemotherapy drugs, evaluated per ASTM D6978-05. The gloves provide a protective barrier for the wearer's hands; they do not involve electronic components, software, or algorithms. Used in clinical settings to protect both patient and examiner from cross-contamination.

Clinical Evidence

No clinical data. Bench testing only. Permeation testing performed per ASTM D6978-05 for 13 chemotherapy drugs, with breakthrough detection times reported for each.

Technological Characteristics

Nitrile material; disposable; powder-free; non-sterile. Tested for chemotherapy drug permeation per ASTM D6978-05. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

April 21, 2016

GMP Medicare SDN. BHD. Ms. Eva Mustafa QA Manager Lot/PT64593. Jalan Dahlia/KU8 Kawasan Perindustrian Meru Timur 41050 Klang, Selangor D.E. MALAYSIA

Re: K15222

Trade/Device Name: Nitrile Blue Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: March 28, 2016 Received: April 15, 2016

Dear Ms. Mustafa:

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

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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 devicerelated adverse events) (21 CFR 803); good 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.

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 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) K152222

#### Device Name

Nitrile Blue Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs

### Indications for Use (Describe)

Indication Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

- The following chemicals have been tested with these gloves

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|---------------|----------------------------------------|
| Carmustine (BCNU) | 3.3mg/ml | *10.1 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 |
| Fluorouracil | 50.0mg/ml | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 |
| Thiotepa | 10.0mg/ml | *20.2 |
| Amethopterin Hydrate | 25.0mg/ml | >240 |
| Methotrexate | 25.0mg/ml | >240 |
| Mitomycin C | 0.5mg/ml | >240 |
| Vincristine Sulfate | 1.0mg/ml | >240 |

* Please note that the following drugs have extremely low permeation times:

Carmustine (BCNU): 10.1 minutes and Thiotepa: 20.2 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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