NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

K162858 · Careplus (M) Sdn Bhd · LZC · Jul 24, 2017 · General Hospital

Device Facts

• Record ID: K162858
• Device Name: NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
• Applicant: Careplus (M) Sdn Bhd
• Product Code: LZC · General Hospital
• Decision Date: Jul 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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. 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

Nitrilecare Nitrile Examination Gloves are disposable, powder-free, blue nitrile gloves. Designed for use by healthcare professionals in clinical settings to provide a protective barrier against contamination between the examiner and the patient. The device is also tested for resistance to permeation by specific chemotherapy drugs per ASTM D6978-05. The gloves are intended for both prescription and over-the-counter use.

Clinical Evidence

Bench testing only. The device was evaluated for chemotherapy drug permeation according to ASTM D6978-05. Breakthrough detection times were measured for 12 chemotherapy agents, with results ranging from 10.2 minutes (Carmustine) to >240 minutes for most other tested agents.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free, blue, disposable examination glove. Testing standard: ASTM D6978-05 for chemotherapy drug permeation. No electronic or software components.

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare personnel to prevent 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2017

Careplus (M) Sdn. Bhd. Lim Shyan CEO/ Managing Director Lot 120 & 121, Jalan Senawang 3 Senawang Industrial Estate 70450 Seremban, Malaysia

Re: K162858

Trade/Device Name: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: October 12, 2016 Received: June 26, 2017

Dear Lim Shyan:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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,

Mark S. Fellman -S

for

Lori Wiggins, MPT, CLT 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) K162858

Device Name

Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest

## Indications for Use (Describe)

A 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.

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 Drugs Permeation

The following chemicals have been tested with these gloves.

| Chemotherapy | Concentration | Minimum Breakthrough Detection Time (min) |
|---------------------------------------|---------------|-------------------------------------------|
| Fluorouracil (Adrucil) | 50.0mg/ml | >240 |
| Etopside(Toposar) | 20.0mg/ml | >240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | >240 |
| *Carmustine(BCNU) | 3.3mg/ml | 10.2 |
| *Thiotepa | 10.0mg/ml | 40.5 |
| Paclitaxel(Taxol) | 6.0mg/ml | >240 |
| Doxorubicin Hydrochloride(Adriamycin) | 2.0mg/ml | >240 |
| Dacarbazine | 10.0mg/ml | >240 |
| Cisplatin | 1.0mg/ml | >240 |
| Ifosfamide | 50.0mg/ml | >240 |
| Mitoxantrone | 2.0mg/ml | >240 |
| Vincristine Sulfate | 1.0mg/ml | >240 |

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

Carmustine (BCNU) :10.2 minutes and Thiotepa:40.5 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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.