Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

K160562 · Hartalega Snd. Bhd. · LZA · Oct 13, 2016 · General Hospital

Device Facts

• Record ID: K160562
• Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
• Applicant: Hartalega Snd. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Nitrile powder-free examination glove; coated with colloidal oatmeal USP. Worn by healthcare professionals during patient examinations to provide a protective barrier against contaminants. Tested for permeation resistance against specific chemotherapy drugs (e.g., Carmustine, Cisplatin, Cyclophosphamide) per ASTM D6978-05. Provides protection for both patient and examiner by preventing cross-contamination. Used in clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided. Testing includes permeation resistance to chemotherapy drugs per ASTM D6978-05.

Technological Characteristics

Nitrile rubber material; powder-free; coated with colloidal oatmeal USP. Non-sterile. Dimensions and physical properties conform to standard examination glove requirements. Permeation resistance tested per ASTM D6978-05.

Indications for Use

Indicated for use as a patient examination glove to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs as tested per ASTM D6978-05.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

October 13, 2016

Hartalega Sdn. Bhd. Mr. H. Carl Jenkins Regulatory Counsel to Hartalega Sdn. Bhd. 10 E. Scranton Ave. Suite 201 Lake Bluff, IL 60044

Re: K160562

Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP 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: September 7, 2016 Received: September 9, 2016

Dear Mr. Jenkins:

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

{1}------------------------------------------------

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 yours.

# 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K160562

#### Device Name

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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

| Carmustine (3.3 mg/ml) | 10.1 minutes |
|---------------------------------------|--------------|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.1 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Etoposide (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 (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |

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 PRAStaff(@fda.hhs.gov

"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."