Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)

K143247 · Central Medicare Sdn Bhd · LZA · Jan 22, 2015 · General Hospital

Device Facts

• Record ID: K143247
• Device Name: Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
• Applicant: Central Medicare Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jan 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; non-sterile; available in blue, black, and white. Worn by healthcare professionals or examiners to provide a protective barrier; prevents cross-contamination between patient and examiner during medical procedures. Device is a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powder-free; non-sterile; disposable; patient examination glove; Class I; Product Code LZA.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 20, 2015

Central Medicare Sdn. Bhd.
% Mr. Dave Yungvirt
Third Party Review Group, LLC
45 Rockefeller Plaza
Suite 2000
New York, New York 10111

Re: K143247
Trade/Device Name: Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, Black Colored, and White Colored)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient examination glove
Regulatory Class: I
Product Code: LZA
Dated: January 5, 2015
Received: January 8, 2015

Dear Mr. Yungvirt:

This letter corrects our substantially equivalent letter of January 22nd, 2015.

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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Page 2 – Dave Yungvirt

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/ResourcesforYou/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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
**Indications for Use** | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known)
K143247 | |
| Device Name
Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) | |
| Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | |
| Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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
[e-mail]

“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.” | |

FORM FDA 3881 (8/14)
Page 1 of 1
FSC Publishing Services [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 22, 2015

Central Medicare Sdn. Bhd.
% Mr. Dave Yungvirt
CEO
Third Party Review Group, LLC
45 Rockefeller Plaza
Suite 2000
New York, NY 10111

Re: K143247
Trade/Device Name: Powder Free Nitrile Examination Gloves, Non Sterile, (Blue Colored, Black Colored, and White Colored)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient examination glove
Regulatory Class: I
Product Code: LZA
Dated: January 5, 2015
Received: January 8, 2015

Dear Mr. Yungvirt,

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.