SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803

K093696 · Central Medicare Sdn Bhd · LZA · Feb 12, 2010 · General Hospital

Device Facts

• Record ID: K093696
• Device Name: SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
• Applicant: Central Medicare Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Blue Nitrile Examination Gloves, Powder Free, are disposable protective barriers worn by healthcare examiners. The gloves function as a physical barrier to prevent cross-contamination between the patient and the examiner during medical procedures. They are intended for use in clinical or medical settings. The device is a passive, non-sterile or sterile (as applicable) physical barrier; it does not involve electronic processing, algorithms, or software. The benefit to the patient and examiner is the reduction of potential pathogen transmission during physical examinations.

Clinical Evidence

Bench testing only.

Technological Characteristics

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

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. Suitable for over-the-counter use.

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/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## FEB 1 2 2010

Central Medicare Sdn. Bhd. C/O Mr. Nick Wang Senior Vice President Encompass Medical Supplies, Incorporated 1930 South Brea Canyon Road, # 240 Diamond Bar, California 91765

Re: K093696

Trade/Device Name: Blue Nitrile Examination Gloves, Powder Free Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 20, 2009 Received: November 30, 2009

Dear Mr. Wang:

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.

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- Mr. Wang

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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K093696

Image /page/2/Picture/1 description: The image contains a logo for Central Medicare. The words "Central Medicare" are written in a bold, sans-serif font. Below the word "Medicare" is the text "CENTRAL MEDICARE SDN BHD" in a smaller font. To the left of the text is a graphic of a globe.

CENTRAL MEDICARE SDN. BHD. (660896 T)

(FORMERLY KNOWN AS CENTRAL BOILER AND ENERGY SYSTEM SDN. BHD.) PT 2609 - 2620, Bt 8,Jalan Changkat Jong, Mukim Changkat Jong, Teluk Intan, Perak. Tel: [phone] Fax: [phone]

## INDICATION FOR USE

| Applicant: | Central Medicare Sdn Bhd |
|----------------|----------------------------------------------|
| 510(k) Number: | K093696 |
| Device Name: | Blue Nitrile Examination Gloves, Powder Free |

Indication for Use:

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use __

AND/OR

Over-The-Counter Use_ X

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Elizabeth F. Clumio-Wills

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO93696 510(k) Number: