POWDERFREE BLACK NITRILE EXAMINATION GLOVES

K102620 · Pt. Medisafe Technologies · LZA · Nov 22, 2010 · General Hospital

Device Facts

• Record ID: K102620
• Device Name: POWDERFREE BLACK NITRILE EXAMINATION GLOVES
• Applicant: Pt. Medisafe Technologies
• Product Code: LZA · General Hospital
• Decision Date: Nov 22, 2010
• 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.

Device Story

Powder-free black nitrile examination glove; disposable; worn by healthcare examiners; prevents cross-contamination between patient and examiner; used in clinical settings; provides barrier protection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile material; powder-free; patient examination glove; Class I device; 21 CFR 880.6250.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Anil Taneja Chief Executive Official PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia 20362

Re: K102620

Trade/Device Name: Powder Free Black Nitrile Examination Gloves Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 26, 2010 Received: October 29, 2010

Dear Mr. Taneja:

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.

NOV 2 2 2010

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Page 2- Mr. Taneja

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Joma2000

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K102620

## NOV 2 2 2010

## INDICATION FOR USE

| Applicant | : Medisafe Technologies |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | : K102620 |
| Device Name | :Powder Free Black Nitrile Examination Gloves |
| Indications For Use | : A patient examination glove is a disposable device intended for medical<br>purposes that is worn on the examiner's hand or finger to prevent<br>contamination between patient and examiner. |

Prescription Use ***_***_ Or Over-The-Counter √***_***_
Per 21 CFR 801.109

Elizabeth P. Loverie-Williams

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology. General Hospital
Division of Anesthesiology. General Devices Division of Antool, Dental Devices

510(k) Number: K102620