POWDER FREE NITRILE EXAMINATION GLOVES, BLACK

K092034 · Pt. Smartglove Indonesia · LZA · Oct 19, 2009 · General Hospital

Device Facts

• Record ID: K092034
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
• Applicant: Pt. Smartglove Indonesia
• Product Code: LZA · General Hospital
• Decision Date: Oct 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove 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

Powder-free nitrile examination gloves; disposable; worn on examiner's hands. Function: barrier protection to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals or for general examination purposes. Output: physical barrier. Benefit: infection control.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Nitrile rubber. Form factor: Powder-free examination glove. Color: Black. Sterilization: Non-sterile. Regulatory class: I. Product code: LZA.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners 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.

Predicate Devices

• Powder Free Nitrile Examination Gloves (K042034)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a circular seal with an eagle in the center. The eagle is facing left with its wings spread. The text around the eagle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Mr. Soon Tuck Kwan PT. Smart Glove Indonesia JL Pelita Raya No 5-7, Kawasan Industri Medan Star. JE Raya Medan-Lubuk Pakam Km 19, Tanjung Morawa B, Tanjung Morawa, Deli Serdang, Kode Pos 20362, Sumatera Utara, INDONESIA

## OCT 1 7 2009

Re: K092034

Trade/Device Name: Powder Free Nitrile Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 5, 2009 Received: October 8, 2009

Dear Mr. Kwan:

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. Kwan

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.html 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.

Antman D. nstein br

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):

Device Name: Powder Free Nitrile Examination Gloves, Black

Indication For Use:

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

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Shalie W. Murphrey, KO

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

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510(k) Number: K042034