SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE

K971403 · Sj Medical Products (M) Sdn Bhd · LYY · May 29, 1997 · General Hospital

Device Facts

• Record ID: K971403
• Device Name: SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE
• Applicant: Sj Medical Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

Smart-Glove is a powder-free latex examination glove. It is worn by healthcare professionals during medical examinations to provide a barrier against cross-contamination between the patient and the examiner. The device is disposable and features a protein content labeling claim of 50 micrograms or less of water-extractable protein per gram of glove. It is intended for use in clinical or medical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powder-free latex examination glove. Features protein content labeling claim of 50 micrograms or less of water-extractable protein per gram of glove.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1997

Mr. Foo Knon Pu &J Medical Product SND BHD Lot 723, Batū 5 172, Jālan Kapar, 42100 Klang, Selangor Darul Ehsan MALAYSIA

Re : K971403 SMART - GLOVE® Powder-Free Latex Trade Name: Examination Glove with Protein Content Labeling Claim Requlatory Class: I Product Code: Lyy Dated: April 5, 1997 Received: April 15, 1997

Dear Mr. Foo Knon Pu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಿಗೆ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Foo Knon Pu

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of debtition in your of your device to a legally marketed bubblance device results in a classification for your device and thus, permits your device to proceed to the market. enab, pormal ( regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Mibbianant of Iornation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] for [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Collaitrust

Timotiy Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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MEDICAL PRODUCTS (M) SDN. BHD.

(Company No. 176287 H)

| INDICATIONS FOR USE |
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Indication For Use Statement.

SJ MEDICAL PRODUCTS (M) SDN BHD Applicant :

: K 971403 510K ( Number )

. .

Device Name

3.0

Smart Glove Latex Patternt Examination Gloves Powderfree, 50 mogm or less water extractable protein.

Indication for Use: This glove Is disposable and is intended for medioal purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation ( ODE )

Olin S. hin

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

510(k) Number KG71403

Proscription Use (Per 21 CFR 801.109) OR

Over - The - Counter Use

19ption Porner 1-2-96)

Lot 723, Batu 51/2, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan. Tel: [phone] Fax: [phone]