SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR

K033683 · Smart Glove Corp. Sdn Bhd · LZA · Jan 8, 2004 · General Hospital

Device Facts

• Record ID: K033683
• Device Name: SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
• Applicant: Smart Glove Corp. Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jan 8, 2004
• 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

Smart-Feel Powder Free Nitrile Examination Gloves (Pink Color) are disposable, non-sterile patient examination gloves. Worn by healthcare professionals on the hands during medical examinations to provide a protective barrier, the gloves prevent cross-contamination between the examiner and the patient. The device is used in clinical or medical settings. It functions as a physical barrier; no electronic, software, or algorithmic components are involved.

Clinical Evidence

bench testing only

Technological Characteristics

Nitrile examination glove; powder-free; pink color; disposable; non-sterile. Material properties consistent with standard nitrile examination gloves under 21 CFR 880.6250.

Indications for Use

Indicated for use as a disposable patient examination glove worn by healthcare examiners to prevent cross-contamination between the patient and the 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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2004

Mr. Foo Khon Pu Managing Director Smart Glove Corporation SDN.BHD. Lot 6487, Batu 534, Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan MALAYSIA

Re: K033683

Trade/Device Name: Smart-Glove Powder Free Nitrile Examination Gloves Pink Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 7, 2003 Received: November 24, 2003

Dear Mr. Pu:

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 approvisions 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 (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it has 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. Pu

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 modified in the Federal statutes and regulations administered by other Federal agencies. or the Free of any - each all the Act's requirements, including, but not limited to: registration 1 od intilisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and inomis (s 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rins reter notification. The FDA finding of substantial equivalence of your device to a promarket notification in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you deems specific as a Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrls/dsma/dsmamain.html

Sincercly yours,

Clis

Chiu Lin, Ph.D. 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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CORPORATION SDN. BHD

Company No. 403570-D

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Indication for Use Statement: 3.0

## INDICATION FOR USE

| Applicant: | SMART GLOVE CORPORATION SDN. BHD. |
|----------------------------|----------------------------------------------------------------|
| 510(k) Number: Applied for | K033683 |
| Device Name: | SMART-FEEL Powder Free Nitrile Examination Gloves (Pink Color) |

## 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.

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

Prescription Use Per 21 CFR 801.109

Over-The-Counter ਾਕ

Over-The-Counter
(Optional Format 1-2-96)

Jilruen Dr. Halers, Senile Chef

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

510(k) Numbe

Image /page/2/Picture/16 description: The image shows three different certification logos. The first logo is a diamond shape with the words "QUALITY SYSTEM" inside. The second logo is a square shape with a crown and a checkmark, and the letters "UKAS" below. The third logo is a trapezoid shape with the letters "TUV" inside.