GLOVCO EBONY

K013828 · Glovco (M) Sdn. Bhd. · LYY · Aug 13, 2002 · General Hospital

Device Facts

• Record ID: K013828
• Device Name: GLOVCO EBONY
• Applicant: Glovco (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove that is worn by the healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

Black colored, powder-free latex examination gloves; intended for use by healthcare personnel to provide a protective barrier; prevents cross-contamination between patient and clinician; device is a single-use, disposable physical barrier.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Latex; powder-free; black color; protein content labeled at 50 micrograms or less; Class I medical device.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the user and the patient.

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized design of three overlapping human profiles, with three lines above them.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tan Peng Hock Managing Director GLOVCO (M) Sdn. Bhd. Lot 760, Jalan Hahi Sirat, Off Jalan Meru Klang, Selangor D. E., MALAYSIA

Re: K013828

Trade/Device Name: Black Colored Powder-Free Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 10, 2002 Received: July 22, 2002

Dear Mr. Hock:

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 such 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. Hock

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Ciciantefor

Timothy A. Ulatowski 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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#### PREMARKET NOTIFICATION [510(K)] FOR BLACK COLOURED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

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Applicant : GLOVCO (M) SDN BHD

Date : November 7, 2001

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3.0 INDICATION FOR USE

| 510(K) Number (if known) | K013828 |
|--------------------------|---------------------------------------------------------------------------------------------------------|
| Device Name | Black Coloured Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 micrograms or less) |

Indications For Use:

" A patient examination glove that is worn by the healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | OR | Over-The-Counter Use | <div> </div> |
|----------------------|--|----|----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

| 510(k) Number: | K013828 |
|----------------|---------|
|----------------|---------|