GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)

K021730 · Glovco (M) Sdn. Bhd. · LZA · Jul 5, 2002 · General Hospital

Device Facts

• Record ID: K021730
• Device Name: GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
• Applicant: Glovco (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Powder-free nitrile examination glove; serves as protective barrier; worn by healthcare or similar personnel; prevents cross-contamination between user and patient; used in clinical or similar settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powder-free; examination glove form factor; Class I medical device.

Indications for Use

Indicated for use by healthcare or 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the department's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 5 2002 ்பட

Mr. Tan Peng Hock Executive Director Glovco (M) Sdn. Bhd. Lot 760, Jalan Haji Sirat, Off Jalan Meru Klang. Selangor D.E., MALAYSIA 42100

Re: K021730

Trade/Device Name: Powder-Free Nitrile Examination Glove, (Purple) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 21, 2002 Received: May 24, 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.

{1}------------------------------------------------

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 CTR Part 820). and 11 applicable, the electronic product radiation control provisions 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Quanv

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

{2}------------------------------------------------

GLOVCO (M) SDN BHD Applicant ・・ May 18, 2002 Date '

page 5 of 10

## INDICATION FOR USE 3.0

510(K) Number (if known)

K02173\$\varnothing\$

Device Name

: Powder-Free Nitrile Examination Glove ( RURALE)

Indications For Use:

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

Chin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)