BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE

K032940 · Brightway Holdings Sdn. Bhd. · LYY · Nov 20, 2003 · General Hospital

Device Facts

• Record ID: K032940
• Device Name: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Device Story

Device is a sterile, powder-free latex examination glove. Used by healthcare personnel in clinical settings to provide a protective barrier against contamination between patient and examiner. Device functions as a physical barrier; no electronic or algorithmic components. Manufactured to contain 50 µgm or less of water-extractable protein per gram to reduce potential for latex sensitivity.

Clinical Evidence

Bench testing only. Device meets requirements for patient examination gloves under 21 CFR 880.6250, including protein content specifications.

Technological Characteristics

Material: Natural rubber latex. Form factor: Sterile, powder-free examination glove. Protein content: ≤ 50 µgm/g water-extractable protein. Regulatory class: I. Product code: LYY.

Indications for Use

Indicated for use as a patient examination glove to be worn on the hands of healthcare personnel to prevent 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

## JAN 1 2 2004

Mr. G Baskaran Managing Director Brightway Holdings SDN. BHD. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang, Selangor Darul Ehsan MALAYSIA

Re: K032940

Trade/Device Name: "Brightway Brand Latex Examination Gloves (Powder Free, Sterile) Containing 50 µgm or Less of water Extractable Protein Per Gram" Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 15, 2003 Received: September 22, 2003

Dear Mr Baskaran:

This letter corrects our substantially equivalent letter of November 24, 2003 regarding the Trade name.

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 (f(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 (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, Frite 2, , atts 800 00 898. In Register.

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## Mr. Baskaran

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 requires. 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 mor ufacturing proctice 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); all (1) 21 CFR 1000-1050.

This letter will allow you to continue 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 of your device and this, 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the other one of only of of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their the DIVISION of 638-2041 or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Chis

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