BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

• K Number: K990542
• Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
• Manufacturer: BRIGHTWAY HOLDINGS SDN. BHD.
• Date Cleared: 1999-04-09 ( 46 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Brightway™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Device Description

Brightway™ Brand Nitrile Examination Glove (Powdered)

AI/ML Overview

I am sorry, but based on the provided document, the information required to answer your request is not present. The document is a 510(k) clearance letter for "Brightway™ Brand Nitrile Examination Glove (Powdered)" and contains regulatory information about the device's classification and marketing authorization. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation.

Summary

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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 a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 19 1999

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

K990542 Re : Brightway™ Brand Nitrile Examination Trade Name: Glove (Powdered) Requlatory Class: I Product Code: LZA February 16, 1999 Dated: Received: February 22, 1999

Dear Mr. Baskaran:

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, Druq, and Cosmetic Act (Act). 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Baskaran

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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

Enclosure

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REVISED LABELING : 22" MARCH 1999 510 (K) NO. : K. 990542 910 (R) NO. AN INATION GLOVES (POWDERED)

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3.0 Indications for use

Applicant	: BRIGHTWAY HOLDINGS SDN. BHD.
510(k) number	: K990542
Device name	: Brightway™ Brand Nitrile Examination Gloves (Powdered)

Indications for use:

Brightway™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of General Infection Control,
	and General Hospital Devices
510(k) Number	990542

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use X
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(Optional Format 1-2-96)

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.