BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)

K990878 · Brightway Holdings Sdn. Bhd. · LZA · May 21, 1999 · General Hospital

Device Facts

• Record ID: K990878
• Device Name: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: May 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable nitrile examination glove; worn on hand by healthcare personnel; barrier protection to prevent cross-contamination between patient and examiner; non-sterile; powder-free.

Clinical Evidence

No clinical data provided; device relies on bench testing and compliance with general controls for examination gloves.

Technological Characteristics

Material: Nitrile rubber; form factor: disposable examination glove; powder-free; non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable patient examination glove to prevent cross-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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1999

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

K990878 Re : Brightway™ Brand Blue Nitrile Examination Trade Name: Gloves Powder-Free Regulatory Class: I Product Code: LZA Dated: May 3, 1999 Received: May 6, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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) regulation (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 requlation 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 labelinq regulation (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, - Yaza Jusuviv.

t

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## 3.0 Indications for use

Applicant 510(k) number Device name

: BRIGHTWAY HOLDINGS SDN. BHD. : K 990978
: Brightway™ Brand Colored Nitrile Examination Gloves (Powder Free)

Indications for use:

BLUE

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

Olin S. Lahn

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of Dospital Devices 510(k) Number

Over-the-Counter Use

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