BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)

K992020 · Brightsway Holdings Sdn Bhd · KGO · Jul 26, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992020
• Device Name: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
• Applicant: Brightsway Holdings Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable natural rubber latex surgical glove; sterile and powdered; intended for use by operating room personnel. Primary function is to provide a protective barrier between the clinician and the surgical site to prevent wound contamination. Device is worn on the hands during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable surgical glove. Sterilization: Sterile. Feature: Contains 150 µgm or less of water extractable protein per gram.

Indications for Use

Indicated for use by operating room personnel as a disposable natural rubber glove to protect surgical wounds from contamination.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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

JUL 26 1999

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

Re : K992020 Brightway™ Brand Latex Surgical Gloves -Trade Name: Sterile (Powdered) Regulatory Class: I KGO Product Code: June 11, 1999 Dated: Received: June 16, 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 requlation may result in regulatory action.

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Page 2 - Mr. Baskaran

In addition, FDA may publish further announcements concerning your device in the Federal Register.

this response to your premarket notification Please note: Flease note: enro-affect any obligation you might have under submission accb noe arroom.
Sections 531 through 542 of the Act for devices under the Sections 351 children Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis lecter will arrow your was and the motification. The FDA described in your sie in promalence of your device to a legally Finding of subbeaneral oquiresults in a classification for your marketed predicate actre your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoort 801 and additionally 809.10 for in regulation (21 of the s), please contact the Office of Itilo draghobere at [phone]. Additionally, for questions on Compriance at (50) deertising 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 Information on your of Small Manufacturers Assistance obcained from the Drvibion or 6.ma-2041 or [phone] or at at its corr free namber (o://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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## 3.0 Indications for use

| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---------------|---------------------------------------------------------------------------------------------------|
| 510(k) number | : K992020 |
| Device name | : BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered) Containing 150 ugm or less of water |

Indications for use:

BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Extractable protein per gram.

Chiu S. Lin

(Division S