BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)

K992021 · Brightsway Holdings Sdn Bhd · KGO · Jul 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992021
• Device Name: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
• Applicant: Brightsway Holdings Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 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 sterile, powder-free natural rubber latex surgical gloves; intended for use by operating room personnel. Primary function is to provide a protective barrier between the clinician's hands and the surgical site to prevent wound contamination. Device is worn during surgical procedures. Benefits include reduction of potential contamination and low protein content (≤ 50 µgm/g) to mitigate latex sensitivity risks.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and compliance with established standards for surgical gloves.

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable surgical glove. Protein content: ≤ 50 µgm/g water extractable protein. Sterile, powder-free.

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

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JUL 23 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K992021 Brightway™ Brand Latex Surgical Gloves -Trade Name: Sterile (Powder Free) Regulatory Class: I Product Code: KGO Dated: June 11, 1999 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 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 (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. पुर 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.

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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: 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.

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 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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone]/for [phone] or at its internet address "http://www.fda.gdv/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

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Applicant 510(k) number Device name

: BRIGHTWAY HOLDINGS SDN. BHD. K992021 : : BRIGHTWAYTM Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.

Indications for use:

BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 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.

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D F. Olk) Number _

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