BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)

K991939 · Brightway Holdings Sdn. Bhd. · KGO · Jul 1, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991939
• Device Name: BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

BRIGHTWAY™ Brand Nitrile Surgical Glove - Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worry by operating room personnel to protect a surgical wound from contamination.

Device Story

BRIGHTWAY™ Brand Nitrile Surgical Glove is a sterile, powder-free, disposable synthetic rubber glove. Used by operating room personnel during surgical procedures. Primary function is to serve as a protective barrier to prevent contamination of surgical wounds. Device is a physical barrier; no electronic, software, or algorithmic components involved. Used in clinical/surgical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Synthetic rubber (nitrile). Form factor: Sterile, powder-free surgical glove. Sterilization: Not specified. No electronic, software, or energy-based components.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Disposable, sterile, powder-free synthetic rubber glove.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Mr. G. Baskaran Managing Director Managing Holdings Sdn. Bhd. Brightway nordings Batu Belah Lot 1539, Galangor Darul Ehsan MALAYSIA

BRIGHTWAY® Brand Nitrile Surgical Gloves каатаза Re : Trade Name: Sterile (Powder-Free) Regulatory Class: Product Code: KGO Dated: May 28, 1999 Received: June 9, 1999

## Dear Mr. Baskaran:

We have reviewed your Section 510 (k) notification of intent to
the states by increased above and we have determined the we have reviewed your Section 510(K) noctr.roused market the device referenced above and wo works.
device is substantially equivalent (for the indications for device is substantially equivalenc (for marketed in interstate
use stated in the enclosure) to devices marketed in interstate use stated in the enclosure) to devices mant one of the commerce prior to May 28, 1976, the cheen that have been
Medical Device Amendments, or to devices that have been Medical Device Amendents, of Co devices biso incoment
reclassified in accordance with the provisions of the Federal reclassified in accordance with the provisay, therefore, Food, Drug, and Cosmetic Act (Acc). Too may ,
market the device, subject to the general controls provisions of the Act market the device, subject to the general os of the Act
of the Act. The general controls provisions of the Act
of the Act. The general controls registration, listing o of the Act. The general controls provision listing of
include requirements for annual registice, labeling, and include requirements for annual rose, labeling, and devices, good manufacturing pracesses,
prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II
n the see and becamelars TIT (Premarket Approval), it may If your device is class III (Premarket Approval), it may
(Special Controls) or class III (Premarket Approval), it may (Special Controls) or class lir (romerols. Existing major be subject to such addicional concrease tound in the Code of .
regulations affecting your device can be tound in the Code of ... A regulations arrecting your as , Parts 800 to 895 .
Federal Regulations, Title 21, Parts 800 to a rederal Regulations , Title Zi, Parcs 800 co operation with substantially equivalent deteimination devices: General
the Good Manufacturing Practice for Medical Through periodic the Good Manufacturing Practice Tourbat - through periodic
(GMP) regulation (21 CFR Part 820) and that, through periodic (GMP) regulation (2) CFR Farl over and Drug Administration (FDA) will
GMP inspections, the Food Esilyro to comply with the GMP GMP inspections, the FOOD and Dray names.
verify such assumptions. Failure to comply with addition verify such assumptions - Farrare co compar - In addition, FDA
regulation may result in regulatory action, your device in regulation may result in regulatory actions
may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Baskaran

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 requlations.

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 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".

Sincerety yours,

Susan Kumpa
(_Timothy A. Ulatowski

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

ರ್ಕರ

Enclosure

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3.0 Indications for use

| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---------------|----------------------------------------------------------------------|
| 510(k) number | : K991939 |
| Device name | : BRIGHTWAY™ Brand Nitrile Surgical<br>Glove - Sterile (Powder-Free) |

Indications for use:

BRIGHTWAY™ Brand Nitrile Surgical Glove - Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worry by operating room personnel to protect a surgical wound from contamination.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pct 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Olin S. lin

(Division Sign-Off Division of Dental, Info and General Hospit 510(k) Number

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