(33 days)
BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is intended to be worn by a ulsposable glove made or by a protect a surgical wound from contamination.
BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered)
This looks like a 510(k) clearance letter for Nitrile Surgical Gloves. The provided text does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment relevant to the request. This document is a regulatory approval letter, not a study report.
Therefore, I cannot answer the questions based on the provided input.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human figures, representing the department's focus on health and human well-being. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 12 1999
Mr. G. Baskaran Managinq Director Brightway Holding Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K991940 Brightway™ Brand Nitrile Surgical Gloves -Trade Name: Sterile (Powdered) Requlatory Class: I 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Baskaran
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 findinq 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runar
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{2}------------------------------------------------
3.0 Indications for use
: BRIGHTWAY HOLDINGS SDN. BHD. Applicant K991940 .. 510(k) number : BRIGHTWAY™ Brand Nitrile Surgical Device name Gloves - Sterile (Powdered)
Indications for use:
BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is BRIGHT WAT -- Drand Nitrie Barger intended to be worn by a ulsposable glove made or by a 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 (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospital I 510(k) Number
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).