(35 days)
examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy. This glove is to be used in a Non Sterile environment.
BRIGHTWAY TM Brand Powder Free Latex Examination Gloves Blue Color, Non-Sterile ( containing 50 ugm or less of water extractable protein per gram.) (tested for use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate)
The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving a device meets those criteria, particularly for an AI/algorithm-based medical device.
Therefore, I cannot extract any of the requested information from this document. The document primarily focuses on the regulatory approval for a physical medical device (latex examination gloves) and not on a digital device or algorithm with performance metrics.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2001
Mr. G. Baskaran Manaqing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, MALAYSIA
K011728 Re : Trade/Device Name: Brightway Brand Powder Free Latex Examination Gloves, Blue Non-Sterile, Protein Labeling Claim ( 50 Micrograms or Less ) (Tested for Use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate) Regulation Number: 880.6250 Regulatory Class: I Product Code: LYY Dated: June 1, 2001 Received: June 4, 2001
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 legally marketed predicate 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical
{1}------------------------------------------------
Page 2 - Mr. Baskaran
Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Chrough periodic QD Inbecounting such assumptions. Failure to Administlacion (rBn) #ault in may result in regulatory In addition, FDA may publish further announcements action. action. In an aur device in the Federal Register. Please note: concerning your devrec in the fourification submission does this response to your premaint have under sections 531 not arrood any the Act for devices under the Electronic Chrough 542 OF the nee 10 rovisions, 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 described in your 510\x) promalence of your device to a legally marketed predicate device results in a classification for your marketed predicate acvice 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 regulacion (in e devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreasor as (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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the Bivision of (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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
Enclosure
{2}------------------------------------------------
Indications for use
Applicant 510(k) number Device name
: BRIGHTWAY HOLDINGS SDN. BHD.
:
: BRIGHTWAY TM Brand Powder Free Latex Examination Gloves
Blue Color, Non-Sterile ( containing 50 ugm or less of water extractable protein per gram.) (tested for use with Chemotherapy Drugs, Carmustine, Fluorouracil, Methotrexate)
Indications for use:
BRIGHTWAY™ Brand Powder Free Latex Examination Glove - Blue Color, Non-Sterile
(containing 50 ugm or less of water extractable protein per gram) (tested for use with Chemotherapy Drugs Carmustine, Fluorouracil, Methotrexate)
· examination glove which is worn on the is a disposable hand of healthcare and similar personnel to prevent contamination between patient and examiner and also to protect the examiner's hands from being affected by the chemicals used in therapy.
This glove is to be used in a Non Sterile environment.
Qiu S. Lin
(Division Sign-Off) vision Sign-Off
Ision of Dental, Infection Control, General Hospital Device k) Number .
06/01/01 4 Doc. Ref. : BH/510(k)/ChemLEG
3.0
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.