(30 days)
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 ugm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of the examiner to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Blue Color Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram.
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information. This document pertains to a medical device (latex examination gloves) and not an AI-powered device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah, 42100 Klang Selangor Darul Ehsan MALAYSIA
Re : K991750 Brightway™ Brand Blue Color Latex Trade Name: Examination Gloves, Powder Free Containing 50 µgm or Less of Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY Dated: May 20, 1999 Received: May 24, 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 (Special Controls) or class III (Premarket Approval), it II 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. ಡ 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. ln
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Paqe 2 - Mr. Baskaran
this response to your premarket notification Please note: submission does not affect any obligation you might have Submisblon access 130 arough 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 (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,
Timothy A. Ulatowski
thy A. U 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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Indications for use 3.0
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| 510(k) number | : K991750 |
| Device name | : BRIGHTWAY™ Brand Blue ColorLatex Examination Gloves, Powder Freecontaining 50 µgm or less of waterextractable protein per gram. |
Indications for use:
BRIGHTWAY™ Brand Blue Color Latex Examination Glove, Powder BRIGHT WAT - Brand Dide Colors - Entractable protein per gram is
Free containing 50 ugm or less of water extractable process the hond, of Free containing 30 ugin of fess of water of water of the hand of
a disposable patient examination glove which is worn notion between a disposable patient claimination grevent contamination between patient and examiner.
(FLEASE 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
(Optional Format 1-2-96)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
§ 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.