(18 days)
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange)
The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. for "Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange". This document approves the device for market based on substantial equivalence to a predicate device.
It does NOT contain the type of acceptance criteria, study details, or performance data typically found for AI/ML-based medical devices. The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA) or extensive clinical trials as would be the case for novel AI.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This information is simply not present in the provided text.
The document discusses regulatory classification (Class I), general controls, and compliance requirements, but not the technical performance metrics of the gloves themselves.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2002
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah, 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K022878
Trade/Device Name: Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 23, 2002 Received: August 30, 2002
Dear Mr. Baskaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Baskaran
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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? " Indication for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD |
|---|---|
| 510(K) No | : K022878 |
| Device Name | : Brighway TM Brand Colored Powder FreeNitrile Examination Gloves (Orange) |
Indication for use
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Qiu Si Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K022828
§ 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.