(46 days)
Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 µgm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Brightway™ Brand Latex Examination Gloves, Powdered with 150 ugm or less of total water extractable protein per gram
The provided text is a 510(k) premarket notification letter from the FDA to Brightway Holdings Sdn. Bhd. regarding their Brightway™ Brand Latex Powdered Examination Glove. This document is a regulatory approval letter and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report or a technical performance evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document states that the device is "substantially equivalent" to predicate devices, meaning it has been determined to be as safe and effective as a device already legally marketed. This determination is based on the information provided in the 510(k) submission, which would have included performance data, but that data is not detailed in this approval letter.
The relevant information from the document is:
- Device: Brightway™ Brand Latex Powdered Examination Glove (Contains 150 Mcgm or Less of Total Water Extractable Protein Per Gram)
- Regulatory Class: I
- Product Code: LYY
- Indications for Use: "Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 µgm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner."
To answer the questions posed, one would need to refer to the actual 510(k) submission (K990540) itself, which would contain the technical data and studies conducted to demonstrate substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 19 1999
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re : K990540 Brightway™ Brand Latex Powdered Examination Trade Name: Glove (Contains 150 Mcgm or Less of Total Water Extractable Protein Per Gram) Requlatory Class: I Product Code: LYY February 16, 1999 Dated: February 22, 1999 Received:
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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
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Page 2 - Mr. Baskaran
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrood in your tia 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 Other qeneral 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
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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REVISED LABELING : 15TH MARCH 1999 510 (K) NO. : K. 990540 LATEX EXAMINATION GLOVES, POWDERED with 150 ugm or less of total water extractable protein per gram
3.0 Indications for use
Applicant : BRIGHTWAY HOLDINGS SDN. BHD. 510(k) number : K 990540 : Brightway™ Brand Latex Examination Device name Gloves, Powdered with 150 ugm or less
of water extractable protein per gram
Indications for use:
Brightway™ Brand Latex Examination Glove, Powdered is a disposable patient examination glove which contains 150 µgm or less of total extractable protein per gram, that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 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.