(46 days)
BRIGHTWAY™ Brand Latex Examination Glove, Powder Free containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Not Found
This document is a 510(k) premarket notification approval letter for "Brightway™ Brand Latex Examination Gloves Powder-Free." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory approval document rather than a study report.
Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 9 1999
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klanq, Selangor Darul Ehsan MALAYSIA
Re : K990539
Brightway™ Brand Latex Examination Trade Name: Gloves Powder-Free (Contains 50 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. 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 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 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 requlation 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
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 : 22"0 MARCH 1999 510 (K) NO. : K 990539 SIV (R) NO. . IN 97650
LATEX EXAMINATION GLOVES ,POWDER FREE containing 50 ugm or less of water extractable protein per gram
3.0 Indications for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| 510(k) number | : K 990539 |
| Device name | : BRIGHTWAY TM Brand Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram. |
Indications for use:
BRIGHTWAY™ Brand Latex Examination Glove, Powder Free containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which 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)
| Phim S. Lim (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K990539 | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use __________ OR __________ Over-The-Counter Use __________
P (Pct 21 CFR 801.109)
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ുന്നു
工程
OR
Over-The-Counter Use X
: /
(Optional Format 1-2-96)
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§ 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.