(66 days)
Laglove™ Brand Colored Nitrile Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Blue Colored Nitrile Examination Gloves (Powder-Free)
The provided document is a 510(k) premarket notification letter from the FDA for a device described as "Laglove™ Blue Colored Nitrile Examination Gloves (Powder-Free)". This letter indicates a substantial equivalence determination, allowing the device to be marketed.
However, the document does not contain any information about acceptance criteria, a study proving the device meets those criteria, or details regarding the performance evaluation of the device in the context of your request.
The FDA 510(k) clearance process for devices like examination gloves primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with detailed performance metrics as might be seen for more complex medical devices.
Therefore, I cannot provide the requested information based on the provided input. The document is merely an approval letter, not a study report or a detailed performance and acceptance criteria document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 159
Mr. G. Baskaran Managing Director Laglove (M) Sdn. Bhd. Lot 478, Jalan Simpang Balak, Off Batu 13, Jalan Cheras, 43000 Kajang, Selangor Darul Ehsan MALAYSIA
Re : K990882 Laglove™ Blue Colored Nitrile Examination Trade Name: Gloves (Powder-Free) Requlatory Class: I Product Code: LZA Dated: May 3, 1999 Received: May 16, 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 requlatory 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
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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 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 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,
Susan Quares
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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3.0 Indications for use
Applicant 510(k) number Device name
: LAGLOVE (M) SDN. BHD. : Examination Gloves (Powder Free)
4
:
Indications for use:
Laglove™ Brand Colored Nitrile Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Chin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Over-the-Counter Use ... ্রের প্রতি
§ 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.