(27 days)
Laglove™ Brand Polymer Coated Latex examination glove (powder free) is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Brand Polymer Coated Latex Examination Glove (Powder-Free) Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Laglove™ Brand Polymer Coated Latex Examination Glove (Powder-Free)". It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed study parameters you've requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.).
The letter primarily focuses on:
- Regulatory status: Classification as Class I and substantial equivalence to predicate devices.
- General controls: Requirements for annual registration, listing of devices, GMP, labeling, and prohibitions against misbranding and adulteration.
- Marketing permission: Granting permission to market the device.
To answer your request, I would need a document that describes the performance study conducted for these gloves, including the data you've asked for. This FDA letter simply states that the device is "substantially equivalent" based on information they reviewed, but it does not detail what that information was in terms of a performance study and its methodology.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
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
K990268 Re :
Laglove™ Brand Polymer Coated Latex Trade Name: Examination Glove (Powder-Free) Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY January 25, 1999 Dated: Received: January 28, 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 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 Requlations, 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
{1}------------------------------------------------
Page 2 - Mr. Baskaran
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 acboring 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.fdaffgov/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
{2}------------------------------------------------
3.0 Indications for use
: LAGLOVE (M) SDN. BHD.
Applicant 510(k) number Device name
Indications for use:
Laglove™ Coated Latex Polymer Brand (Powder Free) Examination -Gloves Profein claim of somegen are less of Total water sytractable professo per quam
Laglove™ Brand Polymer Coated Latex examination glove (powder Lagiove - Drand Forymer 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)
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
?rescription Use Per 21 CFR 801.109)
OR
Olin S. Lin
Over-The-Counter Use X
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
(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.