(108 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification from the FDA, approving the marketing of Matang Powder-Free Latex Patient Examination Gloves with a protein labeling claim. It does not contain the detailed study information typically requested for AI/ML device evaluations. Therefore, I cannot provide the specific information requested in the prompt based on this document.
The document primarily focuses on the regulatory approval process for a medical device (latex gloves) and confirms its substantial equivalence to a legally marketed predicate device. It does not include data from a study on device performance against specific acceptance criteria in the way an AI/ML device submission would.
To answer your prompt, I would need a document that presents the results of a study designed to demonstrate the performance of a device (likely an AI/ML device) against predefined acceptance criteria.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Matang Manufacturing Sdn. Bhd. C/O Mr. Kok-Kee Hon Official Correspondent 6324 Meeting House Way Alexandria, Virginia 22312-1718
Re : K982877 Trade Name: Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: November 14, 1998 November 16, 1998 Received:
Dear Mr. Kok-Kee Hon:
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 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, Druq, 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Kok-Kee Hon
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation (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" (21CFR 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/dsma/dsmama/n.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A . Ülatowski Directpr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 2 Amended 10/23/98
INDICATIONS FOR USE
Matang Manufacturing Sdn Bhd Applicant :
510 (k) Number (if known) : K982877
. Restring Latex Latex Examination Gloves (1917) Less) Device Name : PROTEIN LABELING CLAIM (50 MICROGR
Indications For Use :
A medical glove is worn on the hand of healthcare and
similar personnel to prevent contamination between
healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin Si Lin
(Division Sign-Off) (Division Sign of Dental, Infection Control, and General Hospital Device 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
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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.