(264 days)
A 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.
Patient Examination Glove, Latex, Powder Free
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Patient Examination Glove, Latex, Powder Free." This document explicitly states that the device is substantially equivalent to legally marketed predicate devices. Crucially, it does not contain the specific information required to complete the table and answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.
The letter is an approval for market entry based on substantial equivalence, not a detailed report of a clinical trial or performance study against specific acceptance criteria. The FDA's finding of substantial equivalence means they believe the device is as safe and effective as a legally marketed predicate device, without necessarily requiring a new, comprehensive performance study that would generate the kind of data requested.
Therefore, I cannot extract the requested information from the provided text. The document is about regulatory approval, not a performance study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a person's profile, with the shapes overlapping and flowing together.
Public Health Service
SEP 1 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Liew Yoon Fonq · Executive Director Purnabina SDN. BHD. Plo 5, Jalan Mahsuri 1, 7.5 K.M., Jalan Mersing Kawasan Perindustrian Kluang 86007 Kluang, Johor Darul Takzim MALAYSIA
K994420 Re : Trade Name: Patient Examination Glove, Latex, Powder Free Regulatory Class: I Product Code: LYY Dated: July 26, 2000 Received: August 3, 2000
Dear Mr. Fonq:
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, 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 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 Regulations, 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 regulation (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:
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Page 2 - Mr. Fong
this response to your premarket notification submission does this response to your premains of the have under sections 531 not afrect any obingation for devices under the Electronic through 542 of the net for actions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis lecter will arrow your who are motification. The FDA described in your 510 it, promilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device remates in proceed to the market.
If you desire specific advice for your device on our labeling II you debire upon and additionally 809.10 for in regulacion (21 crk rares), please contact the Office of IIII diagnosere ac (301) 594-4692. Additionally, for questions on Compliance at (501) seetising of your device, please contact the Dromocion and adversibling at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). J Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from the Division on 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Rumas
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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510(k) Number (if known): K994420
Device Name: Patient Examination Glove, Latex, Powder Free
Indications For Use:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bassett In Clin
ision Sien-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K944740
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.