(83 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.
Powdered Latex Examination Gloves
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
The document is a US FDA 510(k) clearance letter for "Powdered Latex Examination Gloves," dated February 9, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.
Here's what the document does include:
- Device Name: Powdered Latex Examination Gloves
- Regulatory Class: I
- Product Code: LYY
- 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."
- Applicant: Kilang Barangan Getah Dioh
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, as it is not an AI-based device.
- Information on a standalone algorithm performance.
- Type of ground truth used (as it's not an AI device, this is not applicable in the way you're asking).
- Sample size for the training set (not applicable for this type of device).
- How the ground truth for the training set was established (not applicable for this type of device).
The 510(k) clearance process for this type of device (Class I examination gloves) primarily relies on demonstrating substantial equivalence to a predicate device, which often involves showing that the device meets recognized international or national standards for performance (e.g., ASTM standards for barrier integrity, dimensions, etc.) rather than clinical studies with expert ground truth or AI performance metrics.
To get the kind of information you are asking for, you would typically need a more detailed study report or a 510(k) summary for a more complex device, particularly one involving AI or diagnostic imaging.
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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 features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Mr. Norli Bin Manaff General Manager Kilang Barangan Getah Dioh Lot 9, Kawasan Perindustrian Dioh 72000 Kuala Pilah, Negeri Sembilan Darul Khusus MALAYSIA
Re : K984125 Powdered Latex Examination Gloves, Non-Trade Name: Sterile Regulatory Class: I Product Code: LYY Dated: January 5, 1999 Received: January 14, 1999
Dear Mr. Manaff:
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 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 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 requlation 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. Manaff
through 542 of the Act for devices under the Electronic Chrough 542 or the net 101 xevisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis lecter will arrow your on responsibilication. The FDA described in your six in puivalence of your device to a legally Finding of Bubbeaneral ogaresults in a classification for your marketed predicate device robated in the to proceed to the market.
If you desire specific advice for your device on our labeling II you debire opeonate and additionally 809.10 for in regaraciasmostic devices), please contact the Office of Villo draghosere actrices// productionally, for questions on Compriance at (30), and advertising of your device, please contact che promotion and advences (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 Information on your responsible of Small Manufacturers Assistance obcation from eno umber (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Tim 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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INDICATIONS FOR USE
Applicant : Kilang Barangan Getah Dioh
K984125 510(k) Number (if known) :
Device Name : _ Powdered Latex Examination Gloves
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 BELEOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off)
Division of Denial. Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
(Optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(k) number blank.
§ 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.