(36 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
POWDERED NITRILE EXAMINATION GLOVE
I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Nitrile Examination Glove, not a medical device that uses AI or requires a study with acceptance criteria and performance metrics in the way you've described.
The document discusses:
- The FDA's review of a 510(k) notification.
- The determination of substantial equivalence to a legally marketed predicate device.
- Regulatory classifications and general controls provisions of the Act.
- Indications for use for the glove: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
Therefore, I cannot provide the information you requested about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because it is not relevant to the subject matter of this document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Mr. T. S. Puon Factory Manager Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru 41050 Klang, Selangor D.E. MALAYSIA
K983816 Re : Nitrile Examination Glove, Powdered Trade Name: Requlatory Class: I Product Code: LZA Dated: October 21, 1998 October 29, 1998 Received:
Dear Mr. Puon:
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 abe beacudin 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 Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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. Please note: concerning your device in the Federal Register. 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. Puon
through 542 of the Act for devices under the Electronic enrough 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 as 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/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
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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant; __ TOP GLOVE SDN. BHD.
510(k) Number (if known): -----
Device Name: ____ POWDERED NITRILE EXAMINATION GLOVE
Indications For Use;
This glove is disposable and intended for medical purpose that is worn on the examiner's hand 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)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K983816 | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use | OR | Over-The-Counter |
|---|---|---|
| Per 21 CFR 801.109 | (Optional Format 1-2-96) |
§ For a new submission, do NOT fill in the 510(k) number blank.
- For a new submission, do NO'l' fill in the 510(k) number blank.
8-8
§ 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.