(39 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Powder Free Nitrile Examination Gloves
The provided document is a 510(k) clearance letter from the FDA for "Blue Powder-Free Nitrile Examination Gloves." This type of document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device.
The FDA 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically involve detailed performance studies with acceptance criteria in the way an AI/software as a medical device (SaMD) would. Instead, substantial equivalence is often based on material properties, design, manufacturing processes, and adherence to recognized standards for physical characteristics (like tensile strength, puncture resistance, etc.).
Therefore, I cannot provide the requested information based on the given document.
To clarify for future reference, if you were to provide a document describing an AI/SaMD, the typical information you'd look for to answer your request would include:
- Acceptance Criteria Table: A table explicitly listing performance metrics (e.g., sensitivity, specificity, AUC) and their target values.
- Study Design Section: Details on the prospective/retrospective nature of the study, data sources (countries, institutions), and the size of the test set.
- Ground Truth Establishment: How the ground truth for the test set was determined, including the number and qualifications of experts involved.
- Adjudication Method: If multiple experts were used, how disagreements were resolved (e.g., 2+1, 3+1).
- Comparative Effectiveness Study: Information on MRMC studies, if conducted, and the reported improvement of human readers with AI assistance.
- Standalone Performance: If the algorithm's performance was evaluated independently without human intervention.
- Type of Ground Truth: The gold standard used for ground truth (e.g., pathology, surgical findings, long-term follow-up).
- Training Set Details: The size of the dataset used to train the AI model.
- Training Set Ground Truth: How the ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1999
Mr. Kuan Kam Hon QA Manager Hartalega Sdn. Bhd. 9 Jalan Kuang Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, MALAYSIA
K990283 Re : Blue Powder-Free Nitrile Examination Trade Name: Gloves Regulatory Class: I Product Code: LZA Dated: January 27, 1999 January 29, 1999 Received:
Dear Mr. 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 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. ਕੇ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Hon
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 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" (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.fdaj.gov/cdr/h/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1988 - 1997 .
510(k) Number (if known) : K990283
Device Name : Blue Powder Free Nitrile Examination Gloves
Indications For Use :
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Clim S. Lin
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 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.