(61 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Black and Gray Color
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Black and Gray Color". This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth for AI/device performance.
The letter confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists regulations and requirements that the manufacturer must comply with, but it does not detail the technical performance criteria or the studies used to demonstrate that performance.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a performance report.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. This type of study is not relevant for basic examination gloves.
- If a standalone performance study was done: Not present in this document.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
This document serves as an FDA clearance for a medical device (examination gloves) based on substantial equivalence, and it does not delve into the detailed performance metrics or study methodologies typically associated with software as a medical device (SaMD) or AI-based devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Mr. Cho Sow Fong QA/RA Manager Smart Glove Corporation Sdn. Bhd. Lot No. 6487, Batu 5 ¾, Sementa, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K060724
Trade/Device Name: Powder Free Nitrile Examination Gloves, Black and Gray Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 10, 2006 Received: May 12, 2006
Dear Mr. Sow Fong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Sow Fong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suate H. Michael Dus,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
HFZ-401 DMC cc:
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Indications for Use
510(k) Number (if known): K060724
Device Name: Powder Free Nitrile Examination Gloves, Black and Gray Color Indications For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shu. R. Murphy, 40 5/14/06
General Hospital sion of Anesthesiology, School Control. k) Number
Page 1 of
§ 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.