(31 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.
Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White color.
The provided document is an FDA 510(k) Pre-market Notification letter for Polymer Coated Powder Free Nitrile Examination Gloves. This type of document is a regulatory approval and does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.
The questions you've asked are typical for studies evaluating the performance of algorithms or diagnostic devices (often involving AI/ML), where there's a need to establish sensitivity, specificity, accuracy, and compare to a ground truth established by experts.
This document, however, pertains to a physical medical device (examination gloves) and focuses on substantial equivalence to a predicate device, as per the FDA 510(k) process for Class I devices. The "performance" for such a device is typically assessed through physical properties and safety standards, rather than diagnostic accuracy metrics.
Therefore, I cannot extract the requested information from this document.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2005
Mr. So Soon Cheaw General Manager Platinum Glove Industries SDN BHD 4015A, 4 Floor, President House, Jalan Sultan Ismail 50250 Kuala Lumpur MALAYSIA
Re: K051317
Trade/Device Name: Polymer Coated Powder Free Nitrile Examination Gloves, Blue, and White Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 17, 2005 Received: May 23, 2005
Dear Mr. Cheaw:
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 Eederal Register.
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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,
Sayite y. Michie Omd.
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
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3.0 Indication for Use Statement:
INDICATIONS FOR USE
510(k) Number (if known) : KOS | 3 | 7
Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White Device Name: color .
Indication 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Shula H. Murphy, R.D. 4/17/15
ision Sign-Off) Anesthesiology, General Hospital, rol. Dental I Infection
Page 1 of _
510(k) Number: K051317
§ 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.