(187 days)
The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant.
The provided text describes a 510(k) premarket notification for "Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant." This document is a regulatory approval letter from the FDA, and it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.
The product is a physical medical device (gloves), not a software or AI device. Therefore, the requested information about device performance, ground truth, study design, and AI-specific metrics is not applicable to this document.
To answer your specific points based on the provided text:
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A table of acceptance criteria and the reported device performance: Not available. This document is an FDA approval letter for a physical product (gloves), not a performance report for an AI/software device. Acceptance criteria for gloves would typically involve physical properties like tensile strength, freedom from holes, and biocompatibility, which are not detailed here.
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Sample sized used for the test set and the data provenance: Not applicable. There is no test set for an AI model.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for a physical glove in the context of an AI model.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
The document primarily states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs as intended and is as safe and effective as existing products. It mentions the "Indications for Use" (prevent contamination between patient and examiner) but does not provide performance metrics or study details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 07,2013
Ms. Nurul Aisyah Kong Quality Assurance Senior Manager Hartalega Sdn. Bhd. No. 7 Kawasan Perusahaan Suria 45600 Bestari Jaya Selangor, Malaysia
Re: K123368
Trade/Device Name: Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 13, 2013
Received: March 25, 2013
Dear Ms. Kong:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Kong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
for
Thith
urohits.
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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510(k) Number (if known): K123368
Device Name:
Latex Powder Free Examination Gloves with Colloidal Catmeal USP Skin Protectant.
Indications for Use:
The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device 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 X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
������������������������������������������������ Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Elizabeth F. Claverie Elizabeth DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130005586 Claverie 4, cn=Elizabeth F. Claverie Date: 2013:05.06 17:07:18 -04'00" (Division Sign-Off) Page __ of (Division Sign-On) Intection Control, Dental Devices K123368 510(k) Number:
Attachment 1.0 - 2
§ 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.