(242 days)
A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.
Not Found
The provided text is a 510(k) premarket notification for "Midas Touch™ Nitrile Examination Gloves - Powder-Free, Orange." This document is a regulatory submission for a medical device and does not contain information about a study proving the device meets acceptance criteria in the format typically found for AI/ML-based medical devices.
Instead, this document focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices like gloves. It confirms that the device is intended for medical purposes, to be worn on the hand or finger to prevent contamination between patient and examiner.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, as this document pertains to a physical medical device (gloves).
Here's why the requested information categories are not applicable to the provided document:
- A table of acceptance criteria and the reported device performance: This document doesn't provide performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). For gloves, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), tensile strength, elongation, etc., which are not detailed here beyond the general claim of being "powder-free" and available in sizes.
- Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the context of an AI/ML algorithm.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth, in the AI/ML sense, is not established for gloves.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to examination gloves.
- Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. There's no AI model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval for examination gloves and does not contain the kind of study data requested for AI/ML device performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
Mr. S. N. Hari Deputy General Manager Industrial Clothings, Limited D-17, Seethawaka Export Processing Zone Avissawella Western Province Sri Lanka 10700
Re: K122464
Trade/Device Name: Midas Touch™ Nitrile Examination Gloves- Powder-Free, Orange Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 22, 2013 Received: April 1, 2013
Dear Mr. Hari:
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. 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 - Mr. S. N. Hari
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
for
Ruth
Lurotms.
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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Image /page/2/Picture/0 description: The image shows the logo for "MIDAS SAFETY INNOVATIVE SAFETY SOLUTIONS". The logo features a stylized hand graphic on the left, followed by the word "MIDAS" in large, bold letters. Below "MIDAS" is the word "SAFETY" in smaller letters, and below that is the phrase "INNOVATIVE SAFETY SOLUTIONS".
Industrial Clothings Limited (Prime Polymers Division)
510(k) Submission for Orange Nitrile Examination Gloves - Powder free
INDICATIONS FOR USE
| Applicant | : Industrial Clothings Ltd., Prime Polymers Division |
|---|---|
| 510(k) number (if known) | : K122464 |
| Device name | : Midas TouchTM - Nitrile Examination Gloves -Powder free, Orange |
| Indications for use | : A powder-free examination glove is a disposabledevice intended for medical purposes, that is worn onthe examiner's hand or finger to preventcontamination between patient and examiner. Glovesare available with finger textured surface in foursizes; Small, Medium, Large and X-large. |
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use ✓(21 CFR 801 Subpart C) |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Maria Cruz-fisher(Division Sign-Off) | Digitally signed by Maria Cruz-fisherDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Maria Cruz-fisher,0.9.2342.19200300.100.1.1=2000576169Date: 2013.04.11 16:56:12 -04'00' |
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | K122464 |
ONPF
R122404
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§ 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.