(216 days)
A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.
A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.
This document is a 510(k) clearance letter from the FDA for a Powder Free Latex Patient Examination Glove.
Therefore, the input you provided does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML medical device. It's an approval letter for a physical medical product (gloves) and discusses regulatory compliance rather than performance studies with acceptance criteria as typically found for AI.
As such, I cannot extract the information required in your request (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, or ground truth establishment for training set) from this document. This document pertains to the regulatory clearance of a standard medical glove, not an AI/ML device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Anderson Manager of Regulatory Affairs Alatech Healthcare, LLC 1600 State Docks Road Eufaula, Alabama 36027
JUL 2 2 2009
Re: K083761
Trade/Device Name: Powder Free Latex Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: July 2, 2009
Received: July 6, 2009
Dear Mr. Anderson:
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 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. Anderson
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony D. Winter for
Susan Butler, D.D.S., M.S.
Susan Runner, D.D.S., M.A. Acting 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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Indications for Use
Applicant Name ---------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number -----
---- Powder free latex Patient Examination Glove Device Name --
A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.
Prescription Use (part 21 CFR 801 Subpart D) Over the Counter Use X (part 21 CFR 801 Subpart C)
(Please do not write below this line-continue on another page if necessary)
concurrence of CDRH Office of Device Evaluation (ODE)
Shulin Murphy, PC
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental 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.