(87 days)
A patient examination Vinyl Powder Free Gloves is a disposable device Intended for medical patient and examiner. A patient examination vinyl in the is worn on the examiner' device Intended for medical patient and examiner.
Powder Free Vinyl Examination Glove
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Glove" and an "Indications for Use" statement.
This document does not contain information about the acceptance criteria and study results for an AI/device's performance as typically requested for medical AI devices. It details the FDA's decision regarding substantial equivalence for a medical glove, which is a physical device, not a software or AI-driven diagnostic tool.
Therefore, I cannot extract the requested information such as test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Mr. Wu Kin Yeap General Manager TG Medical (China) Incorporated 3, Xitang Road, Xizhang Town Zhangjiagang, Jiangsu Province 215614 China
Re: K052985
Trade/Device Name: Powder Free Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 12, 2006 Reccived: January 17, 2006
Dear Mr. Yeap:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 cither 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 8010 161598. In addition, FDA may publish further announcements concerning your device in the Foresal Register.
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Page 2 - Mr. Yeap
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 on quirements of the Act or any Federal statutes and regulations administered by other Federal reqencies. 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 proctice 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 1,c1); 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, purmits 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly vours.
Snea y. Michael Davis
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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Indications for Use
510(k) Number (if known): K052985
Device Name: Powder Free Vinyl Examination Glove
Indications For Use:
A patient examination Vinyl Powder Free Gľoves is a disposable A pattent examination viny in the is worn on the examiner' device Intended for medical 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 M. Murphy, MD 1/19/06
Radiology, General Hospital,
Control, Dental Devices
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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.