(70 days)
A patient examination Vinyl Powdered Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent the examination in the ad examiner intended for medical purpose and examiner.
Vinyl Powdered Examination Glove
The provided text is a 510(k) clearance letter from the FDA for a Vinyl Powdered Examination Glove. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details for an AI/device.
Instead, the document primarily:
- Confirms the substantial equivalence of the device to pre-existing legally marketed devices.
- Outlines post-market regulatory requirements for the manufacturer.
- Specifies the "Indications for Use" for the glove.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study details based on the provided input. This document is a regulatory approval letter, not a technical report or clinical study summary for an AI/device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, with the department's name encircling the image. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2009
Mr. Tan Chee Hoong Senior Operation Manager Shun Tong Company, Limited North of Gao Xing Tong Road Economic Developing District Xinghua City, Jiangsu China 225700
Re: K091384
Trade/Device Name: Vinyl Powdered Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 1, 2009 Received: July 6, 2009
Dear Mr. Hoong:
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 vour device in the Federal Register.
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Page 2- Mr. Hoong
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 yours,
Anthony D. Hunter Jr.
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
K091384 510(k) Number (if known): _
Device Name: Vinyl Powdered Examination Glove_
Indications for Use:
A patient examination Vinyl Powdered Examination Glove is a disposable device
s and the country of the examplet is worp on the examiner's hand to prevent A patient examination Vinyl Powdered Examiner's hand to prevent
intended for medical purpose that is worn on the examiner's hand to prevent
the examination in the ad examiner intended for medical purpose 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 (
OF NEWS) OF WRITE BELOW OF NEEDED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shadi M. Murphy, MD
09/384
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital infection Control, Dental Devices
Page of
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.