(80 days)
A vinyl 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.
POWDER-FREE ELASTIC VINYL EXAMINATION GLOVES
The provided text is a 510(k) premarket notification approval letter for "Powder-Free Elastic Vinyl Examination Gloves". This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The information requested in the prompt (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in clinical validation studies for AI/ML medical devices. This document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. W. J. Hu President -Sun Flower Gloves Company Limited 187. Chien-Yeh Road, Shan-Hua, Tainan Hsien, TAWIAN, R.O.C
Re: K022604
Trade/Device Name: Powder-Free Elastic Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYZ Dated: October 5, 2002 Received: October 10, 2002
Dear Mr. Hu:
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 such 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.
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.
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Page 2 - Mr. Hu
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 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.
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. permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulteig
Timothy A. Ulatowski 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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Image /page/2/Picture/0 description: The image shows a drawing of a sunflower with the word "Sunflower" written next to it. The word "Sun" is written above the word "Flower". The sunflower has a smiling face in the center and petals around it.
SUN FLOWER GLOVES CO., LTD.
187, CHIEN-YEH RD., SHAN-HUA, TAINAN HSIEN,
e-mail:sftaiwan@ms27.hinet.net TAIWAN, R.O.C.
善化手套興業股份有限公司 741 台南縣善化鎭建業路187號
TEL(06)5830767-8 FAX(06)5830737
| 510(k) NUMBER (IF KNOWN): | K022604 |
|---|---|
| --------------------------- | --------- |
POWDER-FREE ELASTIC VINYL EXAMINATION GLOVES DEVICE NAME:
STATEMENT OF INDICATIONS FOR USE [ 807.92 (a) (5) ].
A vinyl 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter-Use | |||
|---|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||||
| (Division Sign-Off) | |||||
| Division of Anesthesiology, General Hospital, | |||||
| Infection Control, Dental Devices | |||||
| S Lin |
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.