(61 days)
Powdered Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powdered Vinyl Examination Gloves
The provided text describes a 510(k) premarket notification for "Powdered Vinyl Examination Gloves." This document is a regulatory approval letter from the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/software devices.
The FDA 510(k) clearance process demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study in the way AI devices are evaluated.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document. This document pertains to a medical device (examination gloves), not an AI or software device that would typically undergo the types of studies inquiring about.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
Dr. Lim Wee Chai Managing Director Top Glove (Zhangjiagang) Company Limited 3. Zhangjiagang Xi, Tang Road Xi Zhang Town, CHINA 215614
Re: K024016
Trade/Device Name: Powdered Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 27, 2002 Received: December 14, 2002
Dear Dr. Chai:
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.
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Page 2 - Dr. Chai
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); 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), please contact the Office of Compliance at (301) 594-4618. 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | TOP GLOVE (ZHANGJIAGANG) CO. LTD. |
|---|---|
| 510(k) Number (If known): | * |
| Device Name: | POWDERED VINYL EXAMINATION GLOVES |
Indications For Use:
Powdered Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K024016 |
|---|---|
| ---------------- | --------- |
Prescription Use Per 21 CI'R 801.109 ાર
Over-The-Counter _
(Optional Pormal 1.2-96)
- · For a new submission, do NOT fill in the 510(k) number blank.
§ 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.