(66 days)
Not Found
Not Found
No
The 510(k) summary describes examination gloves, which are a simple barrier device and do not involve complex data processing or algorithmic decision-making. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device, Powderfree Vinyl Examination Gloves, is intended to prevent contamination and is not described as providing therapy or treatment.
No
Explanation: The device, Powderfree Vinyl Examination Gloves, is intended to prevent contamination and is worn on the hands. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device is described as "Powderfree Vinyl Examination Gloves," which are physical hardware. The description does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status, disease, or condition.
- Device Type: Examination gloves are considered medical devices, but they fall under a different classification than IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description clearly does not fit the function of examination gloves.
N/A
Intended Use / Indications for Use
Powderfree Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
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Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its back, representing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2003
Dr. Lim Wee Chai Managing Director Top Glove (Zhangjiagang) Company Limited 3, XiTang Road, XiZhang Town, Zhangjiagang 215614 JiangSu, CHINA
Re: K024216
Trade/Device Name: Top Glove Powder-Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 14, 2002 Received: December 23, 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 vour 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 3 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 Runner
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
Enclosure
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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. |
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510(k) Number (If known): | K024216 |
Device Name: | POWDERFREE VINYL EXAMINATION GLOVES |
Indications For Use:Powderfree 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)
Rhu S. Lim
of Anesthesiology, General Hosp Control, Denta
510(k) Number K224216
Prescription Use Per 21 CI'R 801.109
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Over-11ie-Counter
(Optional Former 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank.