(401 days)
Not Found
Not Found
No
The summary describes a disposable examination glove and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device, a patient examination glove, is intended to prevent contamination and is not described as treating or alleviating a medical condition.
No
The device is described as a "patient examination glove" used to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a "DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES," which are physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "PATIENT EXAMINATION GLOVE" worn on the hand or fingers to prevent contamination. This is a physical barrier device used during patient examination.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis on bodily specimens.
- Device Description: The description confirms it's a "DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES". This aligns with a physical barrier device, not an analytical one.
- Lack of IVD Characteristics: The document lacks any mention of typical IVD characteristics such as:
- Analysis of biological samples
- Reagents or assays
- Measurement of analytes
- Diagnostic or screening purposes based on sample analysis
Therefore, the device described is a medical device used for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
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
EXAMINER'S HAND OR FINGERS
Indicated Patient Age Range
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Intended User / Care Setting
EXAMINER
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
Not Found
§ 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.
0
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Mr. Rudy Lin Manager Canopus Medical Supply Company Limited 10th Floor, No.201, Fu Hsing North Road, Taipei 105, Taiwan, R.O.C.
Re: K023452
Trade/Device Name: Opus-E Disposable powder Free Vinyl synthetic Exam Gloves with Nopal & Vitamin E Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 15, 2003 Received: September 24, 2003
Dear Mr. Lin:
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 - Mr. Lin
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 Runns
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
2
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: CANOPUS MEDICAL SUPPLY CO., LTD. | |
|---|---|
| The State of Children of Children and Children and Children and Children and Children of Children of Children of Children of Children of Children of Children of Children of C |
510(k) Number (if known):
Device Name: OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOYES & Nopal + Vitamin C
Kr23452
Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Susanna Baru W
Anesthesiology, General Hospital, ontrol, Dental Devices
510(k) Number:
*For a new submission, do NOT fill in the 510(k) number. Original Report Page 4