(27 days)
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No
The summary describes disposable 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
Explanation: The device is described as disposable patient examination gloves, which are used for protection and examination, not for treating or rehabilitating a medical condition.
No
Explanation: The device is a disposable examination glove, which is used for protection during medical examinations, not for diagnosing conditions.
No
The device description clearly states it is "Disposable Powder Free Vinyl Synthetic Examination Gloves," which are physical hardware devices, not software.
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 "DISPOSABLE PATIENT EXAMINATION GLOVES" worn on the examiner's hand or finger for "medical purposes." This describes a physical barrier used during medical examinations, not a device used to test samples from the human body in vitro (outside the body).
- Device Description: The description "Disposable Powder Free Vinyl Synthetic Examination Gloves" further reinforces that this is a physical barrier device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents, calibrators, or controls
Therefore, this device falls under the category of a medical device used for protection and hygiene during examinations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DISPOSABLE DEVICE INTENDED A PATIENT EXAMINATION GLOVES IS A FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Canopus Medical Supply Company Limited C/O Ms. Elizabeth Deng PM Gloves, Incorporated 13808 Magnolia Avenue Chino, California 91710
DEC 1 0 2001
Re: K013753
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 1, 2001 Received: November 13, 2001
Dear Ms. Deng:
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
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Page 2 - Ms. Deng
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Her or any I outh all the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF R Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in adiation 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 This letter will and w you've cognized in the FDA finding of substantial equivalence of your device to 3 rotcy premained no advice 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 If you dosire opeonto and 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 nothernon (11 Cr read from the Division of Small Manufacturers, International and the receints) every 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. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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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 CANOPUS MEDICAL SUPPLY CO., LTD. Applicant: _ Kol3753 510(k) Number (if known): * 510(k) Number (if known): * __________________________________________________________________________________________________________________________________________________ WHITE COLOR Indications For Use:
DISPOSABLE DEVICE INTENDED A PATIENT EXAMINATION GLOVES IS A FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER,
FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter OR Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank. #
Clair S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number