(64 days)
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No
The 510(k) summary describes a standard patient examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a Patient Examination Glove, intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No
Explanation: The device is described as a glove for preventing contamination, not for diagnosing medical conditions.
No
The device is described as a "Patient Examination Glove," which is a physical, disposable item worn on the hand. This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally during patient examination.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.
Product codes
LYY
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
Hand or finger
Indicated Patient Age Range
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Intended User / Care Setting
medical purposes / 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.)
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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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Guthrie Medicare Products (NS) SDN BHD c/o Susan D. Goldstein-Falk Official Correspondent for Guthrie Medicare Products (NS) SDN BHD MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re : K993793 Pre-powdered latex patient examination glove Trade Name: Regulatory Class: I Product Code: LYY Dated: November 5, 1999 Received: November 9, 1999
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨੂੰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Goldstein-Falk
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeins 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
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 the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
GUTHRIE MEDICARE PRODUCTS (NS) SDN BHD Applicant: __ 510(k) Number (if, known) Devici: Name of Pationt Latex Examination Glove Indications For Use:
Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109 (Optional Formal 1-2-96) **
Over-The-Counter
For a new submission, do NOT fill in the 510(k) number blank.
Qhin S. Lim
(Division Sign-Off) Division of Dental, Infection Control. and General Hospjtal I 510(k) Number
t