(133 days)
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No
The device description and intended use clearly define it as a standard examination glove, with no mention of AI or ML capabilities.
No
The device is described as a "patient examination glove" intended to prevent contamination, which is a barrier device for medical purposes, not a therapeutic intervention.
No
Explanation: The device is a "patient examination glove," which is a barrier device used to prevent contamination, not to diagnose a condition.
No
The device description clearly states it is a "POWDER-FREE LATEX EXAMINATION GLOVES," which is a physical hardware device, 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 that the device is a "PATIENT EXAMINATION GLOVE" worn on the examiner's hand to prevent contamination. This is a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description "POWDER-FREE LATEX EXAMINATION GLOVES" further supports its function as a physical barrier.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, calibrators, controls, or analysis of biological samples.
Therefore, this device falls under the category of a general medical device, specifically a Class I or Class II medical glove, rather than an IVD.
N/A
Intended Use / Indications for Use
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
Product codes
LYY
Device Description
POWDER-FREE LATEX EXAMINATION GLOVES
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1997
Mr. Clement K.K. Oon Executive Director Oon Corporation Resources (M) SDN BHD-Lot No. 59, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus Malaysia
Re : K970770 Latex Examination Gloves, Powderfree Trade Name: Regulatory Class: I Product Code: LYY Dated: May 8, 1997 Received: June 16, 1997
Dear Mr. Oon:
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. ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Oon
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described.in.your 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 requlation (21 CFR Part 801 and additionally 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" (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,
K. Olstad
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
FDA/QDE/DDIGD
K970770 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: POWDER-FREE LATEX EXAMINATION GLOVES
Indications For Usc:
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
(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 Dental, Infection Control,
and Genera! Hospital Devices
5:04) Number K970770
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use V
(Optional Format 1-2-96)