(41 days)
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Not Found
No
The device description and intended use clearly define a standard patient examination glove, with no mention of AI or ML capabilities.
No
This device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or alleviate a medical condition.
No
Explanation: The device is described as a "patient examination glove," which is used to prevent contamination between patient and examiner. Its intended use does not involve diagnosing medical conditions, but rather providing a barrier during examinations.
No
The device is a physical patient examination glove, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Description and Intended Use: The description clearly states that this is a "patient examination glove" intended to be "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a physical barrier device used for infection control.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information. It does not analyze any substances or markers from the patient.
Therefore, based on the provided information, this device falls under the category of a medical device used for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LYY
Device Description
Latex Patient Examination Glove with protein content Powdered labeling claim (150 µg/g glove or less)
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
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
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three overlapping, curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Mr. Bob Chan General Manager Kossan Latex Industries (M) Sdn. Bhd. Lot 16632, 5¼ Miles, Jalan Meru, 41050 Klang Selangor Darul Ehsan, MALAYSIA
K984020 Re : Powdered Latex Examination Glove Trade Name: with Protein Content Labeling Claim (150 micrograms or less) Regulatory Class: I Product Code: LYY November 7, 1998 Dated: November 12, 1998 Received:
Dear Mr. Chan:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Chan:
through 542 of the Act for devices under the Electronic Chrough 542 or the not on provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Info recei will aremarket notification. The FDA described in your Sioth, prematics of your device to a legally marketed predicate device results in a classification for your marketed predicate device rubated in the to proceed to the market.
If you desire specific advice for your device on our labeling If you debite bpcorres and additionally 809.10 for in regulation (2) er erdevices), please contact the Office of Victo diagnobero at (301) 594-4692. Additionally, for questions on Compriance at (50x) dvertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the office or comparied, "Misbranding by reference to ene regalablie in (21CFR 807.97). Other general premation on your responsibilities under the Act may be firstmation on your copyon of Small Manufacturers Assistance obtained from the biving (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamafin.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
Section 3
Page 1 of 1
510 (K) Number (if known): K 984020
Device Name : Latex Patient Examination Glove with protein content
Powdered
labeling claim (150 µg/g glove or less)
Indications For Use
ﺗﺮﻳﺒﺎ
ﺍﻟﻤﻨﺘﺠ
A 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.
(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 ) OR
Over-The-Counter Use
( Optional Format 1-2-96 )
Hamilsty Cilim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _