(65 days)
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Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts.
No.
The device, an examination glove, is intended to prevent contamination between the patient and examiner, which is a protective function rather than a therapeutic one.
No
Explanation: The device is a "patient examination globes" which are used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, which is a hardware medical 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 is to prevent contamination between patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a glove, a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Chlorinated Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms 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
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental purposes
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Mr. Kuan Kam Hon Hartalega Sdn. Bhd. 9 Jalan Kuang Bulan Taman Keponq Industrial Estate 52100 Kuala Lumpur MALAYSIA
K991616 Re : Chlorinated Powder Free Latex Examination Trade Name: Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: June 11, 1999 Received: June 18, 1999
Dear Mr. Kuan Kam Hon:
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, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ 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.
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Page 2 - Mr. Kuan Kam Hon
this response to your premarket notification Please note: submission does not affect any 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 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) 594-4692. 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 the regulacion chercica) 11582 andrig by Socher 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
Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Examination Glove With Protein Chlorinated Powder-Free Latex Content Labeling Claim (50 Micrograms or less)
Indications For Use : 6.0
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand 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)
Olius S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)