(44 days)
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Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, or any related technologies.
No.
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a disease or condition.
No
The device is a physical glove, not software. The description clearly states it is a "Smart Glove Latex Pattern Examination Gloves Powderfree".
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 hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a glove made of latex with specific properties (powder-free, low protein). This aligns with a medical device used for protection, not for analyzing biological samples.
- Lack of IVD Characteristics: The document 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 the body
- Providing information for diagnosis, monitoring, or treatment decisions based on laboratory tests.
- Mentions of reagents, assays, or analytical procedures.
Therefore, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This glove Is disposable and is intended for medioal purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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
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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)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on a single line. The text is likely part of a document or sign.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Mr. Foo Knon Pu &J Medical Product SND BHD Lot 723, Batū 5 172, Jālan Kapar, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re : K971403 SMART - GLOVE® Powder-Free Latex Trade Name: Examination Glove with Protein Content Labeling Claim Requlatory Class: I Product Code: Lyy Dated: April 5, 1997 Received: April 15, 1997
Dear Mr. Foo Knon Pu:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಿಗೆ 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 regulation 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 obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Foo Knon Pu
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 debtition in your of your device to a legally marketed bubblance device results in a classification for your device and thus, permits your device to proceed to the market. enab, pormal ( regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. 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). Mibbianant of Iornation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 for (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Collaitrust
Timotiy Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
MEDICAL PRODUCTS (M) SDN. BHD.
(Company No. 176287 H)
| INDICATIONS FOR USE |
|---|
| --------------------- |
Indication For Use Statement.
SJ MEDICAL PRODUCTS (M) SDN BHD Applicant :
: K 971403 510K ( Number )
. .
Device Name
3.0
Smart Glove Latex Patternt Examination Gloves Powderfree, 50 mogm or less water extractable protein.
Indication for Use: This glove Is disposable and is intended for medioal 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 )
Olin S. hin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number KG71403
Proscription Use (Per 21 CFR 801.109) OR
Over - The - Counter Use
19ption Porner 1-2-96)
Lot 723, Batu 51/2, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan. Tel: 603-3915042/3/4 Fax: 603-3915041