(28 days)
Not Found
Not Found
No
The summary describes a standard 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 "Intended Use" states that the device is a glove worn by personnel to prevent contamination, which is a barrier function, not a therapeutic one. It does not treat, cure, mitigate, or prevent disease in a therapeutic sense.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states it is a physical examination glove, which is a hardware component. There is no mention of software functionality.
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 healthcare personnel and the patient by being worn as a glove. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: The document lacks any mention of:
- Image processing, AI, DNN, or ML: These are often associated with advanced IVD systems.
- Input Imaging Modality: IVDs can involve imaging, but this device does not.
- Anatomical Site: While the glove is used on the hands, it's not for examining or testing a specific anatomical site for diagnostic purposes.
- Performance Studies/Metrics: IVDs require rigorous performance studies (sensitivity, specificity, etc.) to demonstrate their diagnostic accuracy. These are not mentioned.
In summary, the device is a physical barrier intended for infection control, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient".
Product codes
LYY
Device Description
Powder-free Chlorinated Latex Examination Gloves With Protein 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
healthcare or similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
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.
Not Found
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.
Not Found
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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1999
Mr. Tan Penq Hock Managing Director Glovco (M) Sdn. Bhd. Lot 760, Jalan Haji Sirat Off Jalan Meru Klang, Selangor D.E., Malaysia
K993752 Re: Powder-free Chlorinated Latex Examination Trade Name: Gloves With Protein Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY October 25, 1999 Dated: November 5, 1999 Received:
Dear Mr. Hock:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Mr. Hock
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 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 regulation (21 CFR Part 801 and additionally 809.10 for in yitro diaqnostic 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 gener 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, Univer
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
PREMARKET NOTIFICATION [510(K)] FOR POWDER-FREE CHLORINATED LÀTËX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Applicant : GLOVCO (M) SDN BHD. : OCTOBER 25, 1999. Date
Page 5 of 11
3.0 INDICATION FOR USE
: _ Kag 3752 510(K) Number (If known) : Powder-free Chlorinated Latex Examination Gloves with Proteing Device Name r gra Labeling Claim Indications For Use:
"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient".
(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 X
(Optional Format 1-2-96)
Clim S. Lin
Sign-Off)
of Dental, Infection Control,
Hospital Devices
mber K993752