(36 days)
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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 device, a patient examination glove, is intended to prevent contamination between healthcare personnel and the patient, which is a barrier function, not a therapeutic intervention.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product (gloves) and there is no mention of software components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to prevent contamination between healthcare personnel and the patient by being worn as a glove. It does not involve the examination of any biological samples.
- The device description is for a glove. Gloves are considered medical devices, but not IVDs.
- There is no mention of any diagnostic testing or analysis. The description focuses on the barrier function of the glove.
Therefore, based on the provided information, this device is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
" A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient".
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
healthcare or similar personnel
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.
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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human figures in profile facing to the right, and a wavy line below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 1999
Mr. Tan Peng Hock Glovco (M) Sdn. Bhd. Lot 760, (Block A) Jalan Haji Sirat, Off Jalan Meru, 42100 Klanq, Selangor Darul Ehsan, MALAYSIA
Re : K991043 Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram) Regulatory Class: I Product Code: LYY Dated: March 19, 1999 March 29 1999 Received:
Dear Mr. Tan Peng 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, 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 Requlations, Title 21, Parts 800 to 895. ਖੇ 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Tan Peng Hock
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 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 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,
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
510(k) Number (if known): K 991043
Device Name: Powdered Latex Examination Gloves with Protein Labeling Claim
Indications For Use:
" A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare 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 8()1.109) OR
Over-The-Counter Use X
(Optional fromat 1-2-96)
Chin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number