(31 days)
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No
The document describes a simple medical device (examination gloves) and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics associated with AI/ML algorithms.
No
The device, "PATIENT EXAMINATION GLOVES," is described as a disposable device intended for medical purposes to prevent contamination between patient and examiner. It does not provide any therapeutic benefit or treatment. Its primary function is a barrier for protection.
No
Explanation: The device is a "PATIENT EXAMINATION GLOVES" and its intended use is to prevent contamination, not to diagnose any condition.
No
The device description clearly states it is "NITRILE EXAMINATION GLOVES -POWDER FREE," which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description "NITRILE EXAMINATION GLOVES -POWDER FREE" further reinforces that this is a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXIMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER
Product codes
LZA
Device Description
Nitrile Examination Gloves, Powder-Free
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 / Medical 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)
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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 stylized caduceus, which is a symbol of medicine, with three intertwined strands. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gan Soong Tee Managing Director Influx Pacific Sdn. Bhd. Lot 61, Jalan Usaha 9, Air Keroh Industrial Estate Malacca, West Malaysia Malaysia
MAR 1 3 1998
Re: K980511 Nitrile Examination Gloves, Powder-Free Trade Name: Requlatory Class: I Product Code: LZA February 5, 1998 Dated: February 10, 1998 Received:
Dear Mr. Tee:
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 aqainst 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq 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 Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Tee
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) 594-4618. 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
Timothy A. " Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
INDICATIONS FOR USE
INFLUX PACIFIC SDN. BHD.
510(k) Number (if known): .
Device Name:
Applicant:
NITRILE EXAMINATION GLOVES -POWDER FREE
Indications Por Use:
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXIMINER'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)
Olim S. Lim
(Division Sign-Off) Division of Dental, Int etion Control, and General Hospit 510(k) Number .
Prescription Use Per 21 CPR 801.109 OR
Over-The-Counter
(Optional Pormat 1-2-95)