(44 days)
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No
The summary describes a standard medical examination glove and contains no mention of AI, ML, or related technologies.
No
The device, a disposable examination glove, is intended for preventing contamination, not for treating or curing a disease or condition. This falls under barrier protection, not therapeutic intervention.
No
Explanation: The device is described as a glove intended to prevent contamination, which is a barrier function, not a diagnostic one. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device is a physical glove, not software. The description clearly states it is a "Pre-Powdered Nitrile Examination Glove" and is "worn on the examiner's hand".
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: It's described as "Pre-Powdered Nitrile Examination Gloves," which are a physical barrier device.
- Lack of IVD Characteristics: The description 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 perform tests on samples taken from the human body to provide information about a person's health. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 features a stylized eagle or bird design, composed of three curved lines that suggest the shape of a bird in flight. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1999 APR
Mr. Kenny H. N. Liew Executive Director FLEXITECH SDN. SDN.BHD. Lot 5071, Batu 5 1/2 Jalan Meru, 41050 Klang, Selangor Darul Ehsan, MALAYSIA
K990499 Re : Pre-Powdered Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZA February 12, 1999 Dated: February 17, 1999 Received:
Dear Mr. Kenny H. N. Liew
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 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) 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 requlatory 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. Kenny H. N. Liew
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 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,
Patrice Cucurachi/for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "FLEXI" in a bold, sans-serif font, stacked above a rectangular shape. The rectangle is divided into two sections, with the left section being white and the right section being black. The overall design is simple and graphic, with a focus on strong contrast and clear typography.
FLEXITECH SDN. BHD.
Company No: 165532 - M Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: 03-6372878-Fax: 03-6379878 NEW TEL : 603 3920188 FAX : 603 3920228
3.0
Indications for Use Statement.
Page 3 of 45
INDICATIONS FOR USE
FLEXITECH SDN BHD Applicant :
510(k) Number K9904999
Pre Powdered Nitrile Examination Gloves . Device Name:
Indication For Use :
This glove is disposable and intended for medical purpose 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)
Chun S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
OR
scription Use 1 er 21 CFR 801.109 Over-The-Counter : (Optional Format 1-2-96)