(129 days)
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No
The document describes examination gloves, which are a simple barrier device and do not mention any AI/ML components or functionalities.
No
The device, an examination glove, is intended to prevent contamination, not to treat a disease or condition.
No
Explanation: The device, "Examination Gloves," is described as a disposable barrier to prevent contamination, not a tool for diagnosing medical conditions.
No
The device description clearly states it is "UNIJECT EXAMINATION GLOVES POWDER FREE," which are physical examination gloves, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The description clearly states the device is an "Examination Glove" worn on the hand or finger to prevent contamination. Its function is a physical barrier, not an analysis of biological specimens.
- Intended Use: The intended use is to prevent contamination between patient and examiner, which is a barrier function, not a diagnostic one.
The information provided aligns with a Class I medical device (general controls) used for infection control, not an IVD.
N/A
Intended Use / Indications for Use
An Examination Gloves 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
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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol consists of three curved lines that form a shape reminiscent of a bird or a wave, with the bottom line having a more pronounced curve.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 NOV
Uniject Gloves Ltd. C/O Dr. Syed Z. Baber, Sr. International Suppliers, Incorporated P.O. Box 1035 Chalmette, Louisiana 70044
Re : K982611 Trade Name: Uniject Latex Examination Gloves (Powder-Free) Requlatory Class: I Product Code: LYY October 6, 1998 Dated: Received: October 7, 1998
Dear Dr. Baber:
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 Requlations, Title 21, Parts 800 to 895. ਕਿ 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 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 - Dr. Baber
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 ene regulation cheroids, "MEFR 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
Page - 2
INDICATIONS FOR USE
:
:
:
Applicant
3.0
UNIJECT GLOVES LTD. JEBEL ALL, DUBAI (U. A.E) 9826
510(K) Number (if known)
Device Name
UNIJECT EXAMINATION (H.UVES POWDER FREE
An Examination Gloves 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDKH Office of Device Evaluation (ODE) Prescription Use ............................................................................................................................................................. OR Over-The-Counter .. Per 21 CFR 801.109 (Division . Division of Denet, Infection Control, (Optional Format 1-2-96)
and General Hospital Devices and General Hospital Devices 510(k) Number
4.0 Glove Proprietary or Trade Name :
UNDECT EXAMINATION GLOVES