(113 days)
Not Found
Not Found
No
The summary describes a standard examination glove with no mention of AI or ML capabilities.
No
The device, a medical examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is an examination glove, which is used for contamination prevention during medical examinations, not for diagnosing conditions.
No
The device is a physical glove, not software. The description clearly states it is a "Powder Free Latex Examination Glove".
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: The device is a glove, which is a physical barrier.
- 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
LYY
Device Description
UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle, with three wavy lines representing its body and wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 1999
Ms. Tarani Devi Exe. Director American HealthCare Products (M) Sdn. Bhd. No. 39, Jalan Rebena 3, Off Jalan Seruling 59, Taman Klang Jaya 41200 Klang, Selangor Darul Ehsan, MALAYSIA
Re : K983614 Uniseal Powder-Free Latex Examination Gloves Trade Name: (Blue & Green Colored) Regulatory Class: I Product Code: LYY Dated: January 7, 1999 Received: January 13, 1999
Dear Ms. Devi:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 requirements, as set forth in the Quality System Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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
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Page 2 - Ms. Devi
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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" (21CFR 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/dsma/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
INDICATIONS FOR USE STATEMENT
| 510(K) Number | K983614 |
|---|---|
| Device Name | UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN) |
Indication for use :
י געולים מתוך שלו צינוד צמרי
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)
Prescription Use (Per 21 CFR 801.109) OR
Over - The-Counter Use (Optical Format 1-2-96)
Clim S. Lim
(Division Sign-Off) ( Division of Dental, Infection Control, and General of Demal, Intection
and General Hospital Devices 510(k) Number _
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