(133 days)
Not Found
Not Found
No
The summary describes a standard medical glove and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No
Explanation: The device is a medical glove intended to prevent contamination, not to diagnose, treat, or prevent a disease or condition for therapeutic purposes.
No
Explanation: The device, a Medical glove, is described as preventing contamination. Its intended use does not involve obtaining, processing, or analyzing medical data to diagnose a condition, which are characteristics of a diagnostic device.
No
The device description clearly states it is a "Powder Free Latex Patient Examination Glove," which is a physical hardware device, not software.
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 healthcare personnel and patients by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Powder Free Latex Patient Examination Gloves." This is 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 used to perform tests in vitro (outside the body) on samples to gain information about a person's health status. Medical gloves are a physical barrier used in vivo (on the body) to prevent the spread of contamination.
N/A
Intended Use / Indications for Use
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Product codes
LYY
Device Description
Powder Free Latex Patient Examination Gloves
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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/2 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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. A. Hendra Ramali ·President Director P.T. Latexindo Tobaperkasa Jalan Raya Binjai Km. 11 Medan 20128, Indonesia
NOV 1 8 1997
K972539 Re : Trade Name: Hi Coat Powder-Free Latex Patient Examination Gloves Requlatory Class: I Product Code: LYY Dated: October 28, 1997 Received: November 3, 1997
Dear Ms. Ramali:
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 abe Beaced in the eny 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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 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
1
Page 2 - Ms. Ramali
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 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,
K. Aldrich
Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
. 5
2
Image /page/2/Picture/0 description: The image shows the text "P.T. LATEXINDO TOBAPERKASA" in a bold, outlined font. The text is arranged horizontally, with each word clearly separated. A thin line is present underneath the text, adding a subtle emphasis to the words above.
Jalan Raya Binjai Km. 11, Medan - Indonesia, Phone/Fax. : (62 - 61) 851410gtf8fffffent 1
Indication For Use Statement
912539 510(K) Number (if known) : Device Name : Powder Free Latex Patient Examination Gloves Indication For Use : A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. PT. Latexindo Tobaperkasa Hendra Ramali President Director (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Division of Dental, Infection Control, Cicci and General Hospital Defencurrence of CDRH, Office of Device Evaluation (ODE 510/k) Number __ - 60 97753 Over-The-Counter Use Prescription Use Or (Per 21 CFR 801.109)
(Optimal Format 1-2-96)