(53 days)
Not Found
Not Found
No
The device is a medical glove, and the summary contains no mention of AI, ML, or any related technologies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a glove worn by healthcare personnel to prevent contamination, which is a preventive measure, not a treatment.
No
Explanation: The device, a medical glove, is intended to prevent contamination between healthcare personnel and the patient. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical medical glove, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the medical glove is to prevent contamination between healthcare personnel and the patient. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics of the glove (powder-free, latex, protein labeling). There is no mention of any components or functions related to testing samples or providing diagnostic information.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key elements typically associated with IVDs, such as:
- Image processing
- AI, DNN, or ML
- Input Imaging Modality
- Description of training/test sets and performance studies (which are crucial for validating the accuracy of a diagnostic device).
- Key Metrics (Sensitivity, Specificity, etc.)
IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. A medical glove does not perform this function.
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 the patient.
Product codes
LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Tekmedic (M) Sdn. Bhd. c/o Mr. Kok-Kee Hon Official Correspondent Tekmedic (M) Sdn. Bhd. 6324 Meeting House Way Alexandria, VA 22312-1718
K994250 Re: Tekmedic Powder-Free Latex Examination Trade Name: Gloves With Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: I LYY Product Code: Dated: December 14, 1999 December 16, 1999 Received:
Dear Mr. Hon:
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 regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Mr. Hon
Please note: this response to your the Federal Register. 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.
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,
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 is a black and white logo for "tekmedic". The logo is a circle with horizontal lines at the top, the word "tekmedic" in the middle, and a solid black section at the bottom. The word "tekmedic" is in a sans-serif font.
Appendix 2
INDICATIONS FOR USE
Applicant: Tekmedic (M) Sdn. Bhd.
510 (k) Number (if known): K 99 42 50
Device Name: Tekmedic Powder-Free Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less)
Indications For Use:
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
| Chin S. Lin | Prescription Use -------- |
|---|---|
| Per 21 CFR 801.109 | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices |
$10(k) Number
OR
Over-The-Counter X