(53 days)
Not Found
Not Found
No
The device description and intended use clearly describe a disposable medical glove, with no mention of AI or ML technology.
No
The device, a disposable glove, is intended to prevent contamination between patient and examiner, which is a preventive measure rather than a treatment or therapy for a medical condition.
No
The device is described as a medical glove intended to prevent contamination, not to diagnose any condition or disease.
No
The device description clearly states it is a physical glove, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between patient and examiner during medical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the glove (material, powder, protein content). There is no mention of any components or functions related to testing samples from the human body.
- Lack of IVD Indicators: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, this device is a medical glove intended for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Product codes
LYY
Device Description
PRE-POWDERED LATEX EXAMINATION GLOVES White color
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
Not Found
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.
0
Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
·Mr. Ngan Boon Seng Director STARMATRIX Sdn. Bhd. 10. Jalan SS 1/26. 47300 Petaling Jaya, Selangor, MALAYSIA
Re: K023977
Trade/Device Name: Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 26, 2002 Received: January 2, 2003
Dear Mr. Seng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Seng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Page of
510(k) Number (if known):_K023977
hite color
PRE-POWDERED LATEX EXAMINATION GLOVES Device Name: PROTEIN LABELING CLAIM ( 100 Mg of less
Indications For Use THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP 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 PAGI NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chiu S. Lim
(Division Sign-Off)
Division of Anesthesiology, General Hospital. Infection Control, Dental Devic
510(k) Number: K023927
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use
(Optional Formal 1