(28 days)
Not Found
Not Found
No
The device is a medical glove, and the summary describes its material and intended use for barrier protection, with no mention of AI or ML capabilities.
No
The device, a medical glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: This device is described as a "Blue Powder-Free Nitrile Examination Glove" intended to prevent contamination. It does not perform any diagnostic function.
No
The device described is a physical medical glove, not a software-only medical device. The description clearly states it is a "blue powder-free medical glove made from synthetic nitrile latex" and "Blue Powder-Free Nitrile Examination Gloves." There is no mention of software functionality.
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 the patient's body, fluid, waste, or environment. This is a barrier function, not a diagnostic function performed in vitro (outside the living body).
- Device Description: The device is a medical glove. Gloves are physical barriers, not diagnostic tools.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status.
- No Mention of IVD-Related Terms: The description does not include any terms typically associated with IVDs, such as "assay," "reagent," "sample analysis," "diagnostic test," etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A blue powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
Product codes
LZA
Device Description
Blue Powder-Free Nitrile Examination Gloves
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
hand
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1999
Mr. Heng Cheng Hui Managing Director Masju Sdn. Bhd. Plot 3, Jalan 1, Tikam Batu Industrial Estate, 08600 Sungai Petani, Kedah MALAYSIA
Re : K991493 Blue Powder-Free Nitrile Examination Gloves Trade Name: Requlatory Class: I Product Code: LZA April 22, 1999 Dated: April 28, 1999 Received:
Dear Mr. Hui:
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 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 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Mr. Hui
this response to your premarket notification Please note: 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 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" (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,
Susan Punner
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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page The information, data and labeling claims in the entire the 510(k) submission must support anc agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | MASJU SDN. BHD. |
|---|---|
| 510(k) Number (if known): * | K 991493 |
| Device Name: | Blue Powder-Free Nitrile Examination Gloves |
| Indications For Use: |
A blue powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)
Over-The-Counter X
- For a new submission, do NOT fill in the 510(k) number blank.
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .