(54 days)
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No
The 510(k) summary describes a standard medical glove with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, not to treat a disease or condition.
No
Explanation: The device is described as a medical glove, intended to prevent contamination. There is no information suggesting it is used to identify or diagnose a disease or condition.
No
The device is described as a "medical glove" and "Powder-Free Latex Examination Gloves," which are physical hardware components, not software.
No, 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 by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status.
- No Mention of IVD-Related Terms: The description doesn't include terms commonly associated with IVDs like "assay," "reagent," "analyzer," "diagnostic," or "test."
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
This medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Product codes
IYY
Device Description
Powder-Free Latex 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY #1 4 1999
Mr. Pack Loon Tang QA Manager AMPRI RUBBER INDUSTRIES SDN. BHD. Lot B5 & B6, Phase II Kawasan Perindustrian Miel, Batang Kali Phase II 44300 Batang Kali, Selangor, MALAYSIA
Re : K990812 Powder-Free Latex Examination Glove with Trade Name: Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: IYY Dated: April 12, 1999 Received: April 15, 1999
Dear Mr. Pack Loon Tang
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, qood 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. ਕੇ 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 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 through 542 of
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Page 2 - Mr. Pack Loon Tang
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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant: AMPri Rubberware Industries Sdn Bhd 510(k) Number (if known): * Device Name: Powder-Free Latex Examination Gloves Indications for Use:
Contains 50 mcgm OR less of Total Wo expractable profe - goar
This medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Cocurrence of CDRH Officeof 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.
Qiu S. Lin
(Division Sign-Off)
Division of Dentril, Infection Control, and General Mospitel D. 510(k) Number .