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510(k) Data Aggregation
(51 days)
This glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
This document is a 510(k) premarket notification letter from the FDA to APL Products Sdn. Bhd. for their "Online Powder Free, Latex Examination Gloves". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a premarket approval application (PMA). Substantial equivalence is generally based on demonstrating the new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics and performance data to that of the predicate, but the specific acceptance criteria and detailed study results are not provided in this document.
Therefore, I cannot provide the requested information based on the provided text.
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(62 days)
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(47 days)
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
POWDER FREE, LATEX EXAMINATION GLOVES - Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" and an "Indications for Use Statement".
It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the nature of a test set.
- Information on experts, ground truth establishment, or adjudication methods.
- Data on multi-reader multi-case studies or standalone algorithm performance.
- Information about training sets or how their ground truth was established.
The document is purely an FDA clearance confirmation and related administrative information.
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