Search Results
Found 5 results
510(k) Data Aggregation
(30 days)
Ask a specific question about this device
(48 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
The provided text is a 510(k) clearance letter from the FDA for "HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)". This document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the information required to answer your specific questions about acceptance criteria and the study that proves the device meets the acceptance criteria is not present in the provided document.
This 510(k) letter is a regulatory approval document and typically summarizes the FDA's decision based on information provided in the 510(k) submission. It does not elaborate on the specific test methods, sample sizes, ground truth establishment, or detailed study results that were part of that submission.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance: This detailed data is not in the approval letter.
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: Not specified.
- If a standalone study (algorithm only without human-in-the-loop performance) was done: Not specified (this device is a physical glove, not an algorithm, so this question is not applicable in its current form).
- The type of ground truth used: Not specified.
- The sample size for the training set: Not specified (not applicable for this type of device).
- How the ground truth for the training set was established: Not specified (not applicable for this type of device).
To obtain this information, one would typically need to review the full 510(k) submission document, which would include the detailed testing protocols and results that led to the FDA's substantial equivalence determination.
Ask a specific question about this device
(38 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Latex Examination Glove
This document is a 510(k) clearance letter from the FDA for a medical device: "HWA (and)Silktex Powder-Free Latex Examination Glove". It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information (device performance metrics, study design, ground truth establishment, sample sizes, etc.) is typically found in the accompanying 510(k) summary or detailed submission, not in the clearance letter itself.
Therefore, I cannot provide the requested information based solely on the text provided. The document confirms market clearance but does not detail the technical performance characteristics or the studies behind them.
Ask a specific question about this device
(32 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
HWA and Silktex Powdered Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for examination gloves. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices or AI algorithms. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance.
Therefore, I cannot provide the requested information. The document does not describe the specific acceptance criteria or a study with performance metrics, sample sizes, expert qualifications, or ground truth details. The FDA's determination of substantial equivalence for these types of devices is usually based on adherence to recognized standards and successful prior registrations, rather than a detailed performance study as would be required for novel or high-risk devices/algorithms.
Ask a specific question about this device
(88 days)
Ask a specific question about this device
Page 1 of 1