(36 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.
Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Basic Non-Sterile, Powder-Free Latex Examination Gloves
This is a challenging request as the provided text is a medical device clearance letter from the FDA (K991849), not a scientific study or a performance report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document grants clearance for a device based on substantial equivalence to a predicate device, not on meeting specific, quantifiable performance metrics through a new study as you've outlined.
Here's a breakdown of why I cannot fulfill the request with the given input and what information is present:
Information NOT present in the document:
- A table of acceptance criteria and the reported device performance: This document doesn't define or report on specific performance criteria (e.g., sensitivity, specificity, accuracy) for the new device. Its clearance is based on comparison to an existing device.
- Sample sized used for the test set and the data provenance: No new testing data is presented.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable, as no new study with ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is a physical glove, not an algorithm).
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: "Non-Sterile, Power-Free Latex Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extractable Protein)" and trade names "Cashmere Non-Sterile, Powder-Free Latex Examination Gloves" and "Basic Non-Sterile, Powder-Free Latex Examination Gloves."
- Indications For Use: "This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment."
- Regulatory Class: Class I
- Product Code: LYY
- Key claim: "50 Micrograms or Less Total Water Extractable Protein" (This is a specific characteristic, but not a performance metric like sensitivity or specificity).
- Regulatory Mechanism: 510(k) clearance based on substantial equivalence to predicate devices marketed before May 28, 1976. This explicitly states that the device is considered equivalent, not that it has passed a new, detailed performance study with quantifiable criteria.
In summary: The provided FDA letter is a regulatory approval document and does not contain the detailed study results and acceptance criteria typically found in a scientific paper or a device's performance validation report. Therefore, I cannot extract the requested information from this text.
§ 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.