(123 days)
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
This document is a 510(k) clearance letter from the FDA for a new medical device, specifically examination gloves. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable.
However, I can extract the relevant "acceptance criteria" for the gloves in terms of their resistance to chemotherapy drugs and other solutions, as presented in the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves are implicitly defined by their performance against the listed chemicals, demonstrating their barrier effectiveness by reporting breakthrough times according to ASTM D6978-05 (2019). The goal is to show a reasonably long breakthrough time for protection. While specific pass/fail thresholds are not explicitly stated as "acceptance criteria" in a quantitative sense here, the reported times indicate the device's protective capabilities.
| Chemotherapy Drug and Concentration | Black Color (Reported Performance - Breakthrough Time) | Gray Color (Reported Performance - Breakthrough Time) |
|---|---|---|
| Carmustine (BCNU), 3.3mg/ml | 84.3 mins | 54 mins |
| Cisplatin, 1.0mg/ml | >240 mins | >240 mins |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 mins | >240 mins |
| Dacarbazine (DTIC), 10mg/ml | >240 mins | >240 mins |
| Doxorubicin Hydrochloride, 2.0mg/ml | >240 mins | >240 mins |
| Etoposide (Toposar), 20mg/ml | >240 mins | >240 mins |
| Fluorouracil, 50mg/ml | >240 mins | >240 mins |
| Paclitaxel (Taxol), 6.0mg/ml | >240 mins | >240 mins |
| Thiotepa, 10mg/ml | 116.2 mins | 109.4 mins |
| Fentanyl Citrate, 100mcg/2ml | >240 mins | >240 mins |
| Simulated Gastric Acid | >240 mins | >240 mins |
| Fentanyl-Simulated Gastric Acid Solution 50/50 | >240 mins | >240 mins |
Note: The document explicitly highlights lower breakthrough times for Carmustine and Thiotepa as a "CAUTION," indicating these values are notable and potentially below a desired threshold, though a hard "failure" isn't stated for regulatory clearance.
The rest of the requested information (points 2-9) is not applicable to this document because it describes a physical medical device (examination gloves), not an AI/ML-powered software. Therefore, there is no mention of:
- Sample size used for an AI test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (beyond chemical testing results).
- Training set size or how its ground truth was established.
§ 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.