(189 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.
The provided document is a 510(k) premarket notification decision letter for Sterile, Powder Free Nitrile Examination Gloves, Blue, tested for use with chemotherapy drugs. It does not describe an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies for such devices cannot be extracted.
The document discusses the substantial equivalence determination for nitrile examination gloves to legally marketed predicate devices. The "Indications for Use" section lists specific chemotherapy drugs and their respective permeation (breakthrough detection) times when tested with the gloves.
Information that CAN be extracted, reorganized from the "Indications for Use" section:
1. A table of specific performance data (permeation times) for the device:
| Chemotherapy Drug | Concentration | Permeation (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Dacarbazine (DTIC) | 10.0 mg/mL | > 240 |
| Mitomycin C | 5.0 mg/mL | > 240 |
| Carmustine (BCNU) | 3.3 mg/mL | 3.57 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL | > 240 |
| 5-Fluorouracil | 50.0 mg/mL | > 240 |
| Cisplatin | 1.0 mg/mL | > 240 |
| Etoposide | 20.0 mg/mL | > 240 |
| Paclitaxel (Taxol) | 6.0 mg/mL | > 240 |
| Thio-Tepa | 10.0 mg/mL | 24.39 |
| Vincristine Sulfate | 50.0 mg/mL | > 240 |
| Methotrexate | 25.0 mg/mL | > 240 |
| Mitoxantrone | 100.0 mg/mL | > 240 |
| Ifosfamide (Ifex) | 50.0 mg/mL | > 240 |
| Warning on Labeling: Do Not Use with Thiotepa and Carmustine |
Note: The document does not explicitly state the "acceptance criteria" as a single defined threshold for all drugs, but rather presents the measured performance against a listed set of chemotherapy drugs. The determination of "substantial equivalence" implies that the observed permeation times are considered acceptable compared to predicate devices for the indicated use. The warnings for Thiotepa and Carmustine indicate that the performance for these drugs was deemed insufficient for safe use, despite having measured breakthrough times.
The following information cannot be extracted from the provided text as it pertains to AI/ML device studies, which is not the subject of this document:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set 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.