(95 days)
The Nittile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table.
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Druzs (Blue)
This document is a 510(k) premarket notification for a medical glove, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance is not applicable.
The document discusses the device's substantial equivalence to a predicate device and its indications for use, specifically for protecting against contamination and certain chemotherapy drugs.
Here's the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of device performance metrics often associated with AI/ML. Instead, it provides breakthrough times for the glove's resistance to various chemotherapy drugs. This can be interpreted as the device's performance regarding chemical impermeability.
| Chemotherapy Drug (Concentration) | Reported Breakthrough Time |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 minutes |
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 | > 240 minutes |
| mg/ml) | |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 | > 240 minutes |
| mg/ml) | |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 20.3 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
2-9. Other Requested Information (Sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth type, training set details)
This information is not applicable to this document as it pertains to a traditional medical device (examination glove) and not an AI/ML powered device. The document does not describe any studies involving algorithms, data sets, human readers, or expert consensus for AI/ML performance evaluation.
§ 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.