(344 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Aloe Vera: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, and Vincristine Sulfate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.
Non-Sterile, Powder Free Nitrile Examination Gloves: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, Vincristine Sulfate, and Fentanyl Citrate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.
The provided text is related to a 510(k) premarket notification for nitrile examination gloves and does not contain information about the acceptance criteria or a study that typically involves AI/ML device performance. Instead, it details the indications for use and the gloves' resistance to permeation by chemotherapy drugs and fentanyl citrate, in accordance with ASTM D6978.
Therefore, I cannot extract the information required to answer your questions as they pertain to AI/ML device performance studies and acceptance criteria. The document focuses on regulatory clearance for medical gloves based on chemical resistance testing, not on an AI/ML algorithm's performance.
§ 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.