(103 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 is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate
Warning: Not Recommended For Use With Carmustine and Thio-Tepa
Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.
This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically Powder Free Nitrile Examination Gloves. The letter states that the device has been found substantially equivalent to legally marketed predicate devices.
However, this type of regulatory document does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.
Here's why and what kind of information you would typically need:
- Acceptance Criteria & Device Performance: This letter only states "substantial equivalence." It does not list specific performance metrics (e.g., tensile strength, barrier integrity, chemotherapy drug permeation resistance levels) or the results of tests against predefined criteria. Such information would be in the 510(k) submission itself, specifically in the performance data section.
- Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all details pertaining to a clinical study or rigorous performance testing study. The 510(k) letter is a regulatory approval, not the study report. For medical gloves, the "study" is usually a series of bench tests (e.g., ASTM standards for physical properties, chemotherapy permeation tests).
To answer your questions, I would need access to the actual 510(k) submission document, particularly the sections detailing the performance data and testing methods.
What I can infer from the provided text is:
- Device Name: Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.
- Indications for Use: "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." And "This glove is tested for use with [list of 12 chemotherapy drugs, with warnings against Carmustine and Thio-Tepa]."
- Regulatory Status: Class I medical device (21 CFR 880.6250 - Patient Examination Glove).
- 510(k) Number: K090412
Without the actual testing data from the 510(k) submission, listing acceptance criteria and device performance is not possible from this document.
§ 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.