(89 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 device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue); Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
This document describes the 510(k) premarket notification for Powder Free Nitrile Examination Gloves (6Mil) and Sterile, Powder Free Nitrile Examination Gloves, both tested for use with chemotherapy drugs (Blue). The key information revolves around the gloves' resistance to permeation by specific chemotherapy drugs.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a single numerical threshold for each drug, but rather presents the average breakthrough detection time for each chemotherapy drug. The implication is that a longer breakthrough time is better, with "> 240 minutes" being the best reported performance for many drugs, suggesting that a 240-minute duration without breakthrough is considered acceptable for practical use. The specific performance for some drugs which are noted as having "extremely low permeation time" for the Sterile glove indicates they do not meet a high standard of protection for those particular drugs.
| Chemo Drug (Concentration) | Acceptance Criteria (Implied) | Powder Free Nitrile (6mil) Performance (Average Breakthrough Time in Minutes) | Sterile, Powder Free Nitrile Performance (Average Breakthrough Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) (3.3 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 111.9 | 0.51 (Noted as "extremely low") |
| Thiotepa (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 162.3 | 36.5 (Noted as "extremely low") |
| Fluorouracil (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitomycin C (0.5 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Methotrexate (25.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cisplatin (1.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitoxantrone (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Ifosfamide (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Vincristine Sulfate (1.0mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
The acceptance criteria for glove performance against chemotherapy drugs generally follow standards like ASTM D6978, which specifies a minimum breakthrough time. While not explicitly stated as "acceptance criteria," the consistent reporting of "> 240 minutes" for many drugs suggests that 240 minutes is the target threshold for extended protection. The note concerning Carmustine and Thiotepa for the Sterile gloves indicates that their performance of
§ 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.