(199 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
The provided text is a 510(k) summary for Disposable Powder Free Nitrile Examination Gloves, white and blue colors, tested for use with chemotherapy drugs. It focuses on the safety and effectiveness of the device through non-clinical testing and comparison to a predicate device.
Here's an analysis to extract the requested information, noting that much of it pertains to AI/software device studies and is not applicable to this type of medical glove submission:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance (White Gloves) | Reported Device Performance (Blue Gloves) |
|---|---|---|---|
| Chemotherapy Drug Permeation | ASTM D6978-05 Minimum Breakthrough Detection Time (Min) | ||
| Carmustine (BCNU), 3.3 mg/ml | - (No specific minimum listed, but tested) | 22.8 minutes | 6.2 minutes |
| Thiotepa, 10.0 mg/ml | - (No specific minimum listed, but tested) | 54.6 minutes | 38.8 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Cisplatin, 1.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Fluorouracil, 50.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 minutes (Maximum testing time) | ≥ 240 minutes | ≥ 240 minutes |
| Dimension | ASTM D6319-10(Reapproved 2015) | Complies | Complies |
| Length | ≥ 230mm | Complies (230 mm min) | Complies (230 mm min) |
| Width (Small) | 80 ±10 mm | Complies (80 ±10 mm) | Complies (80 ±10 mm) |
| Width (Medium) | 95 ±10 mm | Complies (95 ±10 mm) | Complies (95 ±10 mm) |
| Width (Large) | 110 ±10 mm | Complies (110 ±10 mm) | Complies (110 ±10 mm) |
| Width (X-Large) | 120 ±10 mm | Complies (120 ±10 mm) | Complies (120 ±10 mm) |
| Thickness (Finger tip) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Thickness (Palm) | ≥ 0.05mm | Complies (≥ 0.05mm) | Complies (≥ 0.05mm) |
| Physical Properties | ASTM D6319-10(Reapproved 2015) | ||
| Tensile strength (Before aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Tensile strength (After aging) | ≥ 14MPa | Complies (≥ 14MPa) | Complies (≥ 14MPa) |
| Elongation (Before aging) | ≥ 500% | Complies (≥ 500%) | Complies (≥ 500%) |
| Elongation (After aging) | ≥ 400% | Complies (≥ 400%) | Complies (≥ 400%) |
| Freedom from pinholes | 21 CFR 800.20 and ASTM D6319-10 (Water leak test) | Passed | Passed |
| Powder Residual | ASTM D6319-10 (Test method D5151-06, D6124-06) Acceptance Criteria: |
§ 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.