(342 days)
A powder free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Cisplatin, 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 |
| Carmustine (BCNU), 3.3mg/ml | 1.0 |
| Dacarbazine (DTIC), 10.0mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml | >240 |
| Etoposide (Toposar), 20.0mg/ml | >240 |
| Fluorouracil, 50.0mg/ml | >240 |
| Paclitaxel (Taxol), 6.0mg/ml | >240 |
| Thiotepa, 10.0mg/ml | 31.3 |
| Methotrexate ,25mg/ml | >240 |
| Mitomycin C, 0.5mg/ml | >240 |
| Vincristine Sulfate, 1.0mg/ml | >240 |
| Ifosfamide, 50.0mg/ml | >240 |
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
This document does not describe a device that uses Artificial Intelligence (AI) or Machine Learning (ML). It is an FDA 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML device is not applicable to this document.
The document focuses on the physical and chemical properties of the gloves, primarily their resistance to permeation by chemotherapy drugs, and compares them to established ASTM standards and a predicate device.
However, to address the acceptance criteria and performance data as presented in the document for the physical device (gloves):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are primarily based on ASTM standards. The relevant performance data is provided in "Table 1" on page 4 of the document, comparing the applicant's device to a predicate device and relevant standards.
| Characteristics | Standards | Acceptance Criteria (from Standards or Predicate) | Reported Device Performance (Current Device) |
|---|---|---|---|
| Dimensions | ASTM D6319-10 | Min 240mm (Predicate) | Min 270mm |
| Physical Properties | ASTM D6319-10 | Meet | Meet |
| Thickness - Finger | ASTM D6319-10 | 0.07-0.10mm (Predicate) | Min 0.10mm |
| Thickness - Palm | ASTM D6319-10 | 0.07-0.09mm (Predicate) | Min 0.10mm |
| Freedom From Holes | ASTM D6319-10 and ASTM D5151 | Pass | Pass |
| Powder Free Residue | ASTM D6319-10 and ASTM D6124 | Meet | Meet |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | Minimum Breakthrough Detection Time (min) | Minimum Breakthrough Detection Time (min) | |
| Cisplatin, 1.0mg/ml | >240 minutes | >240 minutes | |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 minutes | >240 minutes | |
| Carmustine (BCNU), 3.3mg/ml | 15.0 minutes | 1.0 minute (with warning) | |
| Dacarbazine (DTIC), 10.0mg/ml | >240 minutes | >240 minutes | |
| Etoposide (Toposar), 20.0mg/ml | >240 minutes | >240 minutes | |
| Doxorubicin Hydrochloride, 2.0mg/ml | >240 minutes | >240 minutes | |
| Fluorouracil, 50.0mg/ml | >240 minutes | >240 minutes | |
| Paclitaxel (Taxol), 6.0mg/ml | >240 minutes | >240 minutes | |
| Thiotepa, 10.0mg/ml | 2.0 minutes | 31.3 minutes (with warning) | |
| Methotrexate, 25mg/ml | - (Not explicitly listed for predicate) | >240 minutes | |
| Mitomycin C, 0.5mg/ml | - (Not explicitly listed for predicate) | >240 minutes | |
| Vincristine Sulfate, 1.0mg/ml | >240 minutes | >240 minutes | |
| Ifosfamide, 50.0mg/ml | >240 minutes | >240 minutes | |
| Biocompatibility - Primary Skin Irritation | ISO 10993 | Pass | Pass |
| Biocompatibility - Dermal Sensitization | ISO 10993 | Pass | Pass |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Texture | - | Finger Textured | Finger Textured |
Note on Chemotherapy Drug Permeation: The "acceptance criteria" here are comparison points from the predicate device and the standard. The device performance for Carmustine and Thiotepa for the current device are lower than >240 minutes, but still considered acceptable with explicit warnings regarding their low permeation times, similar to how the predicate device also had drugs with low permeation times. For Thiotepa, the current device performance (31.3 minutes) is significantly better than the predicate (2.0 minutes). For Carmustine, the current device performance (1.0 minute) is lower than the predicate (15.0 minutes). These differences are noted and addressed by a warning statement.
This summary is based on the information provided, which details the device's compliance with established industry standards for patient examination gloves and specific testing for chemotherapy drug permeation.
§ 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.