(151 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
The provided text is a 510(k) premarket notification for patient examination gloves, specifically focusing on their resistance to chemotherapy drugs. The study described is a chemical permeation test, not a study involving AI, human readers, or medical imaging. Therefore, many of the requested criteria (like ground truth establishment with experts, MRMC studies, or training set details) are not applicable to this type of device and study.
However, I can extract the acceptance criteria and the device's performance based on the provided tables.
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves regarding chemotherapy drug permeation is established by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The "Minimum Breakthrough Detection Time" listed in the table represents the device's performance against each specified drug. Implicitly, for the device to be considered acceptable, the breakthrough time must meet or exceed a certain, unstated, threshold relative to the expected duration of risk or exposure. For most drugs, a breakthrough time of ">240 minutes" indicates high resistance. However, the manufacturer notes that Carmustine (BCNU) and Thiotepa show significantly lower breakthrough times, indicating they are aware of and disclosing these specific limitations against their acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance (Blue Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05, no specific numerical threshold provided here for individual drugs beyond the general standard. | 10.2 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves is identical, based on ASTM D6978-05 (Reapproved 2013).
Table of Acceptance Criteria and Reported Device Performance (White Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05 | 10.1 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Since this is a report for medical gloves and not an AI/imaging device, the following points are not applicable (N/A) based on the provided text:
- Sample size used for the test set and the data provenance: The document does not specify the number of gloves tested for each drug, only the minimum breakthrough detection time. Data provenance refers to the origin of the materials or testing, which would presumably be the manufacturer's testing facilities (Kossan International Sdn. Bhd. in Malaysia). This is a measurement of physical properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for chemical permeation is established by direct measurement using specified laboratory methods (ASTM D6978-05). It does not require human expert consensus or interpretation in the way AI or imaging studies do.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. Adjudication is for human interpretation of data, not physical property testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A. This is a framework for comparing human reader performance, typically with and without AI assistance in medical imaging.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. The device is a physical glove, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is the measured breakthrough time as determined by the ASTM D6978-05 standard, which describes the specific laboratory methodology to assess permeation.
- The sample size for the training set: N/A. There is no concept of a "training set" for physical product testing via a standardized method like ASTM D6978-05.
- How the ground truth for the training set was established: N/A.
§ 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.