(105 days)
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)". It outlines the device's characteristics, indications for use, and a comparison to a predicate device, focusing on non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance.
The document provides multiple tables summarizing the performance and comparison of the proposed device to predicate devices. The primary table serving this purpose is "Table 3 Performance comparison" and the table that includes "Test Method," "Purpose," "Acceptance Criteria," and "Results" on Page 13.
| Test/Characteristic | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Before Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 500%, min | Tensile strength: 14MPa, min; Ultimate elongation: 500%, min (Implied "Pass" based on overall result) |
| After Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 400%, min | Tensile strength: 14MPa, min; Ultimate elongation: 400%, min (Implied "Pass" based on overall result) |
| Freedom from Holes (ASTM D5151-19) | No leakage at sampling level of G-1, AQL 2.5 | Pass |
| Residual Powder (ASTM D6124-06 (2022)) | 240 minutes, with specific, lower times for Carmustine (13.2 min) and Thiotepa (13.1 min). | The reported results in Table 4 (pages 10-11) match the acceptance criteria for each drug, indicating "Pass" or "Same". For Carmustine (13.2 min) and Thiotepa (13.1 min), the results are noted as "Similar" to the predicate, with explicit warnings not to use with these drugs due to low permeation times. |
| Biocompatibility | Irritation (ISO 10993-23): Not an irritant. | Under the conditions of the study, not an irritant. |
| Sensitization (ISO 10993-10): Not a sensitizer. | Under the conditions of the study, not a sensitizer. | |
| Acute Systemic Toxicity (ISO 10993-11): Device extract does not induce acute systemic toxicity reaction. | Under the conditions of the study, the device extract does not induce acute systemic toxicity response. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
The document does not specify the exact sample sizes used for each physical or chemical test. It references ASTM standards, which would typically define sampling plans. For instance, for Freedom from Holes, it mentions "sampling level of G-1, AQL 2.5," which refers to specific statistical sampling plans within ASTM D5151, but not the explicit number of gloves tested.
The data provenance is from non-clinical tests conducted to relevant ASTM and ISO standards. The Applicant, Shandong Xingyu Gloves Co., Ltd., is located in China, suggesting the tests were likely conducted there or by affiliated labs. The testing appears to be prospective as it was done specifically to evaluate the performance of this new device for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).
This document describes a device (gloves) and its performance under various physical and chemical stress tests, not imaging or diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the medical image interpretation sense (e.g., radiologists) is not applicable here. The "ground truth" for the performance claims (e.g., tensile strength, breakthrough time) is established by adherence to the specified and validated ASTM and ISO laboratory test methods and their defined measurement protocols. The experts involved would be the qualified laboratory technicians and chemists performing these standardized tests. Their qualifications are implicitly that they are capable of performing these standardized tests correctly.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving subjective human interpretation of data (e.g., medical images), where disagreements between readers need to be resolved by a third or fourth expert. Since this document describes non-clinical, objective laboratory testing of physical and chemical properties, an adjudication method as typically understood in a multi-reader clinical study is not applicable. The results are directly measured by instruments and adherence to test protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
No, an MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for medical gloves, based on non-clinical performance testing against established standards, not a diagnostic AI device requiring human reader interaction studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The "ground truth" for this device's performance claims is based on objective measurements obtained through standardized laboratory test methods (ASTM and ISO standards). For example:
- Physical properties (tensile strength, elongation): Measured in a lab according to ASTM D6319.
- Freedom from holes: Tested by inflation or water leak methods per ASTM D5151.
- Residual powder: Measured gravimetrically per ASTM D6124.
- Permeation by chemotherapy drugs/Fentanyl: Measured chromatographically by detecting breakthrough according to ASTM D6978.
- Biocompatibility: Evaluated in in vitro or in vivo models for specific biological endpoints (irritation, sensitization, systemic toxicity) following ISO 10993 standards.
The ground truth is therefore defined by the quantitative and qualitative results of these standardized, validated test procedures.
8. The sample size for the training set.
There is no training set mentioned or implied because this is not an AI/machine learning device. The device's performance is demonstrated through standard laboratory testing, not by training a model on a dataset.
9. How the ground truth for the training set was established.
As there is no training set, this question is not applicable.
§ 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.