(82 days)
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
Cisplatin 1.0 mg/ml >= 240
Cyclophosphamide (Cytoxan) 20 mg/ml >= 240
Dacarbazine (DTIC) 10.0 mg/ml >= 240
Doxorubicin Hydrochloride 2.0 mg/ml >= 240
Etoposide (Toposar) 20.0 mg/ml >= 240
Fluorouracil 50.0 mg/ml >= 240
Paclitaxel (Taxol) 6.0 mg/ml >= 240
*Carmustine (BCNU) 3.3mg.ml 54.1 (minutes)
*Thiotepa 10.0 mg/ml 6.0 (minutes)
*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.
Tested Fentanyl Citrate is as follows: Fentanyl Citrate Injection 100.0 mcg/2ml Average Breakthrough Detection Time (minutes) >= 240
Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the premarket notification (510(k)) for Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. This is a medical device, and the acceptance criteria and study proving it meets these criteria are based on non-clinical performance standards rather than an AI/human reader study.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally defined by adherence to specific ASTM and ISO standards for examination gloves. The reported device performance is presented in several tables.
| Characteristics / Test | Standard / Reference Test Method & Sampling | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Glove Specifications | ASTM D6319-10(2015) | ||
| Palm width (XS) | 75 ± 5 mm | Not explicitly stated for the final product, but implied to meet this standard | |
| Palm width (S) | 85 ± 5 mm | ||
| Palm width (M) | 95 ± 5 mm | ||
| Palm width (L) | 105 ± 5 mm | ||
| Palm width (XL) | 115 ± 5 mm | ||
| Length | Min 240 mm | Min 240 mm (Table 6) | |
| Thickness (Palm/Finger) | Min 0.05 mm | Min 0.05 mm (Table 6) | |
| Physical Properties | Meets (ASTM D6319-10(2015)) | Meets (Table 2) | |
| Powder Content | ASTM D6124-06(2011) | Meets (ASTM D6124-06(2011)) | Meets / 0.50 mg/glove (Table 2, Table 6) |
| Chemotherapy Drugs Permeation | ASTM D6978-2005 (Reapproved 2019) | Minimum Breakthrough Detection Time (minutes) | Minimum Breakthrough Detection Time (minutes) - Device Performance |
| Cisplatin 1.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Fluorouracil 50.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 | ≥ 240 (Table 3, Table 7) | |
| Carmustine (BCNU) 3.3 mg/ml | No explicit threshold given in acceptance criteria, but predicate had 10.1 min | 54.1 (Table 3, Table 7), with caution statement | |
| Thiotepa 10.0 mg/ml | No explicit threshold given in acceptance criteria, but predicate had 30.2 min | 16.0 (Table 3, Table 7), with warning statement | |
| Fentanyl Citrate Permeation | ASTM D6978-2005 (Reapproved 2019) | ||
| Fentanyl Citrate Injection 100.0 mcg/2ml | ≥ 240 | ≥ 240 (Table 3, Table 8) | |
| Biocompatibility | ISO 10993-10: 2010 (Irritation & Sensitization) | Non-irritating and non-sensitization | Non-irritating and non-sensitization (Table 2) |
| ISO 10993-5: 2009 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic (Table 2) | |
| Watertight | 21 CFR 800.20, ASTM D5151 | Passes | Passes (Table 2) |
| Dimension (QA Test) | ASTM D6319-10(2015), ANSI/ASQC 21.4-2003 | Meet Acceptance Number (AQL 4.0, S-2) | Implied by "Meet Acceptance Number" column in Table 3 |
| Tensile strength & Ultimate elongation (QA Test) | ASTM D6319-10(2015), ANSI/ASQC 21.4-2003 | Meet Acceptance Number (AQL 4.0, S-2) | Pass (Minimum 16.44 MPa for Tensile Strength, Minimum 427% for Ultimate Elongation) (Table 5) |
| Water Leak (QA Test) | FDA 1000ml water leak test method (21CFR 800.20), ANSI/ASQC 21.4-2003 | Meet Acceptance Number (AQL 1.5, G-1) | Pass (No. Of Defective = 0 for Freedom From Holes, tested separately) (Table 5) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes:
- Physical Property Tests (Tensile Strength, Elongation): 13 samples (Table 4, Table 5)
- Freedom From Holes: 80 samples/batch (Table 5)
- Powder Residual Test: 1 sample (Table 6)
- Chemotherapy and Fentanyl Permeation Tests: 3 specimens per drug (e.g., Specimen 1/2/3 in Table 7 and 8)
- Quality Assurance Testing: Batch inspection levels (S-2 for Dimension/Tensile, G-1 for Water Leak). The AQL (Acceptable Quality Level) values (4.0 or 1.5) and inspection levels indicate a sampling plan from production lots, not a fixed pre-defined test set.
- Data Provenance: The document does not explicitly state the country of origin of the test data or whether the studies were retrospective or prospective. Given the submitter (Comfort Rubber Gloves Industries Sdn. Bhd.) is located in Malaysia, it is highly probable that the testing was conducted in Malaysia or a recognized testing facility accessible to them. The tests are non-clinical (laboratory/material tests), so the "prospective/retrospective" distinction isn't typically applied as it would be for a clinical study with human subjects.
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 device is a physical medical glove and the acceptance criteria are based on objective, quantifiable physical and chemical properties measured according to established international standards (ASTM, ISO, FDA methods). Therefore, the "ground truth" is established by these laboratory tests and their measurement results, not by expert consensus or interpretation as would be the case for diagnostic imaging AI. No interpretation by medical experts (like radiologists) is relevant for establishing the "ground truth" for glove performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI/diagnostic device that relies on human interpretation or adjudication for its "ground truth." The tests are laboratory-based with objective metrics.
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
Not applicable. This is a physical medical device (examination gloves), not a diagnostic AI system or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The performance evaluation is solely based on its physical and chemical properties as measured in a lab, which is "standalone" in the sense that no human-in-the-loop interaction is required for the device's function or evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Adherence to Established Standards: ASTM (American Society for Testing and Materials) standards for physical properties of medical gloves (e.g., D6319 for dimensions, tensile strength, elongation; D6124 for powder residue; D5151 for holes), and D6978 for chemotherapy drug permeation.
- International Organization for Standardization (ISO) Standards: ISO 10993 for biocompatibility (irritation, sensitization, cytotoxicity).
- FDA Test Methods: Specifically, the FDA 1000ml water leak test method (21 CFR 800.20).
- Objective Laboratory Measurements: The numerical results from these tests (e.g., tensile strength in MPa, elongation in %, breakthrough detection time in minutes, powder content in mg/glove).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The "device" itself is manufactured and tested according to engineering and material science principles.
9. How the ground truth for the training set was established
Not applicable, as no training set exists for this type of device.
§ 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.