(173 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2019).
The subject device in this 510(k) Notification is Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate, Powder Free & Non sterile Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves & ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The available sizes of the subject devices are Small, Medium, Large, X-Large.
The provided text describes the acceptance criteria and the study that proves the device (Iconic Blue Nitrile Glove) meets them. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance (Iconic Blue Nitrile Glove) | Remarks |
|---|---|---|---|
| Physical Properties (ASTM D6319-19) | |||
| Freedom from hole - ASTM D5151-19 | AQL 2.5 | Pass | Pass |
| Dimensions (Width, Length, Thickness) | Overall Length: Min 230mm; Width (±10mm): S-80, M-95, L-110, XL-120; Thickness (Palm & Fingertip): Min 0.05 mm | Overall Length: 234-244mm; Width: 84.69-119.07mm; Palm Thickness: 0.09-0.1mm; Fingertip Thickness: 0.11-0.12mm | Pass |
| Tensile Strength (Before Aging) | 14 MPa, min. | 20.07-21.82 MPa | Pass |
| Ultimate Elongation (Before Aging) | 500 % min | 836.57-900.24 % | Pass |
| Tensile Strength (After Accelerated Aging) | 14 MPa, min. | 20.35-23.54 MPa | Pass |
| Ultimate Elongation (After Accelerated Aging) | 400 % min | 813.34-878.09 % | Pass |
| Powder-free Residue - ASTM D6124-06 | 240 min. | >240 min. | Pass |
| Carmustine, 3.3 mg/ml | N/A (Predicate: 11.1 min) | 26.6 min (27.5, 26.6, 26.8) | Different from predicate (better performance for subject device), but device labeled with warning for low permeation time. |
| Cisplatin, 1 mg/ml | >240 min. | >240 min. | Pass |
| Cyclophosphamide, 20 mg/ml | >240 min. | >240 min. | Pass |
| Dacarbazine, 10 mg/ml | >240 min. | >240 min. | Pass |
| Doxorubicin HCI, 2 mg/ml | >240 min. | >240 min. | Pass |
| Etoposide, 20 mg/ml | >240 min. | >240 min. | Pass |
| Fluorouracil, 50 mg/ml | >240 min. | >240 min. | Pass |
| Methotrexate, 25 mg/ml | >240 min. | >240 min. | Pass |
| Mitomycin C, 0.5 mg/ml | >240 min. | >240 min. | Pass |
| Mitoxantrone, 2 mg/ml | >240 min. | >240 min. | Pass |
| Oxaliplatin, 5 mg/ml | >240 min. | >240 min. | Pass |
| Paclitaxel, 6 mg/ml | >240 min. | >240 min. | Pass |
| Thiotepa, 10 mg/ml | N/A (Predicate: 21.6 min) | 56.0 min (58.4, 56.5, 56.0) | Different from predicate (better performance for subject device), but device labeled with warning for low permeation time. |
| Vincristine Sulfate, 1 mg/ml | >240 min. | >240 min. | Pass |
| Opioid Drugs Permeation (ASTM D6978-05 (2019)) | Minimum Breakthrough Detection Time | ||
| Fentanyl Citrate Injection, 100mcg/2ml | >240 min. | >240 min. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each test conducted but references standards like ASTM D6319-19 for physical properties, which would imply a specific sampling plan within that standard (e.g., AQL 2.5, AQL 4.0 inspection level S-2). For chemotherapy drug permeation, three specimens were tested for each drug, as indicated by "Minimum Breakthrough Detection Time (Specimen 1,2,3)".
The data provenance is not explicitly stated in terms of country of origin. The studies are non-clinical (laboratory tests) and are retrospective in the sense that they were performed to demonstrate compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The evaluations are based on standardized laboratory tests (e.g., ASTM, ISO standards) rather than expert interpretation of medical images or patient data. The "ground truth" is determined by measurements against predefined quantitative criteria and methodologies outlined in these standards.
4. Adjudication method for the test set
This section is not applicable as the tests are objective, quantitative measurements against established standards. There is no subjective interpretation requiring expert adjudication.
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
This section is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool or an imaging system. 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
This section is not applicable. The device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through material and chemical resistance tests.
7. The type of ground truth used
The ground truth used for these studies is based on standardized, objective measures and methodologies defined by established industry and regulatory standards, including:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application (for physical properties like dimensions, tensile strength, elongation).
- ASTM D5151-19: Standard for Freedom from hole (pinholes).
- ASTM D6124-06: Standard for Residual Powder.
- ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical breakthrough times).
- ISO 10993-5 (Biological evaluation of medical devices - Part 5): Tests for in vitro cytotoxicity.
- ISO 10993-10 (Biological evaluation of medical devices - Part 10): Tests for irritation and skin sensitization.
- ISO 10993-11 (Biological evaluation of medical devices - Part 11): Tests for systemic toxicity.
The "ground truth" is the result of these specific test procedures and direct measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This section is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the context of AI or algorithms.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above (not an AI/ML 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.