(230 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.
Below are the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Biocompatibility | |||
| Skin Sensitization Potential | Under the conditions of the testing, not a sensitizer. | Primary irritation indexes of polar and non-polar test group were both 0%. | Pass |
| Irritation Potential | Under the conditions of the testing, not an irritant. | Skin sensitization rates of polar and non-polar extract group were both 0%. | Pass |
| In Vitro Cytotoxicity Potential | Under the conditions of the testing, non-cytotoxic. | Cell viability of the 100% test article extract was 86.2%. | Pass |
| Physical Performance | |||
| Residual Powder on Medical Gloves | Powder residue limit of 2.0 mg/glove (ASTM D6124-06) | 1.9 mg/glove | Pass |
| Detection of Holes | AQL: 2.5 (ISO 2859-1) (ASTM D5151-19) | 0 gloves of failure | Pass |
| Physical Dimensions (ASTM D6319-19) | |||
| Length | ≥270 mm for all sizes (XS, S, M, L, XL, XXL) | Range: 287-301 mm (across sizes) | Pass |
| Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | XS: 78-80mm; S: 84-86mm; M: 96-97mm; L: 105-107mm; XL: 113-115mm; XXL: 122-124mm | Pass |
| Thickness (Finger) | ≥0.05 mm | 0.082-0.185 mm | Pass |
| Thickness (Palm) | ≥0.05 mm | 0.065-0.123 mm | Pass |
| Physical Properties: Before Aging (ASTM D6319-19 & ASTM D412-16) | |||
| Tensile Strength | ≥14 MPa | 19.9-28.9 MPa | Pass |
| Ultimate Elongation | ≥500% | 540-580% | Pass |
| Physical Properties: After Accelerated Aging (ASTM D6319-19 & ASTM D412-16 & ASTM D573-04) | |||
| Tensile Strength | ≥14 MPa | 20.2-29.1 MPa | Pass |
| Ultimate Elongation | ≥400% | 508-528% | Pass |
| Permeation Characteristics (ASTM D6978-05) | |||
| Carmustine (3.3 mg/ml) | Not explicitly stated as acceptance criteria, but listed as having a minimum breakthrough time in the indications for use. | 21.1 (24.2, 21.1, 25.3) min. (Note: Warning - Do not use) | N/A |
| Thiotepa (10 mg/ml) | Not explicitly stated as acceptance criteria, but listed as having a minimum breakthrough time in the indications for use. | 74.9 (74.9, 96.7, 79.0) min. (Note: Warning - Do not use) | N/A |
| Other Chemotherapy Drugs and Fentanyl Citrate | Generally, Breakthrough Detection Time > 240 minutes for most tested drugs. | > 240 minutes for most listed drugs (see full list in original document) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to standard test methods like ASTM D6319-19 which would define typical sample sizes for such evaluations.
- Data provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer or a contracted lab. The country of origin of the data is not specified beyond the manufacturer's address in Hebei, P.R. China. The data is prospective in nature, as it was generated to demonstrate device performance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes non-clinical (bench) testing of physical properties and chemical permeation, not a study involving human expert interpretation for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes non-clinical (bench) testing.
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 information is not applicable as the document describes non-clinical (bench) testing of a medical glove, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the document describes non-clinical (bench) testing of a medical glove, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is established by industry standards and defined acceptance criteria. For example:
- Physical dimensions: Measured values compared against specified ranges (e.g., length ≥270mm).
- Physical properties (tensile strength, elongation): Measured values compared against minimum performance requirements defined in ASTM standards.
- Freedom from holes: Tested according to ASTM D5151-19, with acceptance based on AQL (Acceptable Quality Limit) of 2.5.
- Residual powder: Measured amount compared against a limit of
§ 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.