(269 days)
Best Glove - Nitrile Powder Free 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.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided document describes the acceptance criteria and performance of the BEST GLOVE -NITRILE POWDER FREE EXAMINATION GLOVE as determined through non-clinical testing. It does not involve AI or algorithms, so most of the requested information about studies involving expert Ground Truth, MRMC studies, or multi-reader studies is not applicable.
Here's the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method & Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|
| Dimension (ASTM D6319-19) | |||
| Length | Min 230 mm for all sizes | Small: 243 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 240 mm | Pass |
| Width | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm | Pass |
| Thickness (Palm & Finger) | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | Small: Palm 0.09 mm, Finger: 0.13 mm; Medium: Palm: 0.06 mm, Finger: 0.08 mm; Large: Palm 0.09 mm, Finger: 0.12 mm; Extra Large: Palm 0.09 mm, Finger: 0.12 mm | Pass |
| Watertight test (ASTM D5151-19) | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0 (Zero), Medium: 0 (Zero), Large: 0 (Zero), Extra Large: 0 (Zero) defects. (The batch size for this sampling is 35,001-150,000, under code L equivalent to 200 pcs with accept 7 and reject 8 to be accept under AQL 1.5) | Pass |
| Residual powder (ASTM D6124-06, Reapproved 2017) | 2 mg per glove or less | Small: 1.42 mg/glove, Medium: 0.50 mg/glove, Large: 1.34 mg/glove, Extra Large: 1.36 mg/glove | Pass |
| Physical Properties - Tensile Strength (ASTM D6319-19) | Before Ageing: 14 MPa minimal for all sizes; After Ageing: 14 MPa minimal for all sizes | Before Ageing: Small: 18.37 MPa, Medium: 30.62 MPa, Large: 18.30 MPa, Extra Large: 18.20 MPa; After Ageing: Small: 14.08 MPa, Medium: 31.89 MPa, Large: 14.00 MPa, Extra Large: 14.00 MPa | Pass |
| Physical Properties - Ultimate Elongation (ASTM D6319-19) | Before Ageing: 500% Min for all sizes; After Ageing: 400% Min for all sizes | Before Ageing: Small: 612%, Medium: 500%, Large: 620%, Extra Large: 587%; After Ageing: Small: 408%, Medium: 499%, Large: 403%, Extra Large: 416% | Pass |
| Biocompatibility: Primary Skin Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant | Same |
| Biocompatibility: Dermal Sensitization (ISO 10993-10) | Not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility: In vitro cytotoxicity (ISO10993-5) | Non-cytotoxic | Under the conditions of the study cytotoxic for undiluted (neat) and 1:2 dilutions but non-cytotoxic for 1:4, 1:8 and 1:16 dilutions. Moreover, under the conditions of the study, did not induce any systemic toxicity. (This is a "Similar" comparison to the predicate, implying acceptance for the device) | Similar |
| Biocompatibility: Acute Systemic Toxicity (ISO10993-11) | Extracts do not pose a systemic toxicity | Under the conditions of the study, did not induce any systemic toxicity. | Same |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension, Thickness, Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes for these tests are not explicitly stated in the table, but the results are given for different sizes (Small, Medium, Large, Extra Large) of the gloves. The tests were performed against specified ASTM standards (ASTM D6319-19).
- Watertight Test: A sample size of 200 pieces was used for the watertight test for each size, following a single sampling plan code L for a batch size of 35,001-150,000.
- Residual Powder: A sample size of 5 pieces was used for the residual powder test for each size.
- Biocompatibility Tests: The document states "Under the conditions of the study" for these tests, implying specific samples were used for the in-vitro and in-vivo (animal) tests, but exact numbers of samples/animals are not provided in this summary.
- Data Provenance: The document is a 510(k) Premarket Notification from Thailand (Bestsafe Glove Co., LTD is based in Rayong, Thailand), indicating the tests were likely conducted in or overseen by the manufacturer in Thailand, in accordance with international standards (ASTM, ISO). The studies are non-clinical (laboratory/material testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes material property tests and biocompatibility tests for medical gloves, not a diagnostic device involving expert interpretation or "ground truth" established by experts in a clinical context. The "ground truth" for these tests is defined by the objective measurement criteria within the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as these are objective performance measurements against established standards for physical and chemical properties of gloves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical glove, not an imaging or diagnostic AI tool. Therefore, no MRMC study was performed or is relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (glove), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for these tests are the objective measurement criteria defined by the specified international standards:
- ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, thickness, physical properties).
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves (for watertight test).
- ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for primary skin irritation and dermal sensitization).
- ISO 10993-5:2009(E): Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-11:2017(E): Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process for gloves is subject to quality control and batch testing, which can be seen as ongoing verification of product consistency, but not "training data" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.