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510(k) Data Aggregation
(280 days)
Bestsafe Glove CO., LTD.
A powder-free 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
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) and are powder free.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Dimension | ASTM D3578-19 | Length | Min 230 mm for all sizes | Small: 240 mm, Medium: 240 mm, Large: 240 mm, Extra Large: 241 mm (All Pass) |
| Width | Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 111 ± 10 mm, Extra Large: 120 ± 10 mm | Small: 85 mm, Medium: 93 mm, Large: 105 mm, Extra Large: 115 mm (All Pass) | ||
| Thickness (Palm) | 0.08 mm min for all sizes | Small: 0.09 mm, Medium: 0.09 mm, Large: 0.10 mm, Extra Large: 0.09 mm (All Pass) | ||
| Thickness (Finger) | 0.08 mm min for all sizes | Small: 0.12 mm, Medium: 0.12 mm, Large: 0.13 mm, Extra Large: 0.12 mm (All Pass) | ||
| Physical Properties | ASTM D3578-19 | Tensile Strength (Before Aging) | 18 MPa Minimal for all sizes | Small: 18.04 MPa, Medium: 19.13 MPa, Large: 18.26 MPa, Extra Large: 18.64 MPa (All Pass) |
| Tensile Strength (After Aging) | 14 MPa Minimal for all sizes | Small: 15.02 MPa, Medium: 18.12 MPa, Large: 16.01 MPa, Extra Large: 15.06 MPa (All Pass) | ||
| Ultimate Elongation (Before Aging) | 650% Min for all sizes | Small: 651%, Medium: 654%, Large: 650%, Extra Large: 650% (All Pass) | ||
| Ultimate Elongation (After Aging) | 500% Min for all sizes | Small: 501%, Medium: 601%, Large: 501%, Extra Large: 502% (All Pass) | ||
| Watertight Test | ASTM D5151-19 | Detection of Holes | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8 | Small: 0, Medium: 0, Large: 0, Extra Large: 0 (All Pass) |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | Residual powder in gloves | 2 mg per glove or less | Small: 0.62 mg/glove, Medium: 0.46 mg/glove, Large: 0.61 mg/glove, Extra Large: 0.61 mg/glove (All Pass) |
| Protein Content | ASTM D5712-15 | Extractable protein in natural rubber | Less than 200 µg/dm² | Small: 124.36 µg/dm², Medium: 140.78 µg/dm², Large: 134.26 µg/dm², Extra Large: 159.46 µg/dm² (All Pass) |
| Biocompatibility | ISO 10993-10 | Primary Skin Irritation | Not a primary skin irritant | Not a primary skin irritant under the conditions of the study (Pass) |
| Dermal Sensitization | Not a contact sensitizer | Not a contact sensitizer under the conditions of the study (Pass) | ||
| ISO 10993-5 | In vitro cytotoxicity | No data available for predicate (Tested for subject device) | Cytotoxic for undiluted and 1:2 dilutions, non-cytotoxic for 1:4, 1:8, 1:16, 1:32 dilutions for subject device (Different from predicate, but indicates testing) | |
| ISO 10993-11 | Acute Systemic Toxicity | No data available for predicate (Tested for subject device) | Did not induce any systemic toxicity for subject device (Different from predicate, but indicates testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Dimension Tests: While specific sample sizes for each dimension measurement aren't individually listed, the watertight test indicates a sample size of 200 pieces for that particular test. For residual powder, the sample size was 5 pieces. For protein content, the sample size was 3 pieces.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that the manufacturer is Bestsafe Glove Co., LTD. based in Thailand, it is highly likely that the testing was conducted in Thailand or by laboratories compliant with international standards on behalf of the manufacturer. The tests are presented as part of a 510(k) submission, typically involving tests specifically conducted for the device seeking clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the document describes performance testing for medical gloves against established ASTM and ISO standards, not a diagnostic or AI-driven device requiring human expert ground truth for image interpretation or similar tasks. The "ground truth" here is defined by the objective measurement criteria within the specified standards.
4. Adjudication Method for the Test Set
- This information is not applicable for the same reasons as point 3. The testing involves objective measurements against established numerical and qualitative criteria defined by the standards.
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. The device is a physical medical glove, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical medical glove, not a software or AI-based device.
7. The Type of Ground Truth Used
- The ground truth for the performance of the gloves is established through objective measurements against predefined criteria and thresholds set by international standards for medical gloves, specifically:
- ASTM D3578-19 (Standard Specification for Rubber Examination Gloves)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D5712-15 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
8. The Sample Size for the Training Set
- This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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(269 days)
Bestsafe Glove CO., LTD
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.
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