(280 days)
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.
§ 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.