(120 days)
Clover Glove Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Clover Glove Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
The acceptance criteria and performance of the Clover Glove Nitrile Examination Gloves Powder Free are described below based on the provided FDA 510(k) summary.
1. A table of acceptance criteria and the reported device performance
| Test Category | Characteristic/Test | Acceptance Criteria (ASTM D6319-19 unless specified) | Reported Device Performance (Clover Glove) | Result |
|---|---|---|---|---|
| Dimensions | Length | 230mm Min | S: 245.15mm, M: 247.1mm, L: 248.30mm | Pass |
| Width (for Medium size) | 95mm ±10 | M: 92.69 mm (within 95±10) | Pass | |
| Width (for Small size) | 80mm ±10 | S: 83mm (within 80±10) | Pass | |
| Width (for Large size) | 110mm ±10 | L: 108.07mm (within 110±10) | Pass | |
| Thickness (Palm) | S: 0.05 mm Min, M: 0.05 mm Min, L: 0.05 mm Min | S: 0.08 mm, M: 0.09 mm, L: 0.09 mm | Pass | |
| Thickness (Finger) | S: 0.05 mm Min, M: 0.05 mm Min, L: 0.05 mm Min | S: 0.123mm, M: 0.138mm, L: 0.14mm | Pass | |
| Physical Property | Tensile Strength (Before Aging) | 14 MPa Min | S: 30.60 MPa, M: 31.72 MPa, L: 37.01 MPa | Pass |
| Tensile Strength (After Aging) | 14 MPa Min | S: 30.66 MPa, M: 30.80 MPa, L: 35.46 MPa | Pass | |
| Ultimate Elongation (Before Aging) | 500% Min | S: 604.61%, M: 575.38%, L: 596.92% | Pass | |
| Ultimate Elongation (After Aging) | 400% Min | S: 573.84%, M: 580%, L: 566.15% | Pass | |
| Barrier Property | Detection of Holes (AQL) (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 for all sizes | AQL 2.5 for all sizes | Pass |
| Powder Residue | Powder Free Residue (ASTM D6124-06) | ≤2 mg/glove Max | S: 0.42mg, M: 0.34mg, L: 0.20mg | Pass |
| Biocompatibility | In Vitro Cytotoxicity (ISO 10993-1:2018) | Under the conditions of the study, non-cytotoxic. | Under the conditions of the study, cytotoxic. * | Different |
| Skin Sensitization (ISO 10993-1:2018) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Pass | |
| Skin Irritation (ISO 10993-1:2018) | Under the condition of study not an irritant | Under the condition of study not an irritant | Pass | |
| Acute Systemic Toxicity (ISO 10993-1:2018) | Device extracts do not pose a systemic toxicity concern. | Device extracts do not pose a systemic toxicity concern. | Pass | |
| Material Mediated Pyrogenicity (ISO 10993-1:2018) | Device did not demonstrate a material mediated pyrogenicity response. | Device did not demonstrate a material mediated pyrogenicity response. | Pass |
*Note on Cytotoxicity: The device initially showed a cytotoxic response, but additional testing for acute systemic toxicity concluded that the observed cytotoxicity was not a significant clinical concern, as it did not induce systemic toxicity in test animals.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance or biocompatibility tests. It refers to "actual data" for the device, implying that testing was conducted on samples of the Clover Glove.
The provenance of the data is that it was generated for the purpose of this 510(k) submission, likely by Clover Glove Company Limited or a contracted testing facility. The specific country of origin for the testing is not stated, but the company itself is located in Thailand. The testing appears to be prospective as it's specifically conducted 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 device is a medical glove. The 'ground truth' is established by adherence to recognized international standards (ASTM) and biocompatibility testing according to ISO 10993-1, rather than expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
This information is not applicable as the device is a medical glove. The performance is assessed against predefined quantitative and qualitative criteria from established standards, not through adjudication of expert opinions.
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 device is a medical glove and not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical glove and not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the performance tests (dimensions, physical properties, barrier properties, powder residue) is based on established standard specifications, specifically ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves).
For biocompatibility, the ground truth is established by adherence to internationally recognized standards for biological evaluation of medical devices, specifically ISO 10993-1:2018 (Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process).
8. The sample size for the training set
This information is not applicable as the device is a physical medical product (gloves) and not a machine learning model requiring a 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.