(118 days)
AT Nitrile Examination Glove 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.
AT Nitrile Examination Glove 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 Violet blue in color having Finger Texture and Ambidextrous and are powder free. The product is non-sterile.
This document is a 510(k) Premarket Notification for the "AT Nitrile Examination Glove Powder Free." It demonstrates substantial equivalence to a predicate device (K210276). As such, it relies on non-clinical data to prove performance rather than clinical studies or AI algorithm evaluation. Therefore, many of the requested sections are not applicable to this type of device.
Here's the breakdown of the available and applicable information based on your request:
1. A table of acceptance criteria and the reported device performance
| Test Category | Specific Test / Feature | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Dimension | Length (S, M, L, XL) | Min 230 mm | S: 247.76 mm, M: 249.53 mm, L: 253.46 mm, XL: 243.53 mm | Pass |
| Width (S) | 80 ± 10 mm | 84.84 mm | Pass | |
| Width (M) | 95 ± 10 mm | 94.46 mm | Pass | |
| Width (L) | 110 ± 10 mm | 105 mm | Pass | |
| Width (XL) | 120 ± 10 mm | 113.15 mm | Pass | |
| Thickness (Palm) | Min 0.05 mm | S: 0.06 mm, M: 0.06 mm, L: 0.07 mm, XL: 0.06 mm | Pass | |
| Thickness (Finger) | Min 0.05 mm | S: 0.09 mm, M: 0.09 mm, L: 0.10 mm, XL: 0.09 mm | Pass | |
| Physical Property | Tensile Strength (Before Aging) | Min 14 MPa | S: 31.57 MPa, M: 27.33 MPa, L: 30.58 MPa, XL: 28.06 MPa | Pass |
| Tensile Strength (After Aging) | Min 14 MPa | S: 29.38 MPa, M: 29.92 MPa, L: 29.91 MPa, XL: 30.40 MPa | Pass | |
| Ultimate Elongation (Before Aging) | Min 500% | S: 534.61%, M: 561.53%, L: 521.53%, XL: 546.15% | Pass | |
| Ultimate Elongation (After Aging) | Min 400% | S: 544.61%, M: 550.76%, L: 499.23%, XL: 517.69% | Pass | |
| Barrier Property | Detection of Holes in Medical Gloves (AQL) | AQL 2.5 | AQL 2.5 | Pass |
| Powder Free Residue | Residual Powder Content (S, M, L, XL) | ≤ 2 mg/glove | S: 0.22 mg/glove, M: 0.36 mg/glove, L: 0.10 mg/glove (XL not explicitly listed, but implies meeting criteria) | Pass |
| Biocompatibility | In Vitro Cytotoxicity | Non-cytotoxic | Under the conditions of the study, cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern. However, in the comparison table it states "Under the conditions of the study, non-cytotoxic." This discrepancy suggests clarification is needed, but the final result is "Pass". | Pass |
| Skin Sensitization | Not a sensitizer | Under the conditions of the study not a sensitizer | Pass | |
| Skin Irritation | Not an irritant | Under the condition of study not an irritant | Pass | |
| Acute Systemic Toxicity | Device extracts do not pose a systemic toxicity concern | Under the condition of study, the device extracts do not pose a systemic toxicity concern | Pass | |
| Material Mediated Pyrogenicity | Device demonstrates a non-pyrogenic response | Under the conditions of the study, the device demonstrate a non-pyrogenic response | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific performance test (e.g., how many gloves were tested for dimensions, tensile strength, barrier properties, or powder residue). It references standards like ASTM D6319-19 and ASTM D5151-19, which would define the appropriate sampling methods and sizes.
The data provenance is from Malaysia, as the manufacturer, AT Glove Engineering SDN. BHD., is located there. The data is retrospective, as it describes the results of tests already performed on the device.
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. The device is a medical glove, and its performance is evaluated against engineering standards and material properties, not against diagnostic "ground truth" established by medical experts for an AI model.
4. Adjudication method for the test set
This information is not applicable. As there are no human readers or diagnostic interpretations involved, there is no adjudication process. Performance is determined by objective measurements against established technical 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. This is not an AI-assisted diagnostic device, so no MRMC studies or AI improvement metrics are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical product (a medical glove), not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:
- Established engineering and biological standards: 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), ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves), and ISO 10993 series (Biological Evaluation of Medical Devices).
- Objective non-clinical test results: Measurements of physical properties (dimensions, tensile strength, elongation), barrier integrity (detection of holes), chemical properties (powder residue), and biological compatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
8. The sample size for the training set
This information is not applicable. This device is a medical glove, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, this question is irrelevant to the device described.
§ 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.