(285 days)
Amazing+ Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.
The provided text is a 510(k) Summary for a medical device: "Amazing+ Latex Examination Powder Free Gloves." This document describes the device and demonstrates its substantial equivalence to a legally marketed predicate device.
However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically in the context of an AI-powered medical device (e.g., sample size for test set, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment for training and test sets).
The provided 510(k) Summary does not describe an AI medical device. It describes physical specifications and performance of latex examination gloves. Therefore, many of the requested fields are not applicable to this type of device.
Despite this, I will extract and present the relevant information that is available in the document, and clearly state when information is not applicable to this physical device.
Device: Amazing+ Latex Examination Powder Free Gloves
K Number: K212597
Predicate Device: JR MEDIC Blue Latex Examination Powder Free Gloves (K192329)
1. A table of acceptance criteria and the reported device performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance | Comparison to Predicate |
|---|---|---|---|---|
| Dimensions - Length | ASTM D3578-2019 | Min 230 mm for all sizes | X-Small 305 mm, Small 306 mm, Medium 307 mm, Large 308 mm, X-Large 310 mm | Similar |
| Dimensions - Width | ASTM D3578-2019 | X-Small 70+/-10 mm, Small 80+/-10mm, Medium 95+/-10 mm, Large 111+/-10 mm, X-Large 115+/-10 mm | X-Small 76 mm, Small 85 mm, Medium 96 mm, Large 106 mm, X-Large 116 mm | Similar |
| Dimensions - Thickness | ASTM D3578-2019 | Palm > 0.08 mm min, Finger > 0.08 mm min for all sizes | Palm: 0.16mm (all sizes), Finger: 0.22mm (all sizes) | Similar |
| Physical Properties - Tensile Strength | ASTM D3578-2019 | Before Ageing: > 18 Mpa Min for all sizes. After Ageing: > 14 Mpa Min for all sizes. | Before Ageing: X-Small 22.07 Mpa, Small 22.15 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 Mpa. After Ageing: X-Small 18.49 Mpa, Small 18.56 Mpa, Medium 18.67 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa. | Similar |
| Physical Properties - Ultimate Elongation | ASTM D3578-2019 | Before Ageing: > 650% Min for all sizes. After Ageing: > 500% Min for all sizes. | Before Ageing: X-Small 858%, Small 869%, Medium 874%, Large 880%, X-Large 882%. After Ageing: X-Small 841%, Small 848%, Medium 854%, Large 860%, X-Large 862%. | Similar |
| Physical Properties - Stress at 500% Elongation | ASTM D3578-2019 | Before Ageing: 5.5 Mpa Max for all sizes. | Before Ageing: X-Small 5.1 Mpa, Small 5.1 Mpa, Medium 5.2 Mpa, Large 5.2 Mpa, X-Large 5.2 Mpa. | N/A |
| Water Tightness (Holes) | ASTM D5151-2019 | AQL 2.5 | Gloves Pass AQL 1.5 | Same |
| Powder Free Residue | ASTM D6214 | Under the conditions of the study non pyrogenic | Under the conditions of the study, non-pyrogenic | |
| Biocompatibility - Acute Systemic Toxicity Test | ISO 10993-11:2017(E) | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Same |
| Extractable Protein | ASTM D 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber | 200 µg/ dm² Max for all sizes | 43.65 µg/dm² (all sizes) | N/A (Not compared to predicate in table, but meets criteria) |
Information Not Applicable to this Device (as it's a physical product, not an AI/software device):
Given that the device is "Amazing+ Latex Examination Powder Free Gloves," the following sections of your request are not applicable as they pertain to AI/software functionality and clinical studies that are not performed for basic Class I examination gloves:
- 2. Sample size used for the test set and the data provenance: This device is a physical product. Testing involves laboratory measurements on physical samples (e.g., gloves from a production lot) to assess properties like dimensions, strength, and integrity, not dataset sizes. The provenance is from "Amazing Rubber Products Pvt. Ltd." in Cochin, Kerala, India. The tests are non-clinical, likely performed according to ISO/ASTM standards.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized measurement methods (e.g., ASTM standards), not expert opinion or consensus.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Physical measurements do not require adjudication.
- 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: Not applicable. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for device performance is based on the specified ASTM and ISO standards for physical and chemical properties and biocompatibility testing.
- 8. The sample size for the training set: Not applicable. There is no "training set" for physical examination gloves; manufacturing process controls ensure consistent product.
- 9. How the ground truth for the training set was established: Not applicable. See above.
Summary of Non-Clinical Performance Data (Reiterated from document):
The performance test data of the non-clinical tests meet the following standards:
- ASTM D 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTM D 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
Clinical Testing Summary:
- "This section is not applicable because clinical data not needed for gloves." (As stated in the document).
§ 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.