(92 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) summary for Disposable Synthetic Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing against established standards. There is no information in this document about a study conducted to "prove the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic algorithm or a comparative effectiveness study. This document is a regulatory submission for a Class I medical device (examination gloves), which have different evaluation requirements than, for example, AI-powered diagnostic software.
Therefore, many of the specific questions about "acceptance criteria," "device performance," "sample size for test set," "ground truth," "MRMC," and "standalone performance" are not applicable in the context of this document. This document details how the device meets regulatory and standard requirements, not how it performs in a diagnostic or clinical efficacy study.
However, I can extract the relevant information regarding the performance characteristics and safety evaluations presented in the document, framed as how the device demonstrates substantial equivalence and meets referenced standards.
1. A table of acceptance criteria and the reported device performance
For examination gloves, "acceptance criteria" are typically defined by recognized consensus standards which specify physical properties, freedom from holes, and biocompatibility. The "reported device performance" refers to the results of tests conducted to ensure the device meets these standards.
| Acceptance Criteria (from referenced ASTM/ISO Standards) | Reported Device Performance (K210520) |
|---|---|
| Physical Properties (per ASTM D5250) | |
| - Tensile Strength (Before Aging): 11MPa, min | Average 16.9MPa (subject device) |
| - Ultimate Elongation (Before Aging): 300% min | Average 550% (subject device) |
| - Tensile Strength (After Aging): 11MPa, min | Average 14.4MPa, min (subject device) |
| - Ultimate Elongation (After Aging): 300% min | Average 500% (subject device) |
| - Overall compliance with ASTM D5250 for physical properties | Complies with ASTM D5250 |
| Freedom from Holes (per ASTM D5151) | |
| - Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 |
| Powder Content (per ASTM D6124) | |
| - Meet the requirements of ASTM D6124 | 0.01 mg per glove, Meet the requirements of ASTM D6124 (subject device) |
| Biocompatibility (per ISO 10993-10 and ISO 10993-5) | |
| - Irritation: Not an irritant | Under the conditions of the study, not an irritant (subject device) |
| - Sensitization: Not a sensitizer | Under conditions of the study, not a sensitizer (subject device) |
| - Cytotoxicity: No potential toxicity to L-929 cells | Under conditions of the study, did not show potential toxicity to L-929 cells (subject device) |
| Device Dimensions (per ASTM D5250 requirements for length, width, thickness) | |
| - Length, mm: 230 min | Length range: 230 mm (S, M, L, XL) |
| - Width, mm: Specific ranges for S, M, L, XL with ±5 tolerance | Width ranges: S (85mm), M (95mm), L (105mm), XL (115mm) with ±5 tolerance |
| - Thickness, mm: Finger 0.08 min; Palm 0.08 min | Thickness: Finger 0.08 min; Palm 0.08 min |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for tensile strength or holes). It references compliance with standards like ASTM D5151, which would imply specific sampling plans are followed within those standards. The data provenance is implied to be from the manufacturer, Shandong Shengshixincheng Medical Science & Technology Co., Ltd. (China), which conducted the tests to verify design specifications. The nature of these tests is prospective for the submission, meaning they were performed specifically to support the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength, barrier integrity, biocompatibility), not by expert consensus on clinical images or diagnoses. The testing is objective and quantitative, performed in a lab setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/imaging studies where interpretations can vary. Non-clinical tests for gloves involve standardized laboratory procedures with measurable outcomes.
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 is not applicable. MRMC studies and AI assistance are relevant for diagnostic or interpretive devices; this document concerns examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical product (gloves), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by the objective performance criteria specified in international consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5). Successful compliance with these measured physical/chemical/biological properties constitutes the "ground truth" for showing the device is safe and effective as examination gloves.
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical device like examination gloves in the way it applies to machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" for this type of device.
§ 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.