(87 days)
The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
The provided text details the 510(k) summary for the "Vinyl Patient Examination Glove (Yellow)" (K173580) and compares it to a predicate device (K163168). The information specifically relates to the technical specifications and performance of the examination gloves, rather than an AI/ML device or a medical imaging system. Therefore, many of the requested categories in the prompt regarding AI/ML device evaluation are not applicable.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Vinyl Patient Examination Glove (Yellow) are primarily based on established industry standards and specific physical and biological properties. The reported device performance is presented in comparison to a predicate device and adherence to these standards.
| ITEM | Acceptance Criteria (Proposed Device K173580) | Reported Device Performance (Proposed Device K173580) | Predicate Device (K163168) Performance |
|---|---|---|---|
| Product Code | LYZ | LYZ | LYZ |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Class | I | I | I |
| Intended Use | Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner. | Meets intended use. | Meets intended use. |
| Powdered or Powder free | Powder free | Powder free | Powder free |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile. | Meets labeling requirements. | Meets labeling requirements. |
| Length (min) | 230 mm (S, M, L, XL) | S: 230mm, M: 230mm, L: 230mm, XL: 230mm | S: 230mm, M: 235mm, L: 245mm, XL: 245mm (XS: 230mm) |
| Width (tolerance) | +/- 5 mm | S: 85mm, M: 95mm, L: 105mm, XL: 115mm | S: 85mm, M: 95mm, L: 105mm, XL: 115mm (XS: 80mm) |
| Finger Thickness (min) | 0.05 mm | 0.05 mm | 0.05 mm |
| Palm Thickness (min) | 0.08 mm | 0.08 mm | 0.08 mm |
| Comply with ASTM D5250 | Yes | Yes (Analysis 1 and 2 confirm compliance despite differences in specific values) | Yes |
| Colorant | Yellow | Yellow | White, Blue, Yellow |
| Tensile Strength Before Aging (min) | 12 MPa | 12 MPa | 15 MPa |
| Ultimate Elongation Before Aging (min) | 300 % | 300 % | 380 % |
| Tensile Strength After Aging (min) | 12 MPa | 12 MPa | 15 MPa |
| Ultimate Elongation After Aging (min) | 300 % | 300 % | 380 % |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 Level=G-I, AQL=1.5 | Meets this criterion. | Be free from holes when tested in accordance with ASTM D5151 AQL=1.5 |
| Powder Content | Meets requirements of ASTM D5250 | 1.8 mg (Implied to meet requirement) | Meets requirements of ASTM 5250 |
| Material | Vinyl | Vinyl | Vinyl |
| Biocompatibility (Irritation) | Not an irritant (Comply with ISO 10993-10) | Not an irritant | Not an irritant |
| Biocompatibility (Sensitization) | Not a sensitizer (Comply with ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Biocompatibility (Cytotoxicity) | Not show potential toxicity to L-929 cells (Comply with ISO 10993-5) | Not show potential toxicity to L-929 cells | Not show potential toxicity to L-929 cells |
| Label and Labeling | Meet FDA's Requirements of 21 CFR 801 | Meets FDA's requirements. | Meets FDA's requirements. |
2. Sample sized 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 general "test set" sample sizes or data provenance in the context of clinical studies (as it states "No clinical study is included in this submission"). For non-clinical tests like physical properties and freedom from holes, the standards (e.g., ISO 2859-1 for sampling) outline the sampling procedures, but specific sample sizes used in this submission are not explicitly stated. The manufacturer is "NATURE MEDICAL PRODUCTS CO., LTD." in Hebei, China, which suggests the tests were likely conducted in China. These non-clinical tests would be considered prospective for the device being evaluated.
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 as the device is a Vinyl Patient Examination Glove, not an AI/ML device requiring expert medical interpretation for ground truth. The "ground truth" for these types of devices is based on established laboratory testing and adherence to recognized performance standards (e.g., ASTM, ISO standards) for physical and biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable since this document relates to a physical medical device (examination gloves) and not a diagnostic system requiring human interpretation or adjudication for ground truth.
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. The device is an examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Industry Standards: Compliance with established physical and chemical property requirements outlined in standards such as ASTM D5250, ASTM D5151, ASTM D6124.
- Biocompatibility Testing: Results from in vitro and in vivo tests (ISO 10993-5, ISO 10993-10) determining irritation, sensitization, and cytotoxicity.
- Manufacturing Specifications: Adherence to the manufacturer's own design and material specifications.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model.
§ 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.