(112 days)
The Medical PVC Examination Gloves 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, Medical PVC Examination Gloves are disposable devices 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 clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250.
The proposed device is not provided as sterilized
The proposed device is made of vinyl chloride.
The provided text describes the 510(k) submission for "Medical PVC Examination Gloves" and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The document explicitly states the device is a physical product (gloves) and outlines its physical and performance specifications, as well as biocompatibility tests.
Therefore, I cannot provide the requested information for acceptance criteria and a study from an AI/ML perspective because the provided document is not about an AI/ML device.
However, I can extract the acceptance criteria and reported device performance for the Medical PVC Examination Gloves based on the provided document.
Acceptance Criteria and Reported Device Performance (for Medical PVC Examination Gloves):
| Acceptance Criteria | Proposed Device Performance |
|---|---|
| Physical Dimensions (ASTM D5250) | |
| Length (mm) | |
| XS | 230 min |
| S | 230 min |
| M | 230 min |
| L | 230 min |
| XL | 230 min |
| Width (mm) | |
| XS | 80 ± 5 |
| S | 85 ± 5 |
| M | 95 ± 5 |
| L | 105 ± 5 |
| XL | 115 ± 5 |
| Thickness (mm) | |
| Finger | 0.08 min |
| Palm | 0.08 min |
| Cuff | 0.08 min |
| Performance and Physical Specifications (ASTM D5250) | |
| Before Aging | |
| Tensile Strength | 11 MPa, min |
| Ultimate Elongation | 300 % min |
| After Aging | |
| Tensile Strength | 11 MPa, min |
| Ultimate Elongation | 300 % min |
| Pinhole AQL | 2.5 |
| Freedom from Holes (ASTM D5151) | Be free from holes |
| Powder Content (ASTM D6124) | Less than 2 mg per glove |
| Biocompatibility (ISO 10993-10) | |
| Irritation | Not an irritant |
| Sensitization | Not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) | No mortality or evidence of systemic toxicity |
Regarding the other requested points for an AI/ML study, the document does not provide the information:
- Sample sizes used for the test set and the data provenance: Not applicable, as this is a physical medical device (gloves).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
- If a standalone performance (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for these gloves is established by laboratory testing against physical and chemical standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The study described in this 510(k) summary is a series of bench tests conducted to verify that the proposed device (Medical PVC Examination Gloves) met design specifications and was substantially equivalent to the predicate device. These tests align with the listed ASTM and ISO standards for physical properties, performance, and biocompatibility of examination gloves. The document states: "The test results demonstrated that the proposed device complies with the following standards: ASTM D5250-19, ASTM D5151-19, ASTM D6124-17, ISO 10993-10:2010, ISO 10993-11:2017."
§ 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.