(149 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners
The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
The provided document is a 510(k) Premarket Notification for Powder-Free Clear Vinyl Patient Examination Gloves (K190095). This document is a submission to the FDA (Food and Drug Administration) for a Class I medical device. For such devices, the primary demonstration of meeting acceptance criteria relies on adhering to recognized performance standards and biocompatibility tests.
The document does not describe an AI medical device or a study involving human readers and AI assistance. Therefore, information related to AI-specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) is not applicable and is not present in the document.
Instead, the acceptance criteria and performance data pertain to the physical and biological properties of the examination gloves.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Powder-Free Clear Vinyl Patient Examination Gloves (K190095)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (K190095) | Comparison to Predicate Device (K022091) |
|---|---|---|
| ASTM D5250-06 (Poly Vinyl Chloride Gloves for Medical Applications) | ||
| Before Aging: | ||
| Tensile Strength (Mpa) | Average 17.44 Mpa | Predicate: Average 17.00 Mpa (Similar) |
| Ultimate Elongations (%) | Average 519.4% | Predicate: Average 500% (Similar) |
| After Aging: | ||
| Tensile Strength (Mpa) | Average 15 Mpa | Predicate: Average 15 Mpa (Similar) |
| Ultimate Elongations (%) | Average 481.96% | Predicate: Average 450% (Similar) |
| Overall Length (Medium Size) | Average 232.23 mm | Predicate: Average 232.23 mm (Same) |
| Width of Palm (Medium Size) | Average 95.08 mm | Predicate: Average 95.08 mm (Same) |
| Palm Thickness | Average 0.095 mm | Predicate: Average 0.095 mm (Same) |
| Finger Thickness | Average 0.090 mm | Predicate: Average 0.090 mm (Same) |
| ASTM D6124-06 (Residual Powder and Non-powder Solids on Medical Gloves) | ||
| Residual powder 30% | Met (Device extract not cytotoxic to mammalian cell culture - mouse fibroblasts L929 cells) | Predicate: N/A (Note: The predicate device submission (K022091) did not explicitly list cytotoxicity testing in this comparison table, indicating "Different" in the comparison column for this specific test. However, the proposed device conducted and passed this test, adding to its safety profile.) |
2. Sample Size Used for the Test Set and Data Provenance:
- ASTM D5151-06 (Pinhole/Water Leak Test): 125 gloves were tested for the AQL (Acceptable Quality Level) 2.5 sampling.
- Other standards (e.g., ASTM 5250-06 for physical properties, ASTM D6124-06 for residual powder, ISO 10993 series for biocompatibility): Specific sample sizes for these tests are not explicitly stated within the provided text, but industry standards dictate typical sample sizes for such evaluations.
- Data Provenance: The manufacturer is Anhui Intco Medical Products Co., Ltd., located in Anhui Province, China. The testing was conducted by the manufacturer to demonstrate compliance with international standards. The data is retrospective, generated for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This document pertains to the physical and biological testing of a medical device (examination gloves), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is established by the validated methodologies of the ASTM and ISO standards themselves.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a submission for a Class I medical device based on performance standards and biocompatibility, there is no "adjudication" in the sense of expert consensus on image interpretation. The results are quantitative and objective measurements against established standard criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not relevant for the type of device (examination gloves) and the nature of the 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- The ground truth is based on validated methodologies and acceptance criteria defined by international standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards outline the methods for objectively measuring physical properties (e.g., tensile strength, elongation, dimensions, powder residue, pinholes) and biological responses (e.g., irritation, sensitization, cytotoxicity).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" as this is not an AI/ML 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.