(89 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
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.
The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.
Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.
However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.
Here's the information that is applicable based on the provided document:
1. Table of acceptance criteria and the reported device performance:
The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).
| Characteristic | Acceptance Criteria (Predicate Device K022091 Reported Performance / Standard) | Reported Device Performance (K191092) | Comparison |
|---|---|---|---|
| Physical Properties (Before Aging) | |||
| Average Tensile Strength (Mpa) | 17.00 Mpa | 17.44 Mpa | Similar |
| Average Ultimate Elongations | 500% | 519.4% | Similar |
| Physical Properties (After Aging) | |||
| Average Tensile Strength (Mpa) | 15 Mpa | 15 Mpa | Similar |
| Average Ultimate Elongations | 475% | 481.96% | Similar |
| Dimensions (Medium Size) | |||
| Overall Length | Average over 230.00 mm | Average over 232.23mm | Similar |
| Width of Palm | Average 95.00mm | Average 95.08mm | Same |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Same |
| Finger Thickness | Average 0.090 mm | Average 0.090 mm | Similar |
| Other Tests | |||
| Residual Powder |
§ 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.