(234 days)
A non-sterile powder free 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. The device is for over-the-counter use.
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.
The provided document is an FDA 510(k) summary for a medical device (Non-sterile Powder Free Nitrile Examination Gloves). It does not describe an AI/ML-driven medical device, nor does it involve image analysis, expert-based ground truth, or MRMC studies. Therefore, many of the requested elements for describing a study proving an AI/ML device meets acceptance criteria are not applicable.
However, I can extract the relevant "acceptance criteria" (performance specifications) and the "study that proves the device meets the acceptance criteria" (non-clinical performance tests) from the document as it pertains to this specific device.
Here's the information based on the provided document:
Device: Non-sterile Powder Free Nitrile Examination Gloves (K210990)
Device Type: Patient Examination Glove (Class I, reserved)
Intended Use: Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use.
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Dimensions | ASTM D6319-19 | Overall Length (mm): Min 230mm | ||
| Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | ||||
| Thickness at Palm (mm): Min 0.05 mm | ||||
| Thickness at Finger Tip (mm): Min 0.05 mm | Not explicitly stated with specific values, but declared as "Passed" | Passed | ||
| Physical properties | ASTM D6319-19 | Before Aging: | ||
| Tensile Strength (MPa) = 14min | ||||
| Ultimate Elongation (%) = 500min | ||||
| After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: | ||||
| Tensile Strength (MPa) = 14min | ||||
| Ultimate Elongation (%) = 400min | Not explicitly stated with specific values, but declared as "Passed" | Passed | ||
| Freedom from pinholes | ASTM D6319-19 | AQL 2.5 (Inspection Level G-1) | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Residual Powder | ASTM D6124-06 (Reapproved 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.