(90 days)
The nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided text describes the regulatory filing for Nitrile Examination Gloves and includes non-clinical testing results. It does not involve a medical device with an AI algorithm, a diagnostic purpose, or human-in-the-loop performance. Therefore, many of the requested fields are not applicable.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length: S: ≥220mm; M/L/XL: ≥230mm | Length: >230mm / Pass |
| Width: S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | Width: S: 83-85mm / Pass; M: 94-96mm / Pass; L: 110-112mm / Pass; XL: 113-117mm / Pass | ||
| Thickness: Finger: ≥0.05mm; Palm: ≥0.05mm | Thickness: Finger: 0.12-0.15mm / Pass; Palm: 0.08-0.10mm / Pass | ||
| ASTM D5151 | Watertightness (Holes) | Meet the requirements of ASTM D5151 AQL 2.5 | 0/200 / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
§ 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.