(101 days)
The Nitrile Examination Golves Powder Free is 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 acceptance criteria and a study for the "Nitrile Examination Gloves Powder Free" (K212921). This is a physical medical device (gloves), not an AI/ML algorithm or software as a medical device (SaMD). Therefore, many of the requested fields related to AI/ML studies (like effect size of human readers with AI assistance, number of experts for ground truth, adjudication methods, details of training set) are not applicable to this submission.
Here is the information derived from the provided document, with "N/A" for sections not applicable to this physical device:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | S: ≥220mm; M/L/XL: ≥230mm | Length: > 230mm (Pass) |
| ASTM D6319 | Physical Dimensions Test (Width) | S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | S: 86-87mm (Pass); M: 97-98mm (Pass); L: 107-108mm (Pass); XL: 115-116mm (Pass) |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05mm; Palm: ≥0.05mm | S: Finger: 0.10-0.11mm (Pass), Palm: 0.06-0.07mm (Pass); M: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); L: Finger: 0.11-0.12mm (Pass), Palm: 0.06-0.07mm (Pass); XL: Finger: 0.11-0.12mm (Pass), Palm: 0.07mm (Pass) |
| ASTM D5151 | Watertightness Test for Detection of Holes | AQL 2.5 | 0/200 (Pass) |
| ASTM D6124 | Powder Content |
§ 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.