(95 days)
Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Green, Orange, Violet and White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
The provided document describes the performance testing and acceptance criteria for "Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile". This device is a Class I medical device and the submission focuses on its physical and chemical properties rather than an AI/ML algorithm. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimension | D 6319-00aE3 | Length ≥ 230 mm | Length = 246.77 mm |
| Width = 95 ± 10 mm | Width = 94.46 mm | ||
| Thickness: ≥ 0.05 mm (Finger, Palm, Cuff) | Thickness: Finger = 0.150 mm, Palm = 0.095 mm, Cuff = 0.082 mm | ||
| Physical Properties (Unaged) | D 6319-00aE3 | TS = 14 MPa | TS = 15.9 MPa |
| UE = 500 % | UE = 583.4 % | ||
| Physical Properties (Aged) | D 6319-00aE3 | TS = 14 MPa | TS = 22.3 MPa |
| UE = 400 % | UE = 569.2 % | ||
| Freedom from Pinholes | D 6319-00aE3, FDA 21 CFR 800.20 | Acc / Rej = 3 / 4 | 0 piece found |
| Moisture Content | In-house |
§ 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.