(59 days)
A 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.
Powder-free Black 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 text describes the performance testing and acceptance criteria for "Black Nitrile Examination Gloves, Powder Free, Non Sterile." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement | Standard (Acceptance Criteria) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Physical Dimension | Length $\geq$ 230 mm | ||
| Width = 95 + 10 mm | |||
| Thickness $\geq$ 0.05 mm (Finger, Palm, Cuff) | Length = 240.9 mm | ||
| Width = 97.7 mm | |||
| Thickness: |
- Finger = 0.148 mm
- Palm = 0.109 mm
- Cuff = 0.092 mm | Yes |
| Physical Properties | Unaged:
TS (Tensile Strength) = 14 MPa
UE (Ultimate Elongation) = 500 %
Aged:
TS = 14 MPa
UE = 400 % | Unaged:
TS = 18.8 MPa
UE = 679.4 %
Aged:
TS = 21.3 MPa
UE = 767.4 % | Yes |
| Freedom from Pinholes | Acc / Rej = 3 / 4 (This likely refers to an AQL (Acceptable Quality Limit) level, implying a maximum number of accepted or rejected units per sample based on the standard) | Not explicitly stated in numerical terms, but the device is implied to have passed based on "Acc / Rej = 3 / 4" under STANDARDS. | Implied Yes |
| Moisture Content | 0.8% | 0.46% | Yes |
| Powder Residue |
§ 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.