(153 days)
Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Synthetic Polymer- polyethylene - Powder Free Examination Glove. The subject device is a patient examination glove made from Low Density Polyethylene material, Black Color, 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 for Medical Application. The available sizes of the subject devices are Small, Medium, Large. X-Large & XX Large.
The provided text describes the acceptance criteria and the study that proves the device, Synthetic Polymer Glove - Polyethylene (Black), meets these criteria. The device is a non-sterile, disposable examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|
| Sterility | - | Non-sterile (Small, Medium, Large, X Large, XX Large) | - |
| Freedom from hole (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Pass (for all sizes) | Pass |
| Overall Length (mm) | Min 230mm | Small: 261.53, Medium: 260.1, Large: 260.08, X-Large: 259.8, XX-Large: 268.5 | Pass |
| Width (±10 mm) | Small: 80, Medium: 95, Large: 110, X-large: 120, XX-Large: 130 | Small: 86.30, Medium: 99.4, Large: 115.23, X-Large: 123.54, XX-Large: 134.5 | Pass |
| Thickness at Palm (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Thickness at Fingertip (mm) | Min 0.05 mm | 0.06 mm (for all sizes) | Pass |
| Physical Properties - Before Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 18.6, Medium: 17.45, Large: 18.53, X Large: 17.4, XX Large: 18.69 | Pass |
| - Ultimate Elongation (%) | 500% min | Small: 653.43, Medium: 673.5, Large: 689.15, X Large: 636.56, XX Large: 645.83 | Pass |
| Physical Properties - After Accelerated Ageing | |||
| - Tensile strength (MPa) | 14 MPa, min. | Small: 17.8, Medium: 18.13, Large: 18.61, X Large: 18.3, XX Large: 18.34 | Pass |
| - Ultimate Elongation (%) | 400% min | Small: 645.18, Medium: 680.2, Large: 686.15, X Large: 614.58, XX Large: 636.87 | Pass |
| Powder-free Residue (ASTM D6124-06) |
§ 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.