(267 days)
The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The Glide-On Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of polyvinyl chloride (PVC) with an inner coating of polyurethane. This inner polyurethane coating acts as a lubricant to aid in the donning of the gloves when hands are wet, damp or dry. The gloves are offered non-sterile and are available in small, medium, large and extra large sizes.
The document describes the acceptance criteria and the study conducted for Medline Industries, Inc.'s "Glide-On Vinyl Examination Gloves" (K151754).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Complies with ASTM D5250-06 (reapproved 2011)) | Reported Device Performance (Glide-On Vinyl Examination Gloves) |
|---|---|---|
| Dimensions - Length | ≥230mm | Complies with ASTM D5250-06 (reapproved 2011) ≥230mm |
| Dimensions - Width | Small - 85±5mm; Medium - 95±5mm; Large - 105±5mm; Extra Large - 115±5mm | Small - 85±5mm; Medium - 95±5mm; Large - 105±5mm; Extra Large - 115±5mm |
| Dimensions - Thickness | Palm - 0.10±0.02mm; Finger - 0.10±0.02mm | Palm - 0.10±0.02mm; Finger - 0.10±0.02mm |
| Physical Properties (Before/After Aging) | Tensile Strength ≥11MPa; Ultimate Elongation ≥300% | Tensile Strength ≥11MPa; Ultimate Elongation ≥300% |
| Freedom from Holes | G-1, AQL 2.5 (per ASTM D5151-06 (reapproved 2011)) | G-1, AQL 2.5 |
| Residual Powder |
§ 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.