(87 days)
The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| ITEM | Acceptance Criteria (Proposed Device K173561) | Reported Device Performance (Proposed Device K173561) |
|---|---|---|
| Product Code | LYZ | LYZ |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Class | I | I |
| Intended Use | Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner. | Meets this description. |
| Powdered or Powered free | Powder-free | Powder-free |
| Design Feature | Ambidextrous | Ambidextrous |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Meets these requirements. |
| Dimensions (Length, Width) | Complies with ASTM D 5250 specifications (specific values depend on size: e.g., Length min 230mm, Width ±5mm of specific values) | All proposed device meets the specifications of ASTM D 5250. |
| Thickness (Finger, Palm) | Finger: 0.05 min, Palm: 0.08 min | Finger: 0.05 min, Palm: 0.08 min |
| Colorant | Yellow | Yellow |
| Physical Properties | Before Aging: Tensile Strength: 12 MPa, min; Ultimate Elongation: 300 % min | Achieved 12 MPa, min (Tensile Strength); 300 % min (Ultimate Elongation) |
| After Aging: Tensile Strength: 12 MPa, min; Ultimate Elongation: 300 % min | Achieved 12 MPa, min (Tensile Strength); 300 % min (Ultimate Elongation) | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 Level=G-I, AQL=1.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=1.5 |
| Powder Content | Meets the requirements of ASTM 5250 | 1.7 mg (within ASTM 5250 requirements for powder-free, which is |
§ 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.