(109 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min
The provided document describes the acceptance criteria and performance of the Powder-Free Clear Vinyl Patient Examination Gloves by Zibo Yue Fan Medical Products Co., Ltd. against a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are defined by compliance with ASTM standards and key physical properties. The "reported device performance" reflects the measured values for the subject device and the predicate device.
| Device Characteristics / Acceptance Criteria | Proposed Device (Reported Performance) | Predicate Device (Reported Performance) | Comparison Conclusion |
|---|---|---|---|
| Product Name | Powder Free Clear Vinyl Patient Examination Glove | Powder free PVC Vinyl Exam Gloves | |
| Product Code | LYZ | LYZ | Same |
| Intended Use (Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination) | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Regulation Number (21 CFR 880.6250) | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Sizes | Small, Medium, Large, Extra-Large | Small, Medium, Large, Extra-Large | Same |
| Length on Large Size (ASTM-D-5250-06 requirement: 230mm min) | Average over 232.23mm (Meets) | Average over 230mm (Meets) | Similar |
| Width of Palm on Large Size (ASTM-D-5250-06 general requirement for width for size Large: 94mm min, see page 4 for subject device spec) | Average 95mm (Meets) | Average 95mm (Meets) | Similar |
| Palm Thickness (ASTM-D-5250-06 general requirement: 0.09 mm min, see page 4 for subject device spec) | Average 0.095 mm (Meets) | Average 0.095 mm (Meets) | Similar |
| Fingertip Thickness (ASTM-D-5250-06 general requirement: 0.086 mm min, see page 4 for subject device spec) | Average 0.09 mm (Meets) | Average 0.09 mm (Meets) | Similar |
| Residual Powder (ASTM D6124-06 Standard Test Method, |
§ 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.