(55 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance data for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES, rather than a typical AI-driven device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, etc.) are not applicable to the documentation provided for this type of medical device clearance.
However, I can extract the relevant information regarding acceptance criteria and reported performance from the document.
Acceptance Criteria and Reported Device Performance for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Characteristic | Acceptance Criteria (ASTM-D3578-99 / FDA) | Reported Device Performance |
|---|---|---|---|
| Dimension | Width (X-Small) | 70 mm +/- 10 mm | 70 mm +/- 10 mm |
| Width (Small) | 80 mm +/- 10 mm | 80 mm +/- 10 mm | |
| Width (Medium) | 95 mm +/- 10 mm | 95 mm +/- 10 mm | |
| Width (Large) | 111 mm +/- 10 mm | 111 mm +/- 10 mm | |
| Width (Size 5.5) | 70 +/- 10 mm | 70 +/- 10 mm | |
| Width (Size 6.0) | 76 +/- 10 mm | 76 +/- 10 mm | |
| Width (Size 6.5) | 83 +/- 10 mm | 83 +/- 10 mm | |
| Width (Size 7.0) | 89 +/- 10 mm | 89 +/- 10 mm | |
| Width (Size 7.5) | 95 +/- 10 mm | 95 +/- 10 mm | |
| Width (Size 8.0) | 102 +/- 10 mm | 102 +/- 10 mm | |
| Width (Size 8.5) | 108 +/- 10 mm | 108 +/- 10 mm | |
| Width (Size 9.0) | 114 +/- 10 mm | 114 +/- 10 mm | |
| Length | 230 mm | 230 mm | |
| Thickness - Finger | 0.08 mm min | 0.08 mm min | |
| Thickness - Palm | 0.08 mm min | 0.08 mm min | |
| Physical Properties | Tensile Strength (Aged) | 14.0 | 21.8 - 27.3 |
| (ASTM-D3578-99) | Tensile Strength (Unaged) | 14.0 | 25.1 - 27.3 |
| Ultimate Elongation (Aged) | 500 | 877 - 975 | |
| Ultimate Elongation (Unaged) | 700 | 790 - 922 | |
| Water Leak Test | AQL | 2.5% |
§ 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.