(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 BLUE COLORED POWDERED LATEX EXAMINATION GLOVES. This document does not pertain to an AI-powered device or software for medical imaging analysis. Therefore, many of the requested points, such as those related to AI effectiveness, ground truth establishment for AI, expert qualifications, and training/test sets for algorithms, are not applicable.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from ASTM-D3578-99 unless otherwise noted) | Reported Device Performance (Shield Gloves) |
|---|---|---|
| Dimensions | ||
| Width (Ambidextrous) | X-Small: 70 mm +/- 10 mm | |
| Small: 80 mm +/- 10 mm | ||
| Medium: 95 mm +/- 10 mm | ||
| Large: 111 mm +/- 10 mm | ||
| Width (Size Fitted) | 5.5: 70 +/- 10 mm | |
| 6.0: 76 +/- 10 mm | ||
| 6.5: 83 +/- 10 mm | ||
| 7.0: 89 +/- 10 mm | ||
| 7.5: 95 +/- 10 mm | ||
| 8.0: 102 +/- 10 mm | ||
| 8.5: 108 +/- 10 mm | ||
| 9.0: 114 +/- 10 mm | ||
| Length | 230 mm min | 230 mm (implied to meet or exceed) |
| 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 MPa min | Shield: 27.7 MPa, 25.2 MPa, 29.1 MPa (all meet/exceed) |
| Tensile Strength (Unaged) | 14.0 MPa min | Shield: 24.3 MPa, 30.3 MPa, 30.1 MPa (all meet/exceed) |
| Ultimate Elongation (Aged) | 500% min | Shield: 950%, 900%, 950% (all meet/exceed) |
| Ultimate Elongation (Unaged) | 700% min | Shield: 900%, 900%, 900% (all meet/exceed) |
| Watertightness | 2.5% AQL (Acceptable Quality Level) | Batch 9028-9035 S: 4 leaks out of 315 samples (1.27%) |
| Batch 9030-9036 M: 7 leaks out of 315 samples (2.22%) | ||
| Batch 9027-9031 L: 3 leaks out of 200 samples (1.5%) | ||
| (All within 2.5% AQL requirement) | ||
| Biocompatibility | Not a primary irritant | |
| Not a sensitizer | Primary Dermal Irritation Test: Not a primary irritant | |
| Skin Sensitization Study: Not a sensitiser | ||
| Residual Protein Level |
§ 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.