(213 days)
The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less) 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.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and the study conducted for "Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less)."
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (ASTM D3578-05) | Reported Device Performance (SGMP) | Pass/Fail |
|---|---|---|---|
| Dimension | |||
| X-Small (Width) | 70 mm +/- 10 mm | 70 - 80 mm | Pass |
| Small (Width) | 80 mm +/- 10 mm | 80 - 85 mm | Pass |
| Medium (Width) | 95 mm +/- 10 mm | 90 - 97 mm | Pass |
| Large (Width) | 111 mm +/- 10 mm | 105 - 111 mm | Pass |
| Length (all sizes) | 230 mm minimum | 240 mm | Pass |
| Thickness - Finger | 0.08 mm min | 0.13 mm min | Pass |
| Thickness - Palm | 0.08 mm min | 0.10 mm min | Pass |
| Physical Properties | |||
| Tensile Strength (Mpa) | |||
| Before Aging | 18.0 Mpa | X-Small: 23.5 Mpa | |
| Small: 28.8 Mpa | |||
| Medium: 22.7 Mpa | |||
| Large: 25.5 Mpa | Pass | ||
| After Aging | 14.0 Mpa | X-Small: 21.8 Mpa | |
| Small: 25.5 Mpa | |||
| Medium: 22.3 Mpa | |||
| Large: 23.8 Mpa | Pass | ||
| Ultimate Elongation (%) | |||
| Before Aging | 650 % | X-Small: 780 % | |
| Small: 920 % | |||
| Medium: 835 % | |||
| Large: 810 % | Pass | ||
| After Aging | 500 % | X-Small: 740 % | |
| Small: 850 % | |||
| Medium: 780 % | |||
| Large: 830 % | Pass | ||
| Water Tight Test | 2.5% AQL (max. 25 leaky gloves per 1000) | UN-AGED: 2-2-1-2 leaky gloves (total 7/500) | |
| AGED: 0-3-2-1 leaky gloves (total 6/500) | Pass | ||
| Total Residual Powder Content | 10 mg/dm² max (ASTM D 6124-06) | Range: 5.2 - 8.5 mg/dm² | |
| Mean: 7.5 mg/dm² | Pass | ||
| 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.