(207 days)
The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (50 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.
This document describes the acceptance criteria and performance data for "Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (50 Micrograms or Less)" submitted by SGMP Company Limited.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578-05 Standard / FDA Requirement) | Reported Device Performance (SGMP) |
|---|---|---|
| Dimension (Width) | X-Small: 70 mm +/- 10 mm | 70 – 80 mm |
| Small: 80 mm +/- 10 mm | 80 – 85 mm | |
| Medium: 95 mm +/- 10 mm | 90 – 97 mm | |
| Large: 111 mm +/- 10 mm | 105 - 111 mm | |
| Dimension (Length) | 230 mm minimum (for all sizes) | 240 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Thickness - Palm | 0.08 mm min | 0.10 mm min |
| Tensile Strength (Before Aging) | 18.0 Mpa | X-Small: 25.1 Mpa |
| Small: 22.8 Mpa | ||
| Medium: 28.0 Mpa | ||
| Large: 26.3 Mpa | ||
| Tensile Strength (After Aging) | 14.0 Mpa | X-Small: 24.5 Mpa |
| Small: 23.5 Mpa | ||
| Medium: 26.0 Mpa | ||
| Large: 25.2 Mpa | ||
| Ultimate Elongation (Before Aging) | 650 % | X-Small: 830 % |
| Small: 870 % | ||
| Medium: 850 % | ||
| Large: 855 % | ||
| Ultimate Elongation (After Aging) | 500 % | X-Small: 790 % |
| Small: 805 % | ||
| Medium: 780 % | ||
| Large: 770 % | ||
| Water Tight Test (AQL) | 2.5% AQL (ASTM D3578-05 requirements) | Un-aged (Batch #7023): |
| X-Small: 0 leaked (0%) | ||
| Small: 2 leaked (1.6%) | ||
| Medium: 1 leaked (0.8%) | ||
| Large: 1 leaked (0.8%) | ||
| Aged (Batch #7023): | ||
| X-Small: 2 leaked (1.6%) | ||
| Small: 0 leaked (0%) | ||
| Medium: 1 leaked (0.8%) | ||
| Large: 0 leaked (0%) | ||
| All reported values are ≤ 2.5% | ||
| Biocompatibility | Passed tests for examination gloves (as per APPENDIX K) | Passed |
| Residual Powder Content | 10 mg/glove max (ASTM D 6124-06) | Ranger: 0.8-1.7 mg/glove |
| Mean: 1.4 mg/glove | ||
| Presence of Cornstarch | Negative | Negative |
| 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.