(37 days)
The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (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 mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (ASTM D3578-01aE2 or FDA/Internal Requirements) | Reported Device Performance (SGMP / Lot# 4144) |
|---|---|---|
| Dimension | ||
| X-Small Width | 70 mm +/- 10 mm | 70 – 80 mm |
| Small Width | 80 mm +/- 10 mm | 80 – 85 mm |
| Medium Width | 95 mm +/- 10 mm | 90 – 97 mm |
| Large Width | 111 mm +/- 10 mm | 105 - 111 mm |
| Length (all sizes) | 230 mm minimum | 242 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Thickness - Palm | 0.08 mm min | 0.1 mm min |
| Physical Properties | ||
| Ten. Strength Before Aging | 18.0 Mpa | X-Small: 23.5 Mpa; Small: 26.8 Mpa; Medium: 22.5 Mpa; Large: 29.2 Mpa |
| Ult. Elong. Before Aging | 650 % | X-Small: 890 %; Small: 800 %; Medium: 850 %; Large: 870 % |
| Ten. Strength After Aging | 14.0 Mpa | X-Small: 22.8 Mpa; Small: 27.5 Mpa; Medium: 28.3 Mpa; Large: 26.8 Mpa |
| Ult. Elong. After Aging | 500 % | X-Small: 780 %; Small: 820 %; Medium: 750 %; Large: 820 % |
| Water Tight Test | ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL (Acceptance Quality Limit) | Un-aged (X-Small: 0, Small: 1, Medium: 2, Large: 0 leaks); Aged (X-Small: 0, Small: 1, Medium: 1, Large: 2 leaks) - All within 2.5% AQL |
| Biocompatibility | Passed tests for examination gloves (as per APPENDIX K) | Passed (results as per APPENDIX K) |
| Residual Powder Content | FDA Requirement: 2 mg/glove max (ASTM D 6124-00) | Range: 0.4 - 1.0 mg/glove; Mean: 0.8 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.