(28 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, powder free and meeting all the requirements of ASTM-D3578-00 Standard Specification for Latex Examination Gloves for Medical Application.
The provided document describes the acceptance criteria and the results of a study for "Non-Sterile Powder Free Vanilla Scented Latex Examination Gloves".
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria (ASTM-D3578-00 or FDA/SGMP requirements) and the device’s reported performance (SGMP's actual measurements or compliance statements).
| Criteria Category | Acceptance Criteria | Reported Device Performance (SGMP) |
|---|---|---|
| Dimensions (Width - X-Small) | 70 mm +/- 10 mm | 70 - 75 mm |
| Dimensions (Width - Small) | 80 mm +/- 10mm | 80 - 85 mm |
| Dimensions (Width - Medium) | 95 mm +/- 10mm | 90 - 97 mm |
| Dimensions (Width - Large) | 111mm +/- 10mm | 105 - 111 mm |
| Dimensions (Length - All) | 230 mm minimum | 252 mm |
| Dimensions (Thickness - Finger) | 0.08 mm min | 0.08 mm min |
| Dimensions (Thickness - Palm) | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | 14.0 Mpa (min) | X-S: 26.6, S: 27.5, M: 23.2, L: 25.7 Mpa (all > 14.0) |
| Ultimate Elongation (Before Aging) | 700 % (min) | X-S: 870, S: 870, M: 840, L: 860 % (all > 700) |
| Tensile Strength (After Aging) | 14.0 Mpa (min) | X-S: 21.8, S: 26.6, M: 23.7, L: 24.4 Mpa (all > 14.0) |
| Ultimate Elongation (After Aging) | 500 % (min) | X-S: 870, S: 950, M: 910, L: 910 % (all > 500) |
| Water Tight Test (AQL) | 2.5% AQL (FDA/ASTM D3578-00) | Un-aged: X-S (1/125), S (2/125), M (0/125), L (2/125) |
| Aged: X-S (0/125), S (1/125), M (1/125), L (1/125). All within 2.5% AQL. | ||
| Biocompatibility | Passed tests for examination gloves (implicit) | Passed tests (per Appendix L) |
| Residual Powder Content | 2 mg/glove max (FDA Internal) | Mean: 1.2 mg/glove (Range: 0.8-1.6 mg/glove) |
| Presence of Cornstarch | Negative (FDA Internal) | 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.