(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 glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: POWDER FREE GREEN COLOR SYNTHETIC EXAM GLOVES (also referred to as Non-Sterile Powder Free Purple Latex Examination Glove with Blueberry Scented and Protein Content Labeling Claim)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | Width (X-Small, Small, Medium, Large) | ASTM D3578-99: +/- 10mm (e.g., 70 +/- 10mm for X-Small) | SGMP: Within specified ranges (e.g., 70-75mm for X-Small) |
| Length | 230mm minimum for all sizes | SGMP: 242mm | |
| Thickness - Finger | 0.08mm min | SGMP: 0.08mm min | |
| Thickness - Palm | 0.08mm min | SGMP: 0.08mm min | |
| Physical Properties | Tensile Strength (Before Aging) | ASTM-D3578-00: 14.0 Mpa | SGMP: 25.3, 26.0, 28.9, 22.0 Mpa (for X-Small, Small, Medium, Large respectively) |
| Ultimate Elongation (Before Aging) | ASTM-D3578-00: 700% | SGMP: 840, 850, 860, 840 % (for X-Small, Small, Medium, Large respectively) | |
| Tensile Strength (After Aging) | ASTM-D3578-00: 14.0 Mpa | SGMP: 21.3, 23.4, 23.6, 21.7 Mpa (for X-Small, Small, Medium, Large respectively) | |
| Ultimate Elongation (After Aging) | ASTM-D3578-00: 500% | SGMP: 890, 930, 940, 900 % (for X-Small, Small, Medium, Large respectively) | |
| Water Tight Test | Leakage (AQL) | 2.5% AQL (FDA/ASTM D3578-00 requirements) | SGMP: Leaked Status with counts of 0-2 (e.g., 2 for un-aged X-Small, 0 for un-aged Small) – "The above figures are within the gloves of 2.5% AQL." |
| Biocompatibility | General Biocompatibility | Pass relevant tests for examination gloves | SGMP: Passed the tests (as per Appendix L, not provided here) |
| Powder Content | Residual Powder Content (ASTM D 6124-00) | 2 mg/glove max (FDA Internal Requirement) | SGMP: Range: 0.6-1.2 mg/glove; Mean: 0.9 mg/glove |
| Presence of Cornstarch | Negative (FDA Internal Requirement) | SGMP: Negative | |
| Protein Level | Residual Protein Level (ASTM D 5712-95) |
§ 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.