(34 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, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the SGMP Company Ltd. latex examination gloves, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Criteria (ASTM D3578-01aE2 or FDA Internal) | Reported Device Performance (SGMP) |
|---|---|---|---|
| Dimensions | X-Small (width) | 70 mm +/- 10 mm | 70 - 75 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 | 0.08 mm min | |
| Thickness - Palm | 0.08 mm min | 0.08 mm min | |
| Physical Properties (Before Aging) | Tensile Strength | 14.0 Mpa | 22.0 - 30.2 Mpa (depending on size) |
| Ultimate Elongation | 700 % | 800 - 900 % (depending on size) | |
| Physical Properties (After Aging) | Tensile Strength | 14.0 Mpa | 24.6 - 28.3 Mpa (depending on size) |
| Ultimate Elongation | 500 % | 800 - 830 % (depending on size) | |
| Water Tight Test (Leakage) | Acceptable Quality Level (AQL) | 2.5% AQL (implied from FDA pinhole requirements) | Within 2.5% AQL (1-4 leaks out of 500 total tested) |
| Biocompatibility | General Biocompatibility | Passed tests for examination gloves (specifics not listed) | Passed the tests for examination gloves |
| Residual Powder Content | Residual Powder Content | 2 mg/glove max (FDA internal requirement) | Range: 0.5-0.9 mg/glove, Mean: 0.7 mg/glove |
| Presence of Cornstarch | Negative | Negative | |
| Residual Protein Level | Latex Protein Level (ASTM D 5712-99) |
§ 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.