(252 days)
The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
The provided text describes the acceptance criteria and performance data for "Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim."
Here's the information parsed according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Latex | Latex |
| Cuff | Beaded | Beaded |
| Powder Residue | Maximum 2mg/glove | In compliance with ASTM D3578-10 |
| Quality Assurance | ISO 2859-1:1999, ISO 9001:2000, ISO 13485 | Manufactured under ISO9001:2000 and ISO 13485 (implicitly meets ISO 2859-1:1999 as per ASTM) |
| Dimensions | Inspection Level S-2, AQL 4.0 | (Implicitly met as per ASTM D3578-10 compliance) |
| Overall Length | 240 mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Width (medium glove) | 95 mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Thickness | 0.08mm minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Physical Properties | Inspection Level S-2, AQL 4.0 | (Implicitly met as per ASTM D3578-10 compliance) |
| Before Aging-Tensile Strength | 18.0 Mpa minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Before Aging-Ultimate Elongation | 650% minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| After Aging-Tensile Strength | 14.0 Mpa minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| After Aging-Ultimate Elongation | 500% minimum | (Implicitly met as per ASTM D3578-10 compliance) |
| Water Tight Test 1000ml | Inspection Level G-1, AQL 1.5 | Meets the FDA 1000 ml water test both before and after aging |
| Visual Major Defects | Inspection Level G-1, AQL 1.5 | (Implicitly met as per ASTM D3578-10 compliance) |
| Visual Minor Defects | Inspection Level G-1, AQL 2.5 | (Implicitly met as per ASTM D3578-10 compliance) |
| Protein Content |
§ 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.