(366 days)
The Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, 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 with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim
Here's a breakdown of the acceptance criteria and the study information for the "Non-Sterile, Powder-Free, Latex Examination Gloves with Lanolin and Vitamin E Coating, Green and with Protein Labeling Claim," based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Minimum/Maximum) | Reported Device Performance |
|---|---|---|
| Material | Latex | Latex |
| Cuff | Beaded | Beaded |
| Powder Residue | 2mg/glove maximum | N/A (implied compliance) |
| Inspection Level: Dimensions | S-2, AQL 4.0 | N/A (implied compliance) |
| Inspection Level: Physical Properties | S-2, AQL 4.0 | N/A (implied compliance) |
| Inspection Level: Water Tight Test 1000ml | G-1, AQL 1.5 | N/A (implied compliance) |
| Inspection Level: Visual Major Defects | G-1, AQL 1.5 | N/A (implied compliance) |
| Inspection Level: Visual Minor Defects | G-1, AQL 2.5 | N/A (implied compliance) |
| Overall Length | 240 mm minimum | 240 mm minimum |
| Width (medium glove) | 95 mm minimum | 95 mm minimum |
| Thickness | 0.08 mm minimum | 0.08 mm minimum |
| Tensile Strength (Before Aging) | 18.0 Mpa minimum | 18.0 Mpa minimum |
| Ultimate Elongation (Before Aging) | 650% minimum | 650% minimum |
| Tensile Strength (After Aging) | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation (After Aging) | 500% minimum | 500% minimum |
| Special Properties | Lanolin and Vitamin E inner coating | Lanolin and Vitamin E inner coating |
| Protein Labeling Claim 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.