(83 days)
The Powder-Free Black Examination Glove 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.
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger)
Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end)
BEFORE AGING Tensile Strength: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
The provided document describes the acceptance criteria and performance of a Powder-Free Black Latex Examination Glove. It does not describe a study involving an AI-powered device or human readers. Therefore, several requested sections, such as those pertaining to AI model performance, human expert involvement, and training/test set details, are not applicable.
Here's the available information presented in the requested format:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Minimum/Maximum) | Reported Device Performance |
|---|---|---|
| Physical Properties | Meets all requirements of ASTM D3578-05 | Meets all requirements of ASTM D3578-05 |
| Powder Residue | Maximum 2 mg/glove | Not explicitly stated, but "Powder-Free" implies meeting this or better. |
| Overall Length | 240 mm minimum | 240 mm minimum |
| Width (for medium glove) | 95 mm minimum | 95 mm minimum |
| Palm Thickness | 0.13 to 0.18 mm (at center of palm) | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness | 0.15 to 0.20 mm (at 15mm from tip of center finger) | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness | 0.10 to 0.15 mm (at 40mm from the beaded end) | 0.10 to 0.15 mm (at 40mm from the beaded end) |
| Before Aging | ||
| Tensile Strength | 21.0 Mpa minimum | 21.0 Mpa minimum |
| Ultimate Elongation | 700% minimum | 700% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| After Aging | ||
| Tensile Strength | 16.0 Mpa minimum | 16.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| Water Tightness | Meets FDA 1000 ml water test (both before and after aging) | Meets FDA 1000 ml water test (both before and after aging) |
| Protein Labeling Claim |
§ 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.