(120 days)
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), 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 examiner's hand or finger to prevent contamination between patient and examiner.
Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.
The provided document is a 510(k) premarket notification for "Non-Sterile, Powder-Free, Latex Examination Gloves" and does not describe a study involving an algorithm or AI. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets them in the context of AI/algorithm performance.
However, I can extract the acceptance criteria and reported performance for the latex examination gloves as presented in the document, which primarily focuses on physical and chemical properties of the gloves.
Here's the information based on the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (ASTM D3578-01a & FDA 1000ml water test) | Reported Device Performance |
|---|---|---|
| Physical Properties (Before Aging) | ||
| Tensile Strength | 21. Mpa minimum | Meets criteria |
| Ultimate Elongation | 700% minimum | Meets criteria |
| Pinhole AQL | 1.5 minimum | Meets criteria |
| Physical Properties (After Aging) | ||
| Tensile Strength | 16.0 Mpa minimum | Meets criteria |
| Ultimate Elongation | 500% minimum | Meets criteria |
| Pinhole AQL | 1.5 minimum | Meets criteria |
| Dimensions | ||
| Overall Length | 240 mm minimum | Meets criteria |
| Width (medium glove) | 95 mm minimum | Meets criteria |
| Palm Thickness | 0.13 to 0.18 mm | Meets criteria |
| Finger Thickness | 0.15 to 0.20 mm | Meets criteria |
| Cuff Thickness | 0.10 to 0.15 mm | Meets criteria |
| Biocompatibility | Pass tests for examination gloves | Passed the tests |
| Residual Protein 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.