(80 days)
The Powder Free Latex Examination Glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on hands or finger(s) for medical purposes to provide a barrier.against potentially infectious materials and other contaminants.
The Powder Free Latex Examination Gloves. Natural or Blue Colour and with Protein Content Labeling Claim is equivalent to the exiting model, i.e. Latex Patient Examination Gloves. Powder Free which had submitted and cleared under 510(k) number K924356.
The differences in this submission are:
- With or without colour additive upon customers` preference or request. a)
- With protein content labeling claim, i.e. "This latex glove contains 50 micrograms or b) less of total water extractable protein per gram``.
The provided document is a 510(k) summary for a medical device: "Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 Micrograms or Less)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, many of the typical clinical study criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or not detailed in this type of regulatory filing.
The acceptance criteria are primarily based on established ASTM standards and FDA regulations for patient examination gloves. The "study" proving the device meets these criteria is a series of tests against these standards.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance | Outcome |
|---|---|---|---|
| Palm Width (Medium) | ASTM D 3578 | 91 - 92 mm | Meets |
| Length (Medium) | ASTM D 3578 | 285 - 292 mm | Meets |
| Finger Thickness (Medium) | ASTM D 3578 | 0.38 - 0.40 mm | Meets |
| Palm Thickness (Medium) | ASTM D 3578 | 0.35 - 0.37 mm | Meets |
| Tensile Strength (Unaged) | ASTM D 3578 | 22.88 - 30.87 MPa | Meets |
| Tensile Strength (Aged) | ASTM D 3578 | 21.05 - 27.60 MPa | Meets |
| Freedom from pinholes | ASTM D 3578 & FDA 21 CFR 800.20 (Acceptable Quality Level 1.5) | 0/125 (meaning 0 failures out of 125 tested, which meets 1/125) | Meets |
| Visual Inspection - Major defects | In-House Specification (AQL 2.5) | 1/125 | Meets |
| Visual Inspection - Minor defects | In-House Specification (AQL 4.0) | 1/125 | Meets |
| Powder Residual | ASTM D 3578 & ASTM D 6124 ( |
§ 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.