(34 days)
The Powder Free Latex Examination Gloves, Sterile 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.
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141. The difference in this submission is: - To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been established". The device remains no change in product design and the additional claim does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.
This 510(k) summary describes a Powder Free Latex Examination Glove, Sterile with Protein Content Labeling Claim. The submission seeks to include protein content labeling claims on the existing device, which was previously cleared under 510(k) K944141. The core device design and intended use remain unchanged.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets ( |
§ 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.