(199 days)
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.
Here's a summary of the acceptance criteria and the study details for the Safeskin Hypoallergenic Powder-Free Nitrile Examination Gloves, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| ASTM D3578-91 | Compliance with dimensional measurement requirements (thickness, etc.), except for pre-aged ultimate elongation. | Applicant glove and K932404 comply. |
| ASTM D5250-92 | Far exceed requirements for synthetic (non-natural latex) examination gloves. | Applicant glove far exceeds requirements. |
| FDA Water Leak Test | No leaks with 1,000 mL of water within a two-minute period. Sampling per Mil Std. 105E or increased tightness. | Applicant glove and K932404 meet this requirement. |
| Powder-Free Assessment | (No specific FDA/ASTM standards set, but comparison to predicate device is key) | |
| Residue Weight | ≤ 2 mg (internal benchmark, compared to predicate) | Same as predicate (K932404), very low particulate levels. |
| Iodine Assay (Cornstarch) |
§ 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.