(58 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
This document is a 510(k) Premarket Notification summary for Powder Free Nitrile Patient Examination Gloves, Blue Color. It does not describe an AI medical device or a study involving human readers. Therefore, I cannot provide details on acceptance criteria or an AI-related study as described in your request.
The provided text details the submission of a medical device (nitrile examination gloves) for regulatory clearance. The core of the submission, and the content of the "Acceptance Criteria" table, relates to physical and chemical properties of the gloves, and biocompatibility, as tested against established ASTM and ISO standards.
Here's an analysis of the existing content in relation to your request, highlighting what's present and what's missing:
1. A table of acceptance criteria and the reported device performance
The provided text contains a comprehensive table on page 4 titled "Features & Description" which functions as the acceptance criteria and reported device performance.
| Features & Description | Acceptance Criteria (from Subject Device) | Reported Performance (from Subject Device) |
|---|---|---|
| Dimension - Length | ≥230mm min (from predicate guidance) | 232 mm min for all sizes |
| Dimension - Width | Small 75-90 mm, Medium 87-102 mm, Large 107-119mm, X large 114-128 mm | Measured values for each size fall within these ranges (implied by "Similar" and comparison to predicate values) |
| Dimension - Thickness | Fingertip ≥0.08mm min, Palm ≥0.08mm min | Fingertip 0.08mm min, Palm 0.08mm min (reported as "Similar" to predicate which implies meeting criteria) |
| Physical Properties - Tensile strength (Before & After aging) | ≥14MPa | Before Aging: 19-25 MPa; After Aging: 17-23 MPa |
| Physical Properties - Elongation (Before aging) | ≥500% | 560-610 % |
| Physical Properties - Elongation (After aging) | ≥400% | 460-570 % |
| Freedom from Pinholes (Water leakage test) | Inspection Level I, AQL2.5, Accept/Reject criteria of 10/11. 5 noncompliance is allowed. | Meets criteria (implied by "Similar" and no reported failure) |
| Residual Powder |
§ 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.