(88 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
This looks like a 510(k) premarket notification for patient examination gloves, which are Class I medical devices. For these types of devices, the regulatory approval heavily relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than a clinical effectiveness study of the kind you might see for an AI diagnostic device.
Therefore, many of the questions you've asked (about AI assistance, ground truth, expert opinions for labelling, effect size, etc.) are not applicable to this document as it describes a physical, non-AI medical device (gloves).
However, I can extract the relevant information regarding acceptance criteria and the study (testing) used to prove the device met those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06(Reapproved 2011) | Meets |
| - Length | ≥ 230mm min (from ASTM D5250-06) | 230mm min for all sizes |
| - Width (Small) | 80-90 mm (from ASTM D5250-06) | 80-85 mm |
| - Width (Medium) | 90-100 mm (from ASTM D5250-06) | 94-100 mm |
| - Width (Large) | 100-110 mm (from ASTM D5250-06) | 102-108 mm |
| - Width (X Large) | 110-120 mm (from ASTM D5250-06) | 113-116 mm |
| Physical Properties | ASTM standard D 5250-06(Reapproved 2011) | Meets |
| - Elongation (Before/After aging) | ≥ 300% (from ASTM D5250-06) | 390-420% |
| - Tensile Strength (Before/After aging) | ≥ 14MPa (from ASTM D5250-06) | 15-20 MPa |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D 5250-06(Reapproved 2011), ASTM D 5151-06(Reapproved 2011) | Meets, Holes at Inspection Level I AQL 2.5 (per ASTM D5151-06) |
| Powder Residual | ASTM D 5250-06 (Reapproved 2011) & D6124-06 (Reaffirmation 2011) | 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.