(132 days)
DAIYANG 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.
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
The provided document is a 510(k) summary for the "DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance (DAIYANG Powder Free Vinyl Patient Examination Gloves) | Predicate Device Performance (K091663) | Result of Comparison (DAIYANG vs. Predicate) |
|---|---|---|---|---|
| Dimension: | ASTM D 5250-06(Reapproved 2011) | Meets ASTM D5250-06 | Similar | |
| Length | ≥230mm | 231-241mm | 232-240mm | Similar |
| Width (Small) | 80-90 mm | 81-89 | 81-87 | Similar |
| Width (Medium) | 90-100mm | 93-99 | 93-98 | Similar |
| Width (Large) | 100-110mm | 102-110 | 102-109 | Similar |
| Width (X Large) | 110-120 mm | 111-1119 (likely typo, should be 111-119) | 113-118 | Similar |
| Thickness (Fingertip) | ≥0.05mm | 0.05-0.10 | 0.08-0.11 | Similar |
| Thickness (Palm) | ≥0.08mm | 0.09-0.13 | 0.10-0.12 | Similar |
| Physical Properties: | ASTM D 5250-06(Reapproved 2011) | Before aging/after aging: Elongation ≥300%, Tensile Strength ≥ 14MPa | Similar | |
| Tensile strength | ≥11MPa (Before & After aging) | 15-25 MPa | 15-20 MPa | Similar |
| Elongation rate | ≥300% (Before & After aging) | 340-410% | 350-420% | Similar |
| Freedom from pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06; ASTM D5151-06 | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Similar |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and 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.