(89 days)
The Disposable Medical Nitrile gloves intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are composed of Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and blue colorant Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and a rolled rim at the cuff edge.
The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The document provided is a 510(k) summary for Disposable Medical Nitrile gloves (K213851) and thus describes non-clinical performance testing rather than a study for an AI-powered device. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted from the provided text, focused on the acceptance criteria and the tests performed for the Disposable Medical Nitrile gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance (All three lots: 20210825B, 20210827A, 20210830A) | Conclusion |
|---|---|---|---|
| ASMT D6319-19 - Physical Dimensions (Width) | S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | S: 83-86mm (Lot B), 83-85mm (Lot A), 83-85mm (Lot A); M: 91-92mm (Lot B), 91-93mm (Lot A), 90-92mm (Lot A); L: 104-106mm (Lot B), 104-106mm (Lot A), 104-106mm (Lot A); XL: 112-114mm (Lot B), 111-113mm (Lot A), 112-115mm (Lot A) | Passed |
| ASMT D6319-19 - Physical Dimensions (Length) | S: ≥220 mm; M/L/XL: ≥230 mm | S: 234-236mm; M: 235-237mm; L: 237-239mm (Lot B,A), 237-240mm (Lot A); XL: 237-239mm | Passed |
| ASMT D6319-19 - Physical Dimensions (Thickness) | Finger: ≥0.05mm; Palm: ≥0.05mm | Finger: S/M: Pass at 0.11mm (Lot B, A), S/M/L: Pass at 0.11mm (Lot A), L/XL: Pass at 0.12mm (Lot B), M/L/XL: Pass at 0.12mm (Lot A), XL: Pass at 0.12mm (Lot A); Palm: S/M/L/XL: Pass at 0.08mm | Passed |
| ASMT D6319-19 - Physical Properties (Before Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥500% | Passed |
| ASMT D6319-19 - Physical Properties (After Aging) | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Tensile Strength: ≥14Mpa; Ultimate Elongation: ≥400% | Passed |
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes | AQL 2.5 | Pass at AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) - 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.