(121 days)
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text describes the acceptance criteria and performance data for the "Penta Glove," a Blue Nitrile Examination Glove. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a de novo approval process.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|
| ASTM D6319-2019 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 246 mm, Small: 246 mm, Medium: 248 mm, Large: 248 mm, X-Large: 250 mm | Meets criteria |
| ASTM D6319-2019 (Width) | To determine the width of the gloves | X-small: 70±10 mm, Small: 80±10 mm, Medium: 95±10 mm, Large: 110±10 mm, X-Large: 120±10 mm | X-small: 68 mm, Small: 80 mm, Medium: 92 mm, Large: 105 mm, X-Large: 115 mm | Meets criteria (all reported values are within the +/-10mm range of the nominal size criteria) |
| ASTM D6319-2019 (Thickness) | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | X-Small: 0.12mm (Palm), 0.20mm (Finger); Small: 0.12mm (Palm), 0.20mm (Finger); Medium: 0.12mm (Palm), 0.20mm (Finger); Large: 0.12mm (Palm), 0.20mm (Finger); X-Large: 0.12mm (Palm), 0.20mm (Finger) | Meets criteria |
| ASTM D6319-2019 (Physical Properties - Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: 14 Mpa Min for all sizes; After Ageing: 14 Mpa Min for all sizes | Before Ageing: X-Small 18.45 Mpa, Small 18.54 Mpa, Medium 18.62 Mpa, Large 18.67 Mpa, X-Large 18.72 Mpa; After Ageing: X-Small 17.54 Mpa, Small 17.56 Mpa, Medium 17.68 Mpa, Large 17.75 Mpa, X-Large 17.80 Mpa | Meets criteria (all reported values are above 14 Mpa) |
| ASTM D6319-2019 (Physical Properties - Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: 500% Min for all sizes; After Ageing: 400% Min for all sizes | Before Ageing: X-Small 686%, Small 690%, Medium 694%, Large 702%, X-Large 705%; After Ageing: X-Small 659%, Small 665%, Medium 668%, Large 670%, X-Large 674% | Meets criteria (all reported values are above the minimums) |
| ASTM D5151-2019 (Water Tight / Holes) | To determine the holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | Meets criteria |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder) | To determine the residual powder in the gloves | 2 Mg/Glove Max | X-small: 0.21mg/glove, Small: 0.21mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove | Meets criteria |
| ISO 10993-10 (Primary Skin Irritation) | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant | Meets criteria |
| ISO 10993-10 (Dermal Sensitization) | To determine the skin sensitization potential of the material in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Meets criteria |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. | Does Not Meet Criteria (Reported as "cytotoxic" against a "non cytotoxic" acceptance criteria, though in the previous F. Summary of Technological Characteristics, it was listed as "Same" as predicate with predicate also being "cytotoxic"). This discrepancy needs clarification. |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Meets criteria |
| USP 42 (Bacterial Endotoxin) | To determine the Bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves |
§ 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.