(185 days)
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
The provided document is a 510(k) summary for a medical device: "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color". This summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets acceptance criteria through a specific study with AI or human readers. Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as it does not describe an AI/software study.
However, the document does contain "Acceptance Criteria" and "Result" for various non-clinical performance and biocompatibility tests.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Characteristic) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-2019 (Length) | To determine the length of the gloves | Min 220 mm for X-small and Small sizes; Min 230 mm for other sizes | X-Small: 303 mm; Small: 304 mm; Medium: 305mm; Large: 306mm; X-Large: 307mm |
| 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: 74 mm; Small: 84 mm; Medium: 94 mm; Large: 104 mm; X-Large: 115 mm |
| ASTM D6319-2019 (Thickness) | To determine the thickness of the gloves | Palm 0.05 mm min; Finger 0.05 mm min for all sizes | All sizes: Palm 0.10mm; Finger 0.12mm |
| ASTM D6319-2019 (Tensile Strength - Before Ageing) | To Determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14Mpa Min for all sizes | X-Small: 18.44Mpa; Small: 18.49Mpa; Medium: 18.56Mpa; Large: 18.62Mpa; X-Large: 18.64Mpa |
| ASTM D6319-2019 (Tensile Strength - After Ageing) | To Determine the physical properties- Tensile strength | After Ageing Tensile Strength 14Mpa Min for all sizes | X-Small: 17.49Mpa; Small: 17.53Mpa; Medium: 17.65Mpa; Large: 17.71Mpa; X-Large: 17.76Mpa |
| ASTM D6319-2019 (Ultimate Elongation - Before Ageing) | To Determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% Min for all sizes | X-Small: 683%; Small: 687%; Medium: 692%; Large: 695%; X-Large: 698% |
| ASTM D6319-2019 (Ultimate Elongation - After Ageing) | To Determine the physical properties- Ultimate Elongation | After Ageing Ultimate Elongation 400% Min for all sizes | X-Small: 656%; Small: 660%; Medium: 663%; Large: 666%; X-Large: 669% |
| ASTM D5151-2019 (Water Tight / Holes) | To determine the holes in the gloves | AQL 2.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder) | To determine the residual powder in the gloves | 2 Mg/Glove Max | All sizes: 0.21mg/glove (X-small, Small), 0.22 mg/glove (Medium, Large, X-Large) |
| ISO 10993-10 (Skin Irritation) | To determine the potential of the material under test to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 (Skin Sensitization) | To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 (In vitro cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. (Note: This result does not meet the acceptance criteria. The document states "Under the conditions of the study cytotoxic" against an acceptance criteria of "Under the conditions of study non cytotoxic". This could be a typo in the provided text as later in the conclusion it says it performs "as well as or better than" in some cases. However, strictly based on the table, it appears unmet.) |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential of the test item extracts (both inside and outer surfaces) 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 |
| Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41 | To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. |
| Bacterial Endotoxin test USP 42 | To determine the bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves | , USP 42). The purpose of these tests was to demonstrate the device's physical properties (length, width, thickness, tensile strength, elongation), integrity (water tightness/holes), chemical residues (powder content), and biological safety (skin irritation, skin sensitization, cytotoxicity, systemic toxicity, pyrogenicity, bacterial endotoxin). |
The results of these tests, as presented in the "Device Performance" columns, were compared against the "Acceptance Criteria" specified by the respective standards. The document states that the device met these criteria for most tests, demonstrating its safety and effectiveness. Notably, for "In vitro cytotoxicity," the device's result was "cytotoxic" while the acceptance criteria was "non cytotoxic." Despite this, the overall conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device K171093." This suggests either an interpretation allowing for some cytotoxicity in the context of the device's use and predicate equivalence, or a potential inconsistency in the provided information.
§ 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.