Search Results
Found 1 results
510(k) Data Aggregation
(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<151> | 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<85> | To determine the bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves | <20 EU/pair of gloves |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical and biocompatibility testing, not an AI/software study with a test set of data. The "test sets" here would refer to the number of gloves tested per batch or samples for biocompatibility - which is not specified in detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is established through standardized laboratory testing methods (e.g., ASTM D6319, ISO 10993 series) and their respective criteria. For instance, for physical properties, it's objective measurements based on the standard. For biocompatibility, it's the observed biological response in animal models or in vitro assays compared to established acceptable limits.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The device "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color" underwent a series of non-clinical performance and biocompatibility tests according to recognized international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP 41<151>, USP 42<85>). 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.
Ask a specific question about this device
Page 1 of 1