(56 days)
First Glove 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.
First Glove Blue Nitrile Examination Gloves Powder Free are equivalent to Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, finger textured, ambidextrous with beaded cuff and single use only.
This document describes the acceptance criteria and performance of the "First Glove Blue Nitrile Examination Gloves Powder Free" based on non-clinical testing.
Here's the information requested:
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Subject Device K230958) |
|---|---|---|---|
| Dimensions - Length | ASTM D6319-19 | XS: ≥ 220 mm, S: ≥ 220 mm, M: ≥ 230 mm, L: ≥ 230 mm, XL: ≥ 230 mm, XXL: ≥ 230 mm | XS: 247.00 mm, S: 247.23 mm, M: 252.54 mm, L: 250.92 mm, XL: 245.54 mm, XXL: 251.00 mm |
| Dimensions - Width | ASTM D6319-19 | XS: 70±10 mm, S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm, XXL: 130±10 mm | XS: 74.31 mm, S: 85.08 mm, M: 94.85 mm, L: 105.38 mm, XL: 110.77 mm, XXL: 121.31 mm |
| Thickness | ASTM D6319-19 | Palm: ≥ 0.05 mm, Finger: ≥ 0.05 mm (for all sizes) | Palm: XS 0.07, S 0.06, M 0.07, L 0.06, XL 0.07, XXL 0.07 (mm); Finger: XS 0.10, S 0.10, M 0.10, L 0.10, XL 0.11, XXL 0.10 (mm) |
| Physical Properties - Tensile Strength (Before Ageing) | ASTM D6319-19 | ≥ 14 MPa (for all sizes) | XS: 35.25 MPa, S: 29.47 MPa, M: 27.72 MPa, L: 30.12 MPa, XL: 36.26 MPa, XXL: 33.60 MPa |
| Physical Properties - Tensile Strength (After Ageing) | ASTM D6319-19 | ≥ 14 MPa (for all sizes) | XS: 35.75 MPa, S: 30.02 MPa, M: 28.75 MPa, L: 29.55 MPa, XL: 31.20 MPa, XXL: 35.66 MPa |
| Physical Properties - Ultimate Elongation (Before Ageing) | ASTM D6319-19 | ≥ 500% (for all sizes) | XS: 537%, S: 525%, M: 525%, L: 523%, XL: 528%, XXL: 533% |
| Physical Properties - Ultimate Elongation (After Ageing) | ASTM D6319-19 | ≥ 400% (for all sizes) | XS: 493%, S: 478%, M: 516%, L: 495%, XL: 485%, XXL: 502% |
| Freedom from Holes | ASTM D5151-19 | AQL 2.5 | Passes AQL 2.5 |
| Powder Free Residue | ASTM D6124-06 (Reapproved 2017) | ≤ 2 mg/glove | XS: 0.04 mg/glove, S: 0.28 mg/glove, M: 0.04 mg/glove, L: 0.04 mg/glove, XL: 0.26 mg/glove, XXL: 0.48 mg/glove |
| Biocompatibility - Primary Skin Irritation | ANSI AAMI ISO 10993-10:2010/(R)2014 | Not an irritant | Considered a non-irritant |
| Biocompatibility - Dermal Sensitization | ANSI AAMI ISO 10993-10:2010/(R)2014 | Not a sensitizer | Not considered to be a contact sensitizer |
| Biocompatibility - In vitro Cytotoxicity | ANSI AAMI ISO 10993-5:2009/(R)2014 | Non-cytotoxic | Cytotoxic at extract concentrations of 100%, 66.7%, 44.4%, 29.6% and 19.8%; non-cytotoxic at 13.2% |
| Biocompatibility - Acute Systemic Toxicity | ANSI AAMI ISO 10993-11:2017 | Device extracts do not pose a systemic toxicity concern | Did not induce any systemic toxicity |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, etc.). However, it indicates the tests were conducted according to the specified ASTM and ISO standards, which typically include defined sampling plans.
The data provenance is from non-clinical bench testing. The country of origin of the data is not explicitly stated in the provided text, but the applicant's address is Malaysia (First Glove Sdn. Bhd.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation is based on non-clinical, objective laboratory tests against established international standards (ASTM and ISO). There were no human expert assessments of images or patient data to establish ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
None. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments. This submission relies on objective physical, chemical, and biological tests.
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. This is a submission for medical gloves, which are physical devices. MRMC comparative effectiveness studies are used for AI-powered diagnostic or interpretive tools, not for devices like gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests is based on the objective and quantifiable criteria defined by the relevant ASTM and ISO international standards. For example, for tensile strength, the ground truth is a specific numerical value (e.g., ≥ 14 MPa). For biocompatibility, it's defined by biological endpoints (e.g., "non-irritant," "non-sensitizer," "non-cytotoxic").
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As mentioned above, there is no training set for this type of device.
§ 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.