(141 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).
The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.
These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.
The document describes the acceptance criteria and the results of non-clinical testing for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics and Parameters | Standard | Acceptance Criteria | Proposed Device Performance (Result) |
|---|---|---|---|
| Residual Powder Content | ASTM D6124-06 (Reapproved 2017) | Less than 2mg / glove | XS: 0.36 mg/glove, S: 0.32 mg/glove, M: 0.36 mg/glove, L: 0.30 mg/glove, XL: 0.32 mg/glove, XXL: 0.30 mg/glove |
| Freedom of Holes | ASTM D5151-19 | Inspection level, G-I AQL 2.5 (In accordance with ASTM D6319-19) | Passed G-I, AQL 1.5 |
| Overall Length | ASTM D6319-19 | XS: 220mm min, S: 220mm min, M: 230mm min, L: 230mm min, XL: 230mm min | XS: 246–250mm, S: 248–252mm, M: 250–252mm, L: 248–251mm, XL: 245–248mm, XXL: 245–248mm |
| Width (Palm) | ASTM D6319-19 | XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm | XS: 77–78mm, S: 83–85mm, M: 94–96mm, L: 107–108mm, XL: 117–118mm, XXL: 124–125mm |
| Thickness (Palm) | ASTM D6319-19 | Measured in single wall at approximate center of palm area: 0.06mm min | XS: 0.06–0.07 mm, S: 0.06–0.07 mm, M: 0.06–0.07 mm, L: 0.06–0.07 mm, XL: 0.06–0.07 mm, XXL: 0.06–0.07 mm |
| Thickness (Finger) | ASTM D6319-19 | Measured in single wall at 13±3mm from the tip of middle finger region: 0.07mm min | XS: 0.08–0.09 mm, S: 0.08–0.09 mm, M: 0.08–0.10 mm, L: 0.08–0.10 mm, XL: 0.08–0.10 mm, XXL: 0.08–0.11 mm |
| Tensile Strength (Before Ageing) | ASTM D6319-19 | 14 MPa, for all sizes | XS: 21.67 MPa, S: 21.67 MPa, M: 22.14 MPa, L: 22.61 MPa, XL: 22.99 MPa, XXL: 22.35 MPa (average) |
| Tensile Strength (After Accelerated Ageing) | ASTM D6319-19 | 14 MPa, for all sizes | XS: 30.67 MPa, S: 27.80 MPa, M: 26.73 MPa, L: 22.44 MPa, XL: 23.15 MPa, XXL: 27.98 MPa (average) |
| Ultimate Elongation (Before Ageing) | ASTM D6319-19 | 500%, min for all sizes | XS: 547%, S: 529%, M: 533%, L: 523%, XL: 524%, XXL: 540% (average) |
| Ultimate Elongation (After Accelerated Ageing) | ASTM D6319-19 | 400%, min for all sizes | XS: 453%, S: 463%, M: 448%, L: 519%, XL: 516%, XXL: 458% (average) |
| Animal Irritation Test | ISO 10993-10 | Under the condition of study not an irritant. | Passed. No observable irreversible alteration on the skin; Primary Irritation Index (PII) was "0"; "negligible" irritation. |
| Dermal Sensitization Assay Test | ISO 10993-10 | Under the condition of the study not a sensitizer. | Passed. No sensitization induced. |
| Acute Systemic Toxicity | ISO 10993-11 | Not induce systemic toxicity. | Passed. No adverse toxic reaction demonstrated. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes used for each specific non-clinical test. However, it implicitly indicates that various sizes of gloves (XS, S, M, L, XL, XXL) were tested for several parameters (e.g., residual powder, length, width, thickness, tensile strength, ultimate elongation), meaning multiple samples were drawn for each size.
- Data Provenance: The tests were performed by Tec Gloves Industry (M) Sdn. Bhd. for their "Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile". This suggests the data provenance is from the manufacturer's internal testing. The country of origin of the manufacturer is Malaysia. The data is prospective as it was generated to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests performed are non-clinical, objective measurements based on specified ASTM and ISO standards, not subjective expert evaluation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. This is not a human-in-the-loop study requiring adjudication of expert opinions. The performance criteria are defined by established international standards (ASTM, ISO).
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 510(k) submission for patient examination gloves, which are physical medical devices, not an AI/software device that would involve human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on predefined acceptance criteria specified by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19, ISO 10993-10, ISO 10993-11). The results are quantitative measurements or qualitative observations (e.g., "not an irritant") against these established standard requirements. For example, for "Residual Powder Content," the ground truth is "Less than 2mg/glove."
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this 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.