(190 days)
Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.
The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, Powder Free. It demonstrates the substantial equivalence of the proposed device to a legally marketed predicate device (Primus Nitrile Examination Gloves, K143477).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Nitrile Patient Examination Gloves, Powder Free (Lalan Rubbers (Pvt) Ltd)
| Characteristic | Acceptance Criteria (Predicate Device / ASTM D6319) | Reported Device Performance (Nitrile Patient Examination Gloves, Powder Free) |
|---|---|---|
| Physical Characteristics: | ASTM D6319 requirements | Meets ASTM D6319 requirements |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (XS) | $70 \pm 10$ | $\leq 80$ |
| Palm width (S) | $80 \pm 10$ | $85 \pm 5$ |
| Palm width (M) | $95 \pm 10$ | $95 \pm 5$ |
| Palm width (L) | $110 \pm 10$ | $105 \pm 5$ |
| Palm width (XL) | $120 \pm 10$ | $\geq 110$ |
| Thickness (Finger) | Minimum 0.05mm | $0.09 \pm 0.01$mm |
| Thickness (Palm) | Minimum 0.05mm | $0.07 \pm 0.01$mm |
| Thickness (Cuff) | Not explicitly defined (implied by ASTM) | $0.05 \pm 0.01$mm |
| Physical Properties: | ASTM D6319 requirements for tensile strength and ultimate elongation | Meets ASTM D6319 requirements |
| Tensile Strength (Before Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Tensile Strength (After Aging) | Minimum 14 MPa | Minimum 14 MPa |
| Ultimate Elongation (Before Aging) | Minimum 500% | Minimum 500% |
| Ultimate Elongation (After Aging) | Minimum 400% | Minimum 400% |
| Freedom from holes: | ASTM D6319 requirements of GI, AQL 2.5 | Meets ASTM D6319 and ASTM D5151 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319 requirements; Not more than 2.0mg/glove | Meets applicable requirement for powder free; $\leq$ 2 mg per glove |
| Biocompatibility: | ASTM and ISO standards | - |
| Skin Irritation Test | Not an irritant (Under predicate study conditions) | Under the conditions of the study, not an irritant (ISO10993-23:2021) |
| Skin Sensitization Test | Not a sensitizer (Under predicate study conditions) | Under the conditions of the study, not a sensitizer (ISO 10993-10:2010) |
| In Vitro Cytotoxicity | Not explicitly stated for predicate | Diluted concentrations 12.5% and 6.25% are not cytotoxic. Undiluted extract (100%), diluted concentrations 50% & 25% are cytotoxic. (ISO 10993-5:2009) |
| Acute Systemic Toxicity | Not explicitly stated for predicate | Under the conditions of the study, no evidence of systemic toxicity (ISO 10993-11: 2017) |
| Shelf Life | 3 years | 3 years (EN, 455-4:2009) |
2. Sample size used for the test set and the data provenance
The document specifies that non-clinical tests were conducted to verify that the proposed subject device met all design specifications. The sample sizes for each specific test (e.g., number of gloves for physical testing, number of samples for biocompatibility) are not explicitly provided in this summary document. However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes and methodologies.
The "data provenance" (country of origin, retrospective/prospective) is not detailed for the test samples, but the tests were performed by Lalan Rubbers (Pvt) Ltd in Sri Lanka, which is the manufacturer. The tests are prospective in nature, as they involve testing newly manufactured devices against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device (Nitrile Patient Examination Gloves) does not involve expert interpretation or clinical diagnosis that would require human "ground truth" establishment in the typical sense of AI/clinical decision support systems. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM D6319, ISO 10993 series). Therefore, there were no "experts" establishing a subjective ground truth for a test set in this context. The acceptance criteria are quantitative and based on published standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is objective measurement against established physical and chemical standards. There is no subjective interpretation requiring adjudication.
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 device is a medical glove, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.
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 device. The tests performed are for the physical, chemical, and biological properties of the glove itself.
7. The type of ground truth used
The ground truth used for this device's performance evaluation against acceptance criteria is objective measurement against recognized international standards and specifications. Specifically:
- Physical and Dimensional Properties: ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- Freedom from holes: ASTM D6319 and ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Powder Residual: ASTM D6319 and ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Biocompatibility: ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 10993-5 (Biological evaluation of medical devices for irritation, sensitization, systemic toxicity, and cytotoxicity)
- Shelf Life: EN 455-4:2009 (Medical gloves for single use Part 4: Requirements and testing for shelf life determination)
8. The sample size for the training set
Not applicable. This product is not an AI/machine learning model, so there is no concept of a "training set" in this context. The design and manufacturing process for the gloves are developed based on general engineering and material science principles, and then verified through the non-clinical tests mentioned.
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.