(79 days)
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.
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) 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 available in Orange & Purple color and are powder free and are provided non-sterile. These gloves have a shelf life for 3 years.
This document describes the premarket notification (510k) for JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against established standards and a predicate device, rather than a clinical study with human subjects, AI algorithms, or ground truth established by experts.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables detailing the acceptance criteria (standards) and the device's performance for both the orange and purple gloves. Below is a consolidated table with key physical, chemical, and biological performance characteristics.
| Characteristics | Standards / Purpose | Acceptance Criteria | Reported Device Performance (Orange Gloves) | Reported Device Performance (Purple Gloves) |
|---|---|---|---|---|
| Physical Dimensions | ||||
| Length | ASTM D6319-2019 (To determine length) | Min 220mm (XS, S), Min 230mm (M, L, XL) | XS: 236mm, S: 236mm, M: 238mm, L: 238mm, XL: 240mm | XS: 245mm, S: 245mm, M: 246mm, L: 248mm, XL: 248mm |
| Width | ASTM D6319-2019 (To determine width) | XS: 70+/-10mm, S: 80+/-10mm, M: 95+/-10mm, L: 110+/-10mm, XL: 120+/-10mm | XS: 74mm, S: 84mm, M: 94mm, L: 104mm, XL: 114mm | XS: 76mm, S: 85mm, M: 95mm, L: 104mm, XL: 115mm |
| Thickness (Palm) | ASTM D6319-2019 (To determine thickness) | Palm 0.05 mm min for all sizes | XS, S, M, L, XL: 0.18mm | XS, S, M, L, XL: 0.18mm |
| Thickness (Finger) | ASTM D6319-2019 (To determine thickness) | Finger 0.05 mm min for all sizes | XS, S, M, L, XL: 0.20mm | XS, S, M, L, XL: 0.21mm |
| Physical Properties | ||||
| Tensile Strength (Before Aging) | ASTM D6319-2019 (To determine tensile strength) | 14 Mpa Min for all sizes | XS: 22.77 Mpa, S: 22.80 Mpa, M: 24.46 Mpa, L: 24.51 Mpa, XL: 24.59 Mpa | XS: 22.78 Mpa, S: 22.82 Mpa, M: 24.47 Mpa, L: 24.52 Mpa, XL: 24.58 Mpa |
| Tensile Strength (After Aging) | ASTM D6319-2019 (To determine tensile strength) | 14 Mpa Min for all sizes | XS: 20.50 Mpa, S: 20.69 Mpa, M: 21.28 Mpa, L: 21.34 Mpa, XL: 21.36 Mpa | XS: 20.48 Mpa, S: 20.67 Mpa, M: 21.30 Mpa, L: 21.35 Mpa, XL: 21.36 Mpa |
| Ultimate Elongation (Before Aging) | ASTM D6319-2019 (To determine ultimate elongation) | 500% Min for all sizes | XS: 885%, S: 886%, M: 888%, L: 891%, XL: 892% | XS: 884%, S: 885%, M: 887%, L: 892%, XL: 893% |
| Ultimate Elongation (After Aging) | ASTM D6319-2019 (To determine ultimate elongation) | 400% Min for all sizes | XS: 760%, S: 764%, M: 767%, L: 769%, XL: 772% | XS: 759%, S: 763%, M: 766%, L: 768%, XL: 772% |
| Watertight (Holes) | ASTM D5151-2019 (To determine holes) | AQL 2.5 (for subject device K222349), AQL 1.5 (for predicate K192333) Note: AQL 2.5 is a less stringent acceptance criteria than AQL 1.5, which is noted as "Similar" in comparison analysis | Passes AQL 2.5 | Passes AQL 2.5 |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) (To determine residual powder) | ≤2 mg/glove Max | XS, S, M, L, XL: 0.16 mg/glove | XS, S, M, L, XL: 0.16 mg/glove |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10 (To determine dermal irritation in Rabbits) | Under the condition of study not an irritant | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Dermal Sensitization | ISO 10993-10 (To determine skin sensitization potential in Guinea Pig) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| In vitro Cytotoxicity | ISO 10993-5:2009 (To evaluate cytotoxic potential) | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. |
| Acute Systemic Toxicity | ISO 10993-11:2017 (To determine acute systemic toxicity potential) | 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 | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test. However, the tests are adherence to ASTM and ISO standards, which define the sample sizes and methodology for such testing. For example, ASTM D5151-2019 (Watertightness) involves sampling a number of gloves from a lot to determine AQL (Acceptance Quality Limit). The testing presumably took place in Malaysia, where the manufacturer is located. The nature of these tests (e.g., physical property measurements, biocompatibility) suggests they are prospective, as new gloves are being manufactured and tested to ensure they meet specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical glove, not a diagnostic AI device requiring expert interpretation of medical images or data. The "ground truth" for the test set is established by the specifications defined in the relevant ASTM and ISO standards for physical, chemical, and biological properties of examination gloves. Therefore, there are no "experts" in the sense of radiologists or clinicians establishing ground truth for the test set. The validation relies on standard laboratory testing procedures performed by qualified technicians/laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation of complex data where adjudication would be necessary. The testing involves objective measurements against predefined criteria.
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 not an AI/software device or a diagnostic tool that involves human readers. It is a physical medical device (examination gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on standardized test methods and specifications (ASTM and ISO standards). For example:
- Physical Property Ground Truth: Defined by acceptable ranges for length, width, thickness, tensile strength, and elongation as per ASTM D6319-2019.
- Watertightness Ground Truth: Defined by an Acceptance Quality Limit (AQL) as per ASTM D5151-2019.
- Chemical Property Ground Truth: Defined by maximum allowable powder residue as per ASTM D6124-06.
- Biocompatibility Ground Truth: Defined by the absence of irritation, sensitization, or systemic toxicity as per ISO 10993 series, and a determination regarding cytotoxicity.
8. The sample size for the training set
Not applicable. As this is a traditional medical device (gloves) and not an AI/machine learning model, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.