(186 days)
Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves Powder Free-Black 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 black in color and are powder free and non-sterile.
The provided text describes the regulatory clearance for "JR MEDIC Nitrile Examination Gloves Powder Free- Black" and includes performance data compared to a predicate device. However, it does not describe an AI/ML powered device or a study that evaluates its performance for diagnostic or predictive purposes. This information pertains to medical gloves, which are physical products with established performance standards.
Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.
I will provide the available information from the text regarding the acceptance criteria and performance of the medical glove.
Acceptance Criteria and Device Performance for JR MEDIC Nitrile Examination Gloves Powder Free-Black
The device is a medical glove, and its performance is evaluated against established ASTM standards for physical properties and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance (JR MEDIC Nitrile Examination Gloves Powder Free-Black) |
|---|---|---|---|
| Dimensions | ASTM D6319-2019 | Length: Min 230 mm (all sizes) | X-Small: 483 mm, Small: 484 mm, Medium: 485 mm, Large: 486 mm, X-Large: 486 mm (All meet criteria) |
| Width: 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 (All meet criteria) | ||
| Physical Properties (Before Aging) | ASTM D6319-2019 | Tensile Strength: Min 14 Mpa (all sizes) | X-Small: 18.44Mpa, Small: 18.49Mpa, Medium: 18.56Mpa, Large: 18.62Mpa, X-Large: 18.64Mpa (All meet criteria) |
| Ultimate Elongation: Min 500% (all sizes) | X-Small: 683%, Small: 687%, Medium: 692%, Large: 695%, X-Large: 698% (All meet criteria) | ||
| Physical Properties (After Aging) | ASTM D6319-2019 | Tensile Strength: Min 14 Mpa (all sizes) | X-Small: 17.49Mpa, Small: 17.53Mpa, Medium: 17.65Mpa, Large: 17.71Mpa, X-Large: 17.76Mpa (All meet criteria) |
| Ultimate Elongation: Min 400% (all sizes) | X-Small: 656%, Small: 660%, Medium: 663%, Large: 666%, X-Large: 669% (All meet criteria) | ||
| Thickness | ASTM D6319-2019 | Palm: 0.05 mm min (all sizes), Finger: 0.05 mm min (all sizes) | Palm: 0.19mm (all sizes), Finger: 0.21mm (all sizes) (All meet criteria) |
| Powder Residue | ASTM D6124-06 (Reapproved 2017) | ≤2 mg/glove | 0.16 mg/glove (for all sizes X-Small, Small, Medium, Large, X-Large) (Meets criteria) |
| Water Tight | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL 1.5 (Meets criteria) |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Under the condition of study not an irritant | Under the condition of study not an irritant (Meets criteria) |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer (Meets criteria) |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic (Note: This is a discrepancy. The acceptance criteria states "non cytotoxic," but the result is "cytotoxic." Further investigation would be needed on why this was deemed acceptable for clearance.) |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017(E) | 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 (Meets criteria) |
| Biocompatibility - Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41 | Under the conditions of the study non pyrogenic | No data available in the table, but the predicate device met this criteria. In the summary table on page 4, it states "No data available" for the subject device but lists "Same" in remarks implying it aligns with the predicate which was "non pyrogenic". |
2. Sample size 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 for each test. However, tests like ASTM D6319-2019 and D5151-2019 involve specific sampling plans (e.g., AQL for water tightness) where a number of gloves are sampled from a lot.
- The data provenance is from Malyasia, as the applicant (JR Engineering & Medical Technologies (M) Sdn. Bhd.) is located there. The studies are non-clinical tests, likely conducted in a laboratory setting to evaluate the product's physical and biological properties.
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)
- Not applicable. This is for a medical glove, not an AI/ML diagnostic device. Ground truth is established by objective measurements against industry standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for a medical glove, not an AI/ML diagnostic device requiring expert review and 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 is for a medical glove, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a medical glove, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance evaluation of the medical glove is based on established international and national standards (such as ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ISO 10993 series). These standards define objective pass/fail criteria for physical properties and biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device requiring a training set.
§ 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.