(100 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
The provided document describes the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K142409) and seeks to prove its substantial equivalence to a predicate device (K061562). The study conducted is a non-clinical performance study comparing the subject device against the predicate device based on established standards and FDA requirements.
Here's the breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Stated Standard ASTM D5250-06(2011) or other) | Reported Device Performance (Subject Device K142409) | Result of Comparison to Predicate & Acceptance |
|---|---|---|---|
| Material | Vinyl and oil-based liquid Nitrile compound (plasticizer type different) | Vinyl and oil-based liquid Nitrile compound (plasticizer type different) | Similar |
| Color | Blue | Blue | Similar |
| Tensile Strength (Mpa) | |||
| - Before aging | 11 Mpa min | 15.2 Mpa min | Pass (Exceeds standard and similar to predicate) |
| - After aging | 11 Mpa min | 14.6 Mpa min | Pass (Exceeds standard and similar to predicate) |
| Ultimate Elongation (%) | |||
| - Before aging | 300% min | 390% min | Pass (Exceeds standard and similar to predicate) |
| - After aging | 300% min | 360% min | Pass (Exceeds standard and similar to predicate) |
| Freedom from Pinholes | AQL 2.5 (G-I) | AQL 1.5 (G-I) | Pass (Exceeds standard and similar to predicate, lower AQL is better) |
| Overall Length (mm) | 230 for all sizes min (S-2, AQL4.0) | 239 mm (for all sizes) | Pass (Exceeds standard and similar to predicate) |
| Width (mm) | S: 85±5, M: 95±5, L: 105±5, XL: 115±5 (S-2, AQL4.0) | S: 87, M: 97, L: 107, XL: 118 | Pass (Within range and similar to predicate) |
| Palm Thickness (mm) | 0.08 mm min (S-2, AQL4.0) | 0.08 mm | Pass (Meets standard and similar to predicate) |
| Finger Thickness (mm) | 0.05 mm min (S-2, AQL4.0) | 0.10 mm | Pass (Exceeds standard and similar to predicate) |
| Residual Powder | Not more than 2mg per glove (N=5) | Not more than 2mg per glove | Pass (Meets standard and similar to predicate) |
| Primary Skin Irritation Test | Under conditions of the study, not an irritant (ISO 10993-10) | Under conditions of the study, not an irritant | Similar (Pass) |
| Dermal Sensitization Assay | Under conditions of the study, not an irritant (ISO 10993-10) | Under conditions of the study, not an irritant | Similar (Pass) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The sample sizes for each test are indicated by the "Inspection Level and AQL" or "N" values.
- For physical dimensions (Overall Length, Width, Palm Thickness, Finger Thickness), Tensile Strength, and Ultimate Elongation: S-2, AQL4.0.
- For Pinhole: G-I, AQL1.5.
- For Residual Powder: N=5 (5 gloves tested).
- For Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The specific number of samples (e.g., animals, human subjects, in-vitro replicates) is not explicitly stated, but the tests were performed "Under conditions of the study".
- Data Provenance: The study was conducted by Grand Work Plastic Products Co., Ltd., which is located in Zanhuang, Hebei, China. The data originates from this manufacturer. It is a prospective study as the tests were performed on the subject device to demonstrate compliance.
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 study is a physical and chemical performance test of a medical device (examination gloves), not an AI/clinical diagnostic device. Therefore, it does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists, pathologists). The "ground truth" is established by the pre-defined technical standards (e.g., ASTM D5250-06(2011), ISO 10993-10) and FDA requirements. The tests are performed by technicians in a laboratory setting according to specified protocols.
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 clinical adjudication. The results are quantitative measurements or qualitative observations against a set standard.
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 performance study for a physical device (examination gloves), not a comparative effectiveness study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a performance study for a physical device (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this study is based on established industry standards and regulatory requirements. Specifically:
- ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
- ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
- FDA requirements (e.g., for pinhole AQL).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI study; there is no training set involved.
9. How the ground truth for the training set was established:
Not applicable. There is no 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.