(268 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.
Powder Free Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
This document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided pertains to the substantial equivalence of the subject device to a predicate device, focusing on non-clinical performance characteristics to demonstrate safety and effectiveness.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by the ASTM D 5250-06 (Reapproved 2015) Standard Specification for Poly(Vinyl Chloride) Gloves For Medical Application. The predicate device and the subject device both aim to meet these requirements.
| Characteristics | Acceptance Criteria (ASTM D 5250-06 (2015) requirements) | Reported Device Performance (Subject Device K180381) | Result of Comparison (Predicate vs Subject) | Conclusion (Subject Device performance) |
|---|---|---|---|---|
| Physical Properties: | ||||
| Tensile Strength (Before aging) | 11 Mpa minimum | 14.4-17.1 Mpa | Same (Met/Exceeded) | Pass (Meets/Exceeds criteria) |
| Tensile Strength (After aging) | 11 Mpa minimum | 14.1-16.9 Mpa | Same (Met/Exceeded) | Pass (Meets/Exceeds criteria) |
| Elongation (Before aging) | 300% minimum | 390-480% | Same (Met/Exceeded) | Pass (Meets/Exceeds criteria) |
| Elongation (After aging) | 300% minimum | 380-470% | Same (Met/Exceeded) | Pass (Meets/Exceeds criteria) |
| Freedom from Pinhole | G-I, AQL 2.5 (Meets ASTM D 5250-06 (2015) requirements) | Meets AQL 2.5 requirements | Same | Pass (Meets criteria) |
| Dimensions: | Meets ASTM D 5250-06 (2015) requirements | Same | Pass (Meets criteria) | |
| - Overall Length (mm) | 230 for all sizes minimum | S: 233-241mm, M:231-242mm, L:230-244mm, XL: 234-245mm | N/A (Directly compared to standard) | Pass (Meets/Exceeds criteria) |
| - Width (mm) | S: 85 ± 5, M: 95 ± 5, L: 105±5, XL: 115±5 | S: 87-88 mm, M: 97-98 mm, L: 107-108 mm, XL: 118-119 mm | N/A (Directly compared to standard) | Pass (Meets criteria) |
| - Palm Thickness (mm) | 0.08mm minimum | 0.08mm | N/A (Directly compared to standard) | Pass (Meets criteria) |
| - Finger Thickness (mm) | 0.05mm minimum | 0.09-0.11mm | N/A (Directly compared to standard) | Pass (Meets/Exceeds criteria) |
| Residual Powder | Not more than 2 mg per glove (Meets Applicable Definition for Powder Free) | 0.20 mg/glove | Same (Met/Exceeded) | Pass (Meets/Exceeds criteria) |
| Biocompatibility: | ||||
| - Primary Skin Irritation | Under conditions of the study, not an irritant | Under conditions of the study, not an irritant | Same | Pass (Not an irritant) |
| - Dermal Sensitization | Under conditions of the study, not an irritant | Under conditions of the study, not an irritant | Same | Pass (Not an irritant) |
| - Cytotoxicity Test | N/A (Predicate had no data) | Under the conditions of this study, not a cytotoxic potential | Different (Subject had data) | Pass (Not a cytotoxic potential) |
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 specific numerical sample sizes for each test. Instead, it refers to "Inspection Level and AQL" (Acceptable Quality Level) from the ASTM standards for some tests (e.g., S-2, AQL 4.0 for dimensions and tensile strength; G-I, AQL 2.5 for pinhole). These AQLs imply a sampling plan rather than a fixed sample size.
- Pinhole: Inspection Level G-I, AQL 2.5.
- Dimensions, Tensile Strength, Ultimate Elongation: Inspection Level S-2, AQL 4.0.
- Residual Powder: N=5 (5 gloves were tested).
- Biocompatibility Tests (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity Test): No sample sizes are specified for these in the table; the results are qualitative ("not an irritant," "not a cytotoxic potential").
The data provenance is from Shanxi Hongjin Plastic Technology Co., Ltd in China, as indicated by their address on the document. The studies are non-clinical lab tests conducted to support the 510(k) submission, implying a prospective data generation process for the purpose of regulatory approval.
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 section is not applicable as the device is a medical glove, and the "ground truth" is based on objective physical, chemical, and biological performance characteristics measured by laboratory tests and adherence to industry standards (ASTM D5250-06), not expert medical interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiologists reading medical images) to establish consensus ground truth. The tests for these gloves are objective measurements.
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
This is not applicable. This type of study relates to AI-assisted diagnostic devices and human reader performance, not physical medical devices like examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This concept applies to AI/software as a medical device, where the algorithm performs a task independently. The tests performed here are direct measurements of a physical product's attributes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements against pre-defined specifications and compliance with recognized industry standards, specifically ASTM D 5250-06 (Reapproved 2015). For biocompatibility, it's based on standard biological evaluation tests determining if the material is an irritant or cytotoxic.
8. The sample size for the training set
This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing and performance of a physical product according to established standards, not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.