(59 days)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This looks like a 510(k) premarket notification for Nitrile Patient Examination Gloves, not an AI/ML medical device. Therefore, the questions about acceptance criteria, study design for AI, sample sizes, expert ground truth, MRMC studies, and standalone performance are not directly applicable.
Instead, the document details the device's adherence to established standards for medical gloves. Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document uses a comparison table against a predicate device and adherence to industry standards as its form of "acceptance criteria" and "reported device performance."
| Item | Acceptance Criteria (Predicate Device K171422 or Standard) | Reported Device Performance (Subject Device K211028) |
|---|---|---|
| General Characteristics | ||
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | Prevent contamination between patient and examiner | Prevent contamination between patient and examiner |
| Powdered/Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Labeling Information | Single-use, powder free, device color, device name, glove size and quantity | Single-use, powder free, device color, device name, glove size and quantity |
| Physical Dimensions | ||
| Length (XS, S, M, L, XL) | 230mm min | 220-230mm min (XS is 220, others 230) |
| Width (XS, S, M, L, XL) | 75-115mm (±5) | 70-120mm (XS-XL) (±10) |
| Thickness (Finger/Palm) | 0.05mm min | 0.05mm min |
| Overall Dimension Note | All meet ASTM D6319-19 requirements | All meet ASTM D6319-19 requirements |
| Performance (ASTM D6319) | ||
| Tensile Strength (Before Aging) | 14MPa, min | 14MPa, min |
| Ultimate Elongation (Before Aging) | 500% min | 500% min |
| Tensile Strength (After Aging) | 14MPa, min | 14MPa, min |
| Ultimate Elongation (After Aging) | 400% min | 400% min |
| Freedom from Holes (ASTMD5151) | AQL=2.5 | AQL=2.5 |
| Powder Content (ASTM D6124) | Meet requirements of ASTM D6124 | 0.07 mg per glove. Meet requirements of ASTM D6124 |
| Safety/Biocompatibility | ||
| Material | Nitrile | Nitrile |
| Irritation (ISO 10993-10) | Not an irritant | Not an irritant |
| Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Cytotoxicity (ISO 10993-5) | Not cytotoxic | Not cytotoxic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for performance and safety): The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for holes, tensile strength, or biocompatibility). However, it references conformity to international standards (ASTM and ISO). These standards typically define sampling plans for lot release and quality control.
- Data Provenance: The tests were conducted by the manufacturer, Huayuan Medical Technology (Shangqiu) Co., Ltd. located in China. The data's origin would therefore be from their internal testing processes. The study is prospective in the sense that the tests were performed on the manufactured 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 is not applicable for this type of device. "Ground truth" in the context of medical gloves is established by objective measurements against established physical, chemical, and biological standards (ASTM, ISO). There are no human expert interpretations involved in determining if a glove has a hole or its tensile strength.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the evaluation relies on objective measurement against defined specifications, not 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 is 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 not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the pass/fail criteria) is based on established international and national consensus standards for medical gloves:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
These standards define the acceptable physical properties, barrier integrity, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.
9. How the ground truth for the training set was established
Not applicable.
§ 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.