(45 days)
A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.
The Powder-free vinyl exam glove is a disposable Class 1 medical device made from PVC material and is intended to be worn on the hands of health care personnel for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
The provided documentation pertains to a 510(k) premarket notification for "Powder-Free Vinyl Exam Gloves" by SHANGHAI LANFAN CO., LTD. This document does not describe a study involving a device that analyzes data or provides diagnostic information. Instead, it concerns a Class I medical device (gloves) and demonstrates its substantial equivalence to predicate devices based on physical properties and biocompatibility. Therefore, most of the requested information regarding acceptance criteria and studies for device performance (especially for AI/software devices) is not applicable.
However, I can extract the relevant information regarding the glove's "acceptance criteria" through performance attributes and the testing conducted to meet those criteria.
1. A table of acceptance criteria and the reported device performance
For medical gloves, acceptance criteria typically relate to physical properties and barrier integrity. The document states that the device meets the "current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves." While the specific values from ASTM D5250-06 are not detailed in this summary, the general categories of assessment are inferred.
| Acceptance Criteria (Inferred from ASTM D5250-06 and biocompatibility) | Reported Device Performance |
|---|---|
| Barrier Integrity (e.g., freedom from holes) | Meets ASTM D5250-06 Standard Specification. |
| Physical Dimensions (e.g., length, palm width, thickness) | Meets ASTM D5250-06 Standard Specification. |
| Physical Properties (e.g., tensile strength, elongation) | Meets ASTM D5250-06 Standard Specification. |
| Freedom from powder (for powder-free claims) | Confirmed as "Powder-free Vinyl Exam Gloves" and coated with PU for donning. |
| Biocompatibility (Primary Skin Irritation) | Indicates no irritation. |
| Biocompatibility (Delayed Contact Sensitization) | Indicates no sensitization. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for testing according to ASTM D5250-06. Such standards typically define sampling plans. The data provenance is China, as the submitter, SHANGHAI LANFAN CO., LTD, is located in Shanghai, China. The testing appears to be "retrospective" in the sense that it's standard quality control and product validation testing rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. This device is a glove, and its performance is assessed via objective physical and chemical tests, not by expert interpretation of data.
4. Adjudication method for the test set
This question is not applicable as the performance is evaluated through objective measurements against established standards, not via expert 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
This question is not applicable as the device is a medical glove, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical glove.
7. The type of ground truth used
For physical and chemical properties:
- Standard Specifications: ASTM D5250-06 "Standard Specification for Polyvinyl Examination Gloves for Medical Application" serves as the ground truth for acceptable performance limits and test methods for physical characteristics.
- Biocompatibility Testing Standards: Standards for Primary Skin Irritation (rabbit) and Delayed Contact Sensitization (guinea pig) serve as the ground truth for biocompatibility.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a medical glove. The product is manufactured and tested according to specified standards.
9. How the ground truth for the training set was established
This question is 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.