(84 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes the 510(k) summary for the Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.
This document is a premarket notification for a Class I medical device (patient examination gloves). The performance criteria and testing mentioned relate to the physical properties, biocompatibility, and acceptable quality levels (AQL) of the gloves, not to a digital algorithm or AI.
Therefore, many of the requested fields are Not Applicable in this context, as they pertain to the evaluation of AI/algorithm performance.
Here's a breakdown based on the provided information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00E4) | All testing meets requirements. Inspection level S-2, AQL 4.0. |
| Pinhole Requirements (FDA 1000 ml. Water Fill Test) | Meets requirements. Samplings of AQL 2.5, inspection level I. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder (ASTM D6124-06 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Requirements met (implied by meeting skin irritation and sensitization tests, which are a part of biocompatibility assessment for surface-contacting devices). |
| Labeling (No special claims, not hypoallergenic) | Labeling claims met. |
| Conformance to ASTM D-5250-00E4 standard | Conforms fully. |
| Conformance to applicable 21 CFR references | Conforms fully. |
2. Sample size 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:
- For physical and dimensions testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but determined by an AQL table based on lot size and inspection level).
- For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size 'n' is not explicitly stated).
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., which is located in Shijiazhuang, Hebei, China. The testing would have been prospective 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)
- Not Applicable. This device is a physical product (gloves), not an AI/algorithm. Ground truth is established through standardized physical, chemical, and biological tests, not expert consensus in the diagnostic sense. The "experts" would be laboratory personnel skilled in performing these specific ASTM and FDA test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Testing involves objective measurements against established standards, not interpretation or adjudication of diagnostic findings.
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 physical product, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product, not an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established industry standards and regulatory requirements:
- ASTM D-5250-00E4 standard specifications for vinyl patient examination gloves.
- FDA 1000 ml Water Fill Test for pinhole detection.
- ASTM D6124-06 for residual powder.
- Biocompatibility testing guidelines (e.g., ISO 10993 series, though not explicitly cited, these tests adhere to such principles).
8. The sample size for the training set
- Not Applicable. This is a physical product. There is no concept of a "training set" in the context of device testing for physical properties. Production processes are monitored using statistical process control, which might involve continuous sampling, but not in the "training set" sense of an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See 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.