(109 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 a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided document describes the acceptance criteria and the study conducted for Shandong Zhanpeng Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free, Yellow Color.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical and Dimensions | ASTM-D-5250-06 | Meets all requirements (Specifics not detailed) | Meets all requirements for Physical and Dimensions Testing |
| Pinhole/Water Leak | FDA 1000 ml. Water Fill Test | AOL 2.5, Inspection Level I | Meets these requirements |
| Biocompatibility | Primary Skin Irritation Test | No primary skin irritant reactions | Results showed no primary skin irritant reactions |
| Biocompatibility | Skin Sensitization (allergic contact dermatitis) Test | No sensitization reactions | Results showed no sensitization reactions |
| Powder Content | Powder-Free Claim | No more than 2 mg powder per glove | Conducted to insure gloves meet "powder-free" claims |
2. Sample size used for the test set and the data provenance:
- Physical and Dimensions Testing: Inspection Level S-2, AOL 2.5 (Specific sample size not provided, but these are statistical sampling plans). Data provenance is from testing conducted by the manufacturer, presumably in China.
- FDA 1000 ml. Water Fill Test: Samplings of AOL 2.5, Inspection Level I (Specific sample size not provided, but these are statistical sampling plans). Data provenance is from testing conducted by the manufacturer, presumably in China.
- Primary Skin Irritation and Skin Sensitization Testing: Sample size is not specified. Data provenance is from testing conducted by the manufacturer.
The data is retrospective as it was collected as part of the 510(k) submission process to demonstrate substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a medical glove, and the "ground truth" is established through standardized laboratory tests (e.g., ASTM standards, FDA water fill test, biocompatibility tests) rather than expert interpretation of images or clinical data.
4. Adjudication method for the test set:
Not applicable for this type of device and testing. The evaluation of test results is based on meeting predefined specifications of the ASTM standard and FDA requirements.
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 device is a medical glove; it does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical glove; it does not involve an algorithm.
7. The type of ground truth used:
The ground truth is based on the results of standardized laboratory testing as per ASTM-D-5250-06 and the FDA 1000 ml Water Fill Test, as well as biocompatibility testing. This is objective data derived from physical and chemical properties and biological responses, not expert consensus or pathology in the context of diagnostic imaging.
8. The sample size for the training set:
Not applicable. This device is a medical glove, and its performance is established through direct physical, dimensional, and biocompatibility testing, not through machine learning models requiring training data.
9. How the ground truth for the training set was established:
Not applicable for the reasons stated above.
§ 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.