(36 days)
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.
This 510(k) submission describes the Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., details on training set, experts, MRMC studies) are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4 standard. | Meets all requirements for physical and dimensions testing. (Inspection level S-2, AQL 4.0) |
| Pinhole / Water Leak Test: 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 Test: Based on ASTM D6124-06 for Starch. | Contains no more than 2 mg powder per glove, meeting "powder-free" claims. |
| Biocompatibility: | Meets biocompatibility requirements. (General statement, specific criteria not detailed) |
| Labeling Compliance: Does not claim hypoallergenic. | No special labeling claims; does not claim hypoallergenic. |
| Compliance with ASTM D-5250-00E4: | Conforms fully to ASTM D-5250-00E4 standard. |
| Compliance with 21 CFR references: | Conforms fully to applicable 21 CFR references. |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size for a given lot is not provided but would be determined by the AQL (Acceptable Quality Limit) and inspection level. This is a factory quality control measure, so the data provenance is from the manufacturer's internal testing in China (Shijiazhuang, Hebei, China). This is retrospective testing of manufactured products.
- Pinhole / Water Fill Test: Samplings of AQL 2.5, inspection level I. Similar to above, the specific sample size for a given lot is not provided. Data provenance is from the manufacturer's internal testing in China, retrospective.
- Primary Skin Irritation and Skin Sensitization: The document states that testing was conducted but does not specify the sample size or the data provenance beyond "with results showing." It is typically done on human subjects or animal models as per relevant ISO standards.
- Residual Powder Test: Not specified beyond "at finished inspection."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described is primarily for engineering performance and biocompatibility, not for diagnostic or therapeutic efficacy requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established standards (ASTM, FDA) for physical properties, chemical residue, and biological reactivity, not subjective interpretations 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 device is a physical barrier (glove), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
- Physical and Dimensions Testing: The ground truth is defined by the specifications in ASTM D-5250-00E4.
- Pinhole / Water Leak Test: The ground truth is defined by the FDA 1000 ml. Water Fill Test requirements.
- Primary Skin Irritation and Skin Sensitization: The ground truth is established by standard toxicological assessment protocols, typically involving expert interpretation of skin reactions.
- Residual Powder Test: The ground truth is defined by the maximum allowable powder content (2 mg/glove) as per ASTM D6124-06.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
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.