(16 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.
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 requirements of ASTM Standard D5250-00.
The provided text describes the 510(k) summary for Shijiazhuang Eversharp Plastics Products Co., Ltd.'s Synthetic (White) Vinyl Patient Examination Gloves-Powder Free.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device and adherence to established industry standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Standard: Conformity to ASTM Standard D5250-00 for Synthetic Vinyl Patient Examination Gloves. | * Physical and Dimensions Testing: Meets all requirements of ASTM Standard D5250-00. (Inspection Level S-2, AQL 4.0) |
| Pinhole/Barrier Integrity: Meets FDA requirements for barrier integrity (e.g., Water Fill Test). | * FDA 1000 ml. Water Fill Test: Sampled at AQL 2.5, Inspection Level I, meeting all requirements. |
| Biocompatibility - Primary Skin Irritation: No primary skin irritation reactions. | * Primary Skin Irritation Testing: Results showed no primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization: No skin sensitization reactions (allergic contact dermatitis). | * Skin Sensitization Testing: Results showed no sensitization reactions. |
| Powder-Free Claim: Contains no more than 2 mg powder per glove. | * Residual Powder Test (ASTM D6124-01 for Starch): Confirms gloves meet "powder-free" claims. |
| Substantial Equivalence: Demonstrated equivalence to the predicate device. | * Device is deemed substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves for physical testing, number of subjects for biocompatibility). However, it mentions:
- Physical and Dimensions Testing: The inspection level and AQL (Acceptable Quality Level) values are provided: "Inspection Level S-2, AQL 4.0." These are statistical sampling plans where a certain number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. While not an explicit sample size, they define the statistical rigor of the sampling.
- FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I." Similar to the above, this indicates a statistical sampling plan.
- Biocompatibility Testing (Primary Skin Irritation and Skin Sensitization): The specific number of subjects or samples is not provided, but the tests were "conducted with results showing no primary skin irritant or sensitization reactions."
Data Provenance: The document implies the data was generated internally by Shijiazhuang Eversharp Plastics Products Co., Ltd. for their product. There is no mention of country of origin of the data beyond the manufacturer's location (China). The studies are inherently prospective as they are tests performed on the device to prove its compliance with standards and claims for premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number or qualifications of experts used to establish the ground truth for the test set. The tests performed (physical, water fill, biocompatibility, residual powder) are typically standardized laboratory tests, where "ground truth" is established by adherence to the specified test methodology and objective measurements, rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective laboratory measurements (e.g., physical dimensions, water leakage, chemical residues, biological responses in animal models or in-vitro tests for irritation/sensitization). There is no "adjudication" in the sense of multiple human readers or experts reviewing the same data and reaching a consensus. The results are quantitative or qualitative assessments based on predefined criteria in the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device for patient examination gloves. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images or data, and the study assesses the impact of AI assistance on their diagnostic performance. This device is not an imaging or diagnostic AI product, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The performance metrics are related to the physical and chemical properties of the gloves themselves.
7. Type of Ground Truth Used
The "ground truth" used for these tests is based on:
- Industry Standards: Specifically ASTM Standard D5250-00, which defines the expected physical properties and performance characteristics of synthetic vinyl patient examination gloves.
- Regulatory Requirements: FDA requirements for pinhole/barrier integrity (Water Fill Test) and biocompatibility.
- Manufacturer's Claims: The claim of "powder-free" is verified against a specific standard (ASTM D6124-01).
These are objective, quantitative, or qualitatively verifiable standards and protocols.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm. There is no "training set" in the context of machine learning. The manufacturing process is controlled to produce gloves that consistently meet the required specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reasons as #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.