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510(k) Data Aggregation
(251 days)
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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-06 and FDA requirements) | Reported Device Performance (Zibo Intco Medical Products) |
|---|---|
| Physical and Dimensions Testing: | Inspection Level S-2, AQL 2.5 was met. |
| - Tensile Strength (Mpa) - Before Aging | Average 19.2 Mpa |
| - Ultimate Elongations (%) - Before Aging | Average 501% |
| - Tensile Strength (Mpa) - After Aging | Average 16.8 Mpa |
| - Ultimate Elongations (%) - After Aging | Average 472% |
| - Overall Length (Medium Size) | Average over 249mm (Meets predicate's "Substantially equivalent") |
| - Width of Palm (Medium Size) | Average 95mm (Meets predicate's "Substantially equivalent") |
| - Palm Thickness | Average 0.085 mm (Meets predicate's "Substantially equivalent") |
| - Figure Thickness | Average 0.088 mm (Meets predicate's "Substantially equivalent") |
| Key Performance Attributes: | |
| - Residual Powder (per glove) | < 2 mg (according to ASTM D6124-06) |
| - Pinhole Results (AQL) | Less than 2 defective gloves out of 125, AQL 2.5 met (according to ASTM D5151-06) |
| Biocompatibility Testing: | |
| - Primary Skin Irritation | Not an irritant |
| - Dermal Sensitization (Allergic Contact Dermatitis) | Not a sensitizer |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing, Pinhole Results: Inspection Level S-2, AQL 2.5 for physical/dimensions and Inspection Level I, AQL 2.5 for the FDA 1000 ml. Water Fill Test (pinhole). The specific number of gloves tested is implicitly defined by these AQL (Acceptable Quality Limit) levels and inspection levels, but the exact sample number isn't stated directly. For pinhole, it specifies "125 pieces gloves" were tested.
- Residual Powder: Not explicitly stated, but performed according to ASTM D6124-06.
- Biocompatibility (Primary Skin Irritation, Skin Sensitization): Not explicitly stated, but testing was conducted.
- Data Provenance: The testing was performed by Zibo Intco Medical Products, Co. Ltd. in China, as per the submitter's identification. The data is retrospective, as it's part of a 510(k) submission showing pre-market testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The "ground truth" for glove performance characteristics like tensile strength, pinholes, or powder content is established by standardized testing methods (e.g., ASTM standards) and objective measurements, not by expert consensus or clinical interpretation. Biocompatibility testing results (irritation/sensitization) are also objective findings from laboratory tests, not expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the tests performed are objective laboratory measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is being assessed. This device is a medical glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product (medical glove), not an algorithm or AI software. The performance testing focuses on the physical properties and biological compatibility of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Standardized Measurement: Adherence to established performance standards defined by ASTM (American Society for Testing and Materials) such as D5250-06, D6124-06, and D5151-06.
- Laboratory Testing: Objective results from physical, chemical, and biological laboratory tests (e.g., tensile strength, elongation, residual powder measurement, water fill test for pinholes, primary skin irritation test, skin sensitization test).
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The testing performed is to validate the manufacturing process and product characteristics.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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