(102 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 Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.
Important Note: The provided document is a 510(k) summary for a medical device (patient examination gloves). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove a new therapeutic effect. Therefore, the information typically requested in your prompt regarding clinical studies, human reader comparisons, and detailed ground truth establishment methods for complex algorithms is not applicable to this device. The "study" here refers to non-clinical performance testing.
Acceptance Criteria and Reported Device Performance
The device is a non-sterile, powder-free nitrile patient examination glove. Its acceptance criteria are based on compliance with established industry standards and regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical and Dimensions | ASTM D6319-05 | Meets requirements |
| Pinholes (Barrier Integrity) | FDA 1000 ml. Water Fill Test | Meets requirements (AOL 2.5, Inspection Level I) |
| Biocompatibility | Primary Skin Irritation Test | No primary skin irritant reactions |
| Skin Sensitization Test | No sensitization reactions (allergic contact dermatitis) | |
| Powder Residue | "Powder-free" claim | Contains no more than 2 mg powder per glove |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For Physical and Dimensions Testing and the FDA 1000 ml. Water Fill Test, an Inspection Level S-2 and Inspection Level I, respectively, with an AQL (Acceptable Quality Limit) of 2.5 was used. The exact numerical sample size for each batch tested is not explicitly stated but is determined by the AQL and inspection level standards (e.g., ISO 2859-1 or ANSI/ASQ Z1.4 for attributes sampling plans). For biocompatibility, the sample size is also not explicitly stated, but it would typically involve animal or in vitro testing.
- Data Provenance: The tests were performed by Zibo Yingbo Medical Products Co., Ltd. on their own products. The country of origin of the data is China, where the manufacturer is located. The testing is prospective in the sense that it's performed on manufactured glove batches to ensure ongoing quality and compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept is not applicable to the type of device and testing described. Ground truth for glove performance is established through objective, reproducible physical and chemical tests (e.g., tensile strength, elongation, water leak, powder residue, biocompatibility studies), not human expert consensus on interpretations.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication typically refers to resolving disagreements among human experts in interpreting data. The tests performed are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. For patient examination gloves, the "effectiveness" is primarily determined by barrier protection, strength, and biocompatibility, which are measured objectively.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable. This device is not an algorithm or AI system. It is a physical medical device (gloves). The performance tested is the standalone performance of the gloves themselves.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Industry Standards: Adherence to ASTM D6319-05 (Standard Specification for Nitrile Examination Gloves for Medical Application).
- Regulatory Requirements: Compliance with the FDA 1000 ml. Water Fill Test for pinholes, indicating barrier integrity.
- Biocompatibility Standards: Results from primary skin irritation and skin sensitization tests demonstrating safety for skin contact.
- Manufacturing Specifications: Ensuring powder residue meets the "powder-free" claim (less than 2 mg/glove).
These are objective, measurable criteria.
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" in the context of a physical medical device like gloves. Training sets are used in machine learning for AI systems.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set.
§ 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.