(29 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION between patient and EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ., and meets all requirements of ASTM Standard D5250-00E4.
The provided text is a 510(k) summary for a disposable powdered vinyl exam glove. It outlines the device's characteristics and its equivalence to a predicate device but does not contain the details of a study that proves the device meets specific acceptance criteria in the way a clinical study for a diagnostic or therapeutic device would.
Instead, the "acceptance criteria" here relate to compliance with established industry standards and regulatory requirements for medical gloves. The "study" refers to the non-clinical tests performed to demonstrate this compliance.
Here's the information broken down based on your request, with an emphasis on what is (and isn't) available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements per ASTM D5250-00E4 (Inspection level S-2, AQL 4.0) |
| Watertight Test (Pinhole): | Meets requirements per FDA 1000 ml Watertight Test based on ASTM D-5151-99 (Samplings of AQL 2.5, Inspection level I) |
| Primary Skin Irritation: | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions |
| Material/Construction: | Vinyl Examination Glove, Powdered, Yellow Color (Equivalent to predicate K932054, with color additive difference) |
| Biocompatibility: | Meets biocompatibility requirements (Implied by skin irritation/sensitization results) |
| Labeling Claims: | Meets labeling claims (No hypoallergenic claim made) |
| Regulatory Compliance: | Conforms fully to ASTM D-5250-00E4 standard and applicable 21 CFR references (e.g., 21 CFR 880.6250) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The exact number of gloves tested is dependent on lot size and the AQL tables, which are not specified here.
- For Watertight Test: "Samplings of AQL 2.5, Inspection level I". Similar to above, the exact number tested is not specified but determined by AQL tables and lot size.
- For Primary Skin Irritation and Skin Sensitization: Not specified, but typically involves a certain number of animal subjects (e.g., guinea pigs) or human volunteers for patch tests.
- Data Provenance: Not explicitly stated, but given the submitter is from Vietnam ("Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, Vietnam") and the tests were performed "for Ever Global Enterprise Corporation's glove production," it's highly likely the testing was conducted by or for the manufacturer in their facilities or contracted labs, possibly within Vietnam, specifically for this device. The data is prospective with respect to the regulatory submission, as it was generated to support the 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a Class I medical glove. The "ground truth" for its performance is based on adherence to established consensus standards (ASTM) and regulatory tests (FDA watertight test, biocompatibility). These standards define objective pass/fail criteria, rather than requiring expert consensus on subjective interpretations (like reading medical images). The experts involved would be laboratory technicians and quality assurance personnel following standard protocols, not medical specialists establishing clinical ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the tests are objective and follow predefined methodologies from ASTM and FDA. They do not involve subjective interpretation requiring an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images) and the AI's impact on their performance (e.g., accuracy, efficiency) is measured. This device is a physical barrier (glove), not a diagnostic tool, so an MRMC study is not relevant or applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical product (glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" here is defined by established consensus standards and objective test methodologies:
- ASTM D5250-00E4: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard defines physical properties and dimensions.
- ASTM D-5151-99: Standard Test Method for Detection of Holes in Medical Gloves. This defines the watertight test.
- Biocompatibility testing guidelines: These would define the methodology for primary skin irritation and sensitization tests.
- The device's performance is measured against these objective, predefined criteria.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The manufacturing process of gloves involves quality control and process validation, which might involve large amounts of data, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the glove's manufacturing refers to the product specifications and quality standards that the manufacturing process aims to meet.
§ 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.