(203 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 D5250-92.
This document describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through its conformance to established standards and tests for examination gloves.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Conformance to ASTM D5250-92, Inspection Level S-2, AQL 4.0 | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 4.0. |
| Pinhole / Water Leak Test: Conformance to FDA 1000 ml. Water Fill Test, sampling AQL 2.5, Inspection Level S-4 | The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Primary Skin Irritation: No significant primary skin irritant reactions | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): No significant sensitization reactions | Testing conducted with results showing no sensitization reactions. |
| Powder-Free Claim: Absence of starch as per USP Iodine Test | A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodology and testing conducted revealed passing results. |
| Biocompatibility: No adverse reactions (based on irritation and sensitization tests) | Biocompatibility requirements met as shown by data in Section 7 (Primary Skin irritation and Skin Sensitization testing). |
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size:
- For Physical and Dimensions Testing: Inspection Level S-2.
- For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, Inspection Level S-4.
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but standard biocompatibility testing involves a statistically relevant number of subjects/samples.
- For USP Iodine Test: Routinely performed at finished inspection; specific sample size per batch not provided.
-
Data Provenance: The studies were conducted by the device manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd., based in P.R. China. The studies are retrospective relative to the submission date, as they were performed to demonstrate compliance of existing product batches.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is a medical glove, and the "ground truth" for its performance is established by objective, standardized laboratory and materials testing, not by expert interpretation of medical images or conditions. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The "experts" involved would be qualified laboratory technicians and material scientists who conduct the tests according to published ASTM and FDA standards. Specific numbers or qualifications of these individuals are not provided in the summary.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic assessments, particularly in imaging studies. For this device, the tests are primarily objective measurements against predefined thresholds set by ASTM standards and FDA guidelines (e.g., AQL levels for pinholes, pass/fail for irritation). Therefore, an adjudication method for conflicting expert opinions is not applicable. The results are quantitative or clearly pass/fail.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's effect on human performance is being evaluated. This device is an examination glove, which does not involve human interpretation in the same way.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The document describes several tests performed directly on the device (the gloves) to demonstrate its intrinsic properties and compliance with standards, independent of human interaction for interpretation purposes. These include:
- Physical and Dimensions Testing against ASTM D5250-92.
- FDA 1000 ml. Water Fill Test (for pinholes).
- Primary Skin Irritation testing.
- Skin Sensitization testing.
- USP Iodine Test for starch.
7. Type of Ground Truth Used
The ground truth used is primarily objective performance metrics and compliance with established industry standards and regulatory requirements. This includes:
- ASTM Standard D5250-92: For physical properties and dimensions.
- FDA 1000 ml. Water Fill Test requirements: For pinhole integrity.
- Biocompatibility guidelines: For primary skin irritation and sensitization.
- USP Iodine Test methodology: For confirming "powder-free" claims.
These are well-defined, quantitative, or qualitative pass/fail criteria, rather than subjective expert consensus or pathology interpreted from patients.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product (medical glove) and does not employ an AI algorithm or machine learning. Therefore, there is no training set in the context of AI development. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, there is no training set for an AI algorithm. The manufacturing process and quality control for the gloves are based on established manufacturing specifications, material science principles, and quality assurance protocols that ensure the product consistently meets the performance standards outlined in Section 7.
§ 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.