(23 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 containation between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all 21 C requirements of ASTM standard D-5250-00E4.
This document describes the 510(k) summary for Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, White. The summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM D-5250-00E4 Standard (Physical & Dimensions) | All testing meets requirements for physical and dimensions testing conducted on gloves. |
| FDA 1000 ml Water Fill Test (Pinhole) | Sampling conducted at AQL 2.5, inspection level I, meeting requirements. |
| Primary Skin Irritation | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Testing conducted with results showing no sensitization reactions. |
| Residual Powder (ASTM D-6124-06 for Starch) | Testing conducted to ensure gloves meet "powdered" claims (contain no more than 10mg/dm2). |
2. Sample Size Used for the Test Set and Data Provenance
The document provides the following information:
- ASTM D-5250-00E4 (Physical & Dimensions): "Inspection level S-2, AQL 4.0." This refers to sampling plans defined within the ASTM standard. The specific sample size is not explicitly stated in the provided text but would be determined by these parameters.
- FDA 1000 ml Water Fill Test (Pinhole): "Samplings of AQL 2.5, inspection level I." Similar to the above, this indicates the sampling plan, but the exact numerical sample size is not presented.
- Primary Skin Irritation and Skin Sensitization: The document doesn't specify sample sizes for these tests.
- Residual Powder Test: The document doesn't specify sample size for this test.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Shijiazhuang, Hebei, China), the testing was likely conducted in China. The document does not specify if the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, water fill tests, chemical tests, biocompatibility tests). They do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic imaging study would.
4. Adjudication Method for the Test Set
Not applicable, as the tests are objective and do not require expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for personal protection (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Established ASTM Standards: For physical properties, dimensions, and residual powder content. These standards define objective criteria and test methods.
- FDA Requirements: For the pinhole test (1000 ml Water Fill Test).
- Biocompatibility Testing Protocols: For primary skin irritation and skin sensitization, which involve established biological assessment methods.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a series of non-clinical tests conducted on the Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, White. These tests were designed to demonstrate compliance with recognized industry standards and regulatory requirements for patient examination gloves.
The key aspects of this study include:
- Compliance with ASTM D-5250-00E4: The gloves were tested for physical and dimensional characteristics, with all results meeting the requirements of this ASTM standard. The sampling plan for these tests was based on "Inspection level S-2, AQL 4.0."
- Pinhole Integrity (FDA 1000 ml Water Fill Test): The gloves underwent the FDA 1000 ml Water Fill Test, meeting the requirements with a sampling plan of "AQL 2.5, inspection level I."
- Biocompatibility Testing:
- Primary Skin Irritation: Tests were conducted, showing no primary skin irritant reactions.
- Skin Sensitization (Allergic Contact Dermatitis): Tests were conducted, showing no sensitization reactions.
- Residual Powder Content: A Residual Powder Test based on ASTM D-6124-06 was performed to ensure the gloves meet the "powdered" claim, meaning they contain no more than 10mg/dm2 of starch.
The conclusions of these tests collectively demonstrated that the device "conform[s] fully to ASTM D-5250-00E4 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims." The results provided the basis for the FDA's determination of substantial equivalence to the predicate device.
§ 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.