(99 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 disposable device intended for medical a 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, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (Reapproved 2005).
The acceptance criteria for the Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue, are based on adherence to ASTM standard D-6319-00a (Reapproved 2005) and FDA requirements for patient examination gloves.
Here's a breakdown of the acceptance criteria and performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Standard | ASTM D-6319-00a (Reapproved 2005) | Device meets all requirements of ASTM standard D-6319-00a (Reapproved 2005). |
| Physical and Dimensions Testing | Meets requirements based on ASTM D-6319-00a | All testing meets requirements for physical and dimensions testing conducted on gloves. |
| Freedom from Holes (Pinhole Test) | FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level G-1) | Water Fill Test conducted with samplings of AQL 2.5, inspection level G-1, meeting these requirements. |
| Biocompatibility - Primary Skin Irritation | No primary skin irritant reactions | Testing conducted with results showing no primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | Testing conducted with results showing no sensitization reactions. |
| Powder Residue (Powder-Free Claim) | No more than 2 mg powder per glove (based on ASTM D-6124-01 for Starch) | Residual Powder Test conducted to ensure gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| Labeling | No special labeling claims, no hypoallergenic claim | No special labeling claims and no claim of being hypoallergenic on labels. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For physical and dimensions testing, the inspection level was S-2, AQL 4.0. This indicates a sampling plan, but the exact number of gloves tested is not explicitly stated as a raw number. AQL (Acceptable Quality Limit) 4.0 refers to the maximum percentage of defective items that, for purpose of sampling inspection, can be considered satisfactory.
- For the FDA 1000 ml. Water Fill Test, the inspection level was G-1, AQL 2.5. Again, this is a sampling plan, not a raw number.
- For Biocompatibility (Primary Skin Irritation and Skin Sensitization) and the Residual Powder Test, specific sample sizes are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data beyond the manufacturer being in China. The study appears to be retrospective in the sense that it's a report of tests conducted on manufactured gloves to demonstrate compliance with standards. It's not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this device. The "ground truth" for examination gloves is established by objective performance against predefined technical standards (ASTM, FDA water fill test, biocompatibility protocols) rather than expert consensus on diagnostic images or clinical outcomes. The tests described are standardized laboratory and physical property tests.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., radiologists reviewing images) to resolve discrepancies. For objective tests on examination gloves, the results are quantitative measures or pass/fail criteria based on defined thresholds.
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
This is not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating AI performance in clinical diagnostic scenarios.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective technical standards and laboratory test results. This includes:
- Physical property measurements (e.g., dimensions, tensile strength, elongation, force at break) against ASTM D-6319-00a specifications.
- Absence of holes (pinholes) as determined by the FDA 1000 ml Water Fill Test.
- Biocompatibility (absence of primary skin irritation and sensitization) as determined by standardized in-vivo or in-vitro tests (methods not detailed beyond "testing conducted with results showing no primary skin irritant or sensitization reactions").
- Residual powder levels determined by ASTM D-6124-01.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI model. Its performance is demonstrated through adherence to established manufacturing and testing standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
§ 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.