(84 days)
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, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06el.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets those criteria:
Acceptance Criteria and Device Performance for Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove (K092296)
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines an equivalency study based on established ASTM standards and FDA requirements rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are therefore the requirements set by the cited standards for this device type.
| Acceptance Criteria (Set by Standards) | Reported Device Performance (as per submission) |
|---|---|
| Physical and Dimensions Testing: | |
| (Based on ASTM D-5250-06e1) | All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0. |
| Pinholes (Water Fill Test): | |
| (FDA 1000 ml. Water Fill Test AQL 2.5, inspection level 1) | The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, inspection level 1, meeting these requirements. |
| Biocompatibility (Primary Skin Irritation): | Primary Skin Irritation testing was conducted with results showing no primary skin irritant reactions. |
| Biocompatibility (Skin Sensitization/Allergic Contact Dermatitis): | Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitization reactions. |
| Residual Powder: | |
| (Based on ASTM D-6124-06) | A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove). |
| Labeling Claims (Hypoallergenic): | No claim of hypoallergenic is made. |
| Overall Conformity: | Conform fully to ASTM D-5250-06e1 standard as well as applicable 21 CFR references. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The specific numerical sample size is not explicitly stated but is implicitly defined by the AQL (Acceptance Quality Limit) and inspection level (S-2) within Quality Assurance sampling plans, likely based on ANSI/ASQ Z1.4 (or equivalent) tables.
- Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level 1". Similar to above, the specific numerical sample size is not explicitly stated, but defined by AQL and inspection level. This is a common sampling plan for medical gloves.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): The specific sample size (e.g., number of test subjects or animals) is not provided.
- Residual Powder Test: The specific sample size is not provided, but it's stated to be conducted "at finished inspection."
Data Provenance: The document does not explicitly state the country of origin for the data collection for these tests. However, the submitter is "Better Care Plastic Products Co., Ltd." from "Hebei Province 050000" in China, suggesting the testing was likely conducted in or contracted by the manufacturing company in China, following international standards. The tests are retrospective, performed on manufactured products.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This submission describes pre-market testing for a Class I medical device (patient examination glove), which relies on objective performance measurements against established standards, not expert consensus on interpretations of complex data (like image analysis). Therefore, the concept of "experts establishing ground truth for the test set" in the context of, for example, multiple radiologists reviewing images, does not directly apply here.
The "ground truth" for glove performance is defined by the objective metrics and thresholds specified in the ASTM standards (D-5250-06e1, D-6124-06) and FDA test methods (1000 ml. Water Fill Test). The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel who are trained in performing these specific tests and interpreting the results according to the published standards. Their qualifications would involve training in laboratory procedures, statistical quality control, and knowledge of the relevant ASTM and FDA guidelines for medical device testing.
4. Adjudication Method for the Test Set:
Adjudication methods like "2+1" or "3+1" are typically used when there's subjective interpretation involved, such as clinical reads or image analysis, where multiple experts might disagree. In this case, the tests are objective:
- Physical dimensions are measured.
- Pinhole tests are pass/fail based on water leakage.
- Irritation/sensitization tests are based on observed reactions or lack thereof.
- Residual powder is measured quantitatively.
Therefore, a formal "adjudication method" in the sense of reconciling differing expert opinions is not applicable. The results are directly derived from the test protocols. Any potential disputes would arise from re-testing, calibration, or auditing of the testing facility, not from subjective expert disagreement on the outcome of a particular test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the goal is to assess how a new technology (e.g., AI) impacts human performance. A patient examination glove is a simple physical barrier device, and its safety and effectiveness are assessed through physical, chemical, and biological testing as described, not by human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable as the device is a physical product (a glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth used for demonstrating compliance is objective performance data derived from standardized laboratory tests and measurements. This includes:
- Physical Measurements: Tensile strength, elongation, dimensions, etc., against ASTM D-5250-06e1 specifications.
- Leakage/Barrier Integrity: Pass/fail rates for the FDA 1000 ml. Water Fill Test.
- Biocompatibility Data: Results from primary skin irritation and skin sensitization tests (e.g., absence of observed reactions).
- Chemical Analysis: Quantitative measurement of residual powder against ASTM D-6124-06 and the "
§ 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.