(100 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
These gloves are tested for use with Chemotherapy Drugs.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21CFR 880.6250, Patient Examination Glove 80 LZA, and meets all requirements of ASTM Standard D6319-00a e3
Here's a summary of the acceptance criteria and the study details for the Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove:
1. Acceptance Criteria and Reported Device Performance:
The device's performance is primarily assessed against the requirements of ASTM Standard D6319-00a £3 (later referenced as ASTM D6319-00ae3-2001) for patient examination gloves and specific permeation testing for chemotherapy drugs per ASTM D 6978-05. The table below combines the acceptance criteria (implied by the ASTM standards and "Passes" results) with the reported device performance.
| Characteristic / Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material/Construction | Nitrile, Powder-Free | Nitrile, Powder-Free |
| Dermal Sensitization Test | Passes (no sensitization) | Passes |
| Primary Skin Irritation Test | Passes (no primary irritation) | Passes |
| Permeation testing per ASTM D 6978-05 (Chemotherapy Drugs) | Passes (meets specific permeation limits for chemotherapy drugs) | Passes |
| Water Leak Test (Pinholes) | AQL 2.5 (ASTM D6319-00ae3) | Passes (meets requirements of ASTM D6319-00ae3), AQL 2.5 pinholes |
| Dimensions (Length) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Width) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Thickness - Palm) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Dimensions (Thickness - Finger) | Meets requirements of ASTM D6319-00ae3 | Meets requirements of ASTM D6319-00ae3 |
| Tensile Strength (pre-aging min) | 14 MPa (ASTM D6319-00ae3) | 14 MPa |
| Tensile Strength (after-aging min) | 14 MPa (ASTM D6319-00ae3) | 14 MPa |
| Ultimate Elongation (pre-aging min) | 500 % (ASTM D6319-00ae3) | 500 % |
| Ultimate Elongation (after-aging min) | 450 % (ASTM D6319-00ae3) | 450 % |
| Biocompatibility | Meets standards ("Yes", "Limited" duration) | Yes, Limited duration |
| Residual Powder Test | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Physical/Performance Tests (Water Leak, Dimensions, Tensile Strength, Elongation): "Inspection level S-2, AQL 4.0 pinholes at AQL 2.5" is mentioned. This refers to the sampling plan within ASTM D6319-00ae3. It's a standard statistical sampling plan, but the exact number of gloves tested is dependent on the batch size and the specific inspection level and AQL. The document does not provide the explicit sample count.
- Sample Size for Biocompatibility Tests (Dermal Sensitization, Primary Skin Irritation): Not explicitly stated in the document. These tests typically involve a limited number of human subjects or animal models, but specific numbers are not provided.
- Sample Size for Permeation Testing: Not explicitly stated, but ASTM D6978-05 outlines specific requirements for the number of glove samples and the duration of testing with various chemotherapy drugs.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the submitter is Dynarex Corporation (USA). The testing would have been conducted to international standards (ASTM) generally accepted in the US for regulatory submission. The device description mentions the predicate device is from "Shijiazhuang Tillotson Rubber Products Co., Ltd., China," which suggests some manufacturing or relationship there, but the testing itself is submitted by the US company. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of device (patient examination glove) does not typically involve "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth. The "ground truth" for the performance criteria is defined by the ASTM standards themselves (D6319-00ae3 and D6978-05), which are developed by expert consensus in the field. The results are then objectively measured against the specified thresholds within these standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of this device. Performance is measured against objective, predefined parameters in ASTM standards, not through subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a physical barrier, not an interpretative AI device where human readers interact with AI for diagnostic tasks.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical product, not a software algorithm. The "performance" is its physical and chemical properties and barrier integrity.
7. Type of Ground Truth Used:
The ground truth used is based on established industry standards and objective measurements. Specifically:
- Physical properties (dimensions, tensile strength, elongation) are measured objectively against thresholds defined in ASTM D6319-00ae3.
- Barrier integrity (water leak test for pinholes) is measured objectively against AQL levels defined in ASTM D6319-00ae3.
- Biocompatibility (dermal sensitization, irritation) is assessed through standardized tests with predefined pass/fail criteria.
- Chemotherapy drug permeation is determined objectively by measuring drug breakthrough times and rates as per ASTM D6978-05.
8. Sample Size for the Training Set:
Not applicable. This device is a manufactured product, not a machine learning model. There is no concept of a "training set" for the purpose of this 510(k) submission. Manufacturing processes are subject to quality control, which involves ongoing testing, but this isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning model.
§ 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.