(34 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
Warning: do not use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
- Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
- Thiotepa 10.0 mg/ml 13.6 minutes
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."
This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.
The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.
Here's the breakdown of the relevant information from the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).
| Test | Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | Determine the geometrical dimension of gloves | Length: Short cuff: ≥230mm; Long cuff: ≥300mm | |
| Thickness: Palm: ≥ 0.05 mm; Finger: ≥ 0.05 mm; Cuff: ≥ 0.05 mm | ||||
| Palm Width: XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | Pass | |||
| Freedom from holes (Water leak) | 21 CFR 800.20. & ASTM D5151-19 | Detect the holes on the gloves. | G-I/ AQL 2.5 | Pass |
| Tensile strength (Before aging/ After aging) | ASTM D6319-19 | Evaluate the tensile (tension) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves. | Before Aging: ≥14MPa | |
| After Aging: ≥14MPa | Pass | |||
| Elongation (Before aging/ After aging) | ASTM D6319-19 | Related to tensile properties, measures stretchiness. | Before Aging: ≥500% | |
| After Aging: ≥400% | Pass | |||
| Powder Residual | ASTM D6319-19 | Determine the average powder mass found on the gloves | ＜ 2mg per glove | Pass |
| Biocompatibility - Cytotoxicity | AAMI/ANSI/ISO 10993-5 | Determine the cytotoxicity potential of glove | No in vitro cytotoxic as described in ISO 10993-5 | Pass |
| Biocompatibility - Skin Sensitization and Irritation | AAMI/ANSI/ISO 10993-10 | Determine the potential of glove to promote skin sensitization after repeated applications. | ||
| Determine the potential of gloves to promote skin irritation after repeated applications. | No dermal reactions indicative of delayed contact hypersensitivity | |||
| No skin irritation, cumulative irritation index to be 0. | Pass | |||
| Resistance of Gloves to Permeation by Chemotherapy and Other Liquid Hazardous Drugs, and Non-drugs Solution | ASTM D6978-05 | Assessment of medical gloves to permeation by chemotherapy and other liquid hazardous drugs, and non-drugs solution. | The resistance of the device to permeation were challenged against 59 hazardous drugs and 1 non-drugs simulated solution. | |
| General Acceptance Standard (Implicit): Maintain barrier protection for a minimum period. The tables on pages 4-5 and 7-11 list Minimum Breakthrough Detection Time (Min.) for each substance. For most substances, the acceptance criterion was ">240 minutes", meaning no breakthrough occurred within the 240-minute test period. For Carmustine and Thiotepa, specific breakthrough times (21.5 and 13.6 minutes, respectively) were observed and noted as limitations/warnings. | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
- Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human 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. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
- For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
- For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
- For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.
8. The sample size for the training set:
- Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this physical 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.