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510(k) Data Aggregation
(152 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.
The following chemotherapy drugs have been tested on the glove:
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time |
|---|---|---|
| Carmustine* | 3.3 mg/mL | 23.2 min |
| Cisplatin | 1.0 mg/mL | >240 min |
| Cyclophosphamide | 20.0 mg/mL | >240 min |
| Dacarbazine | 10.0 mg/mL | >240 min |
| Doxorubicin HCL | 2.0 mg/mL | >240 min |
| Etoposide | 20.0 mg/mL | >240 min |
| Fluorouracil | 50.0 mg/mL | >240 min |
| Methotrexate | 25.0 mg/mL | >240 min |
| Paclitaxel | 6.0 mg/mL | >240 min |
| ThioTepa* | 10.0 mg/mL | 13.5 min |
| Mitomycin C | 0.5 mg/mL | >240 min |
| Vincristine Sulfate | 1.0 mg/mL | >240 min |
| Fentanyl | Concentration | Breakthrough Detection Time |
|---|---|---|
| Fentanyl Citrate | 100.0 mcg/2mL | >240 min |
*Please note that the following drugs have low permeation time.
- Carmustine
- ThioTepa
Warning: Do not use with Carmustine & ThioTepa
The proposed Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Polychloroprene. The gloves are not made with natural rubber latex. General specifications of the glove are as below:
- Overall Length: 240 mm minimum
- Width: 95 ± 5 mm minimum (for medium glove)
- Palm Thickness: 0.05 mm minimum
- Finger Thickness: 0.05 mm minimum
- Cuff Thickness: 0.05 mm minimum
- Tensile Strength
- a. Before Aging: 14 MPa minimum
- b. After Aging: 14 MPa minimum
- Ultimate Elongation
- a. Before Aging: 500 % minimum
- b. After Aging: 400 % minimum
- Pinhole AQL: 2.5
The provided FDA 510(k) clearance letter and associated documentation pertain to a Powder-Free Polychloroprene Examination Glove. This is a physical medical device, not an AI/software device. Therefore, the questions related to AI/software performance criteria (such as multi-reader multi-case studies, human-in-the-loop performance, training/test set ground truth, and expert adjudication) are not applicable to this documentation.
The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the gloves, and their resistance to permeation by chemotherapy drugs and fentanyl.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, focusing on the relevant physical device aspects:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Standard / Requirement | Device Performance (Proposed Device K250342) |
|---|---|---|
| Dimensions | ASTM D6977-19 | |
| Length (XS) | ≥ 220 mm | ≥ 251 mm |
| Length (S) | ≥ 220 mm | ≥ 250 mm |
| Length (M) | ≥ 230 mm | ≥ 251 mm |
| Length (L) | ≥ 230 mm | ≥ 248 mm |
| Length (XL) | ≥ 230 mm | ≥ 250 mm |
| Length (XXL) | ≥ 230 mm | ≥ 250 mm |
| Width (XS) | 70 ± 10 mm | 79 - 80 mm |
| Width (S) | 80 ± 10 mm | 86 - 88 mm |
| Width (M) | 95 ± 10 mm | 98 - 100 mm |
| Width (L) | 110 ± 10 mm | 111 - 113 mm |
| Width (XL) | 120 ± 10 mm | 115 - 118 mm |
| Width (XXL) | 130 ± 10 mm | 127 - 129 mm |
| Thickness (Finger) | ≥ 0.05 mm | ≥ 0.11 mm |
| Thickness (Palm) | ≥ 0.05 mm | ≥ 0.08 mm |
| Thickness (Cuff) | ≥ 0.05 mm | ≥ 0.06 mm |
| Freedom from Holes | ASTM D6977-19, 21 CFR 800.20 (AQL 2.5) | Passed (for all sizes XS-XXL) |
| Physical Properties | ASTM D6977-19 (ASTM D412-16, D573) | |
| Before Aging (Tensile) | ≥ 14 MPa | 16.83 - 33.4 MPa (depending on size) |
| Before Aging (Elongation) | ≥ 500 % | 521 - 596 % (depending on size) |
| After Aging (Tensile) | ≥ 14 MPa | 23.8 - 40.2 MPa (depending on size) |
| After Aging (Elongation) | ≥ 400 % | 428 - 462 % (depending on size) |
| Residual Powder | ASTM D6977-19, ASTM D6124-06 (≤ 2.0 mg/glove) | 0.22 - 0.32 mg/glove (depending on size) |
| Biocompatibility | ||
| Skin Irritation | ISO 10993-10 (Score ≤ 0.4) | Not considered an irritant |
| Skin Sensitization | ISO 10993-10 (Score 240 min | |
| Cyclophosphamide | - | >240 min |
| Dacarbazine | - | >240 min |
| Doxorubicin HCL | - | >240 min |
| Etoposide | - | >240 min |
| Fluorouracil | - | >240 min |
| Methotrexate | - | >240 min |
| Paclitaxel | - | >240 min |
| ThioTepa | - | 13.5 min* |
| Mitomycin C | - | >240 min |
| Vincristine Sulfate | - | >240 min |
| Fentanyl Permeation | ASTM D6978-05 (Minimum Breakthrough Detection Time) | |
| Fentanyl Citrate | - | >240 min |
*Note: The document explicitly warns that Carmustine and ThioTepa have low permeation times and should not be used with the glove. This is a crucial labeling instruction based on the test results.
2. Sample Size Used for the Test Set and Data Provenance
- The document does not explicitly state the specific sample sizes used for each physical, chemical, and permeation test. However, tests are typically performed on a statistically relevant number of samples to ensure representativeness and robust results according to the specified ASTM and ISO standards.
- Data Provenance: The tests appear to have been conducted by Encompass Industries Sdn. Bhd. or a contracted lab on their behalf. The company is located in Kertih Bio-Polymer Park, Kemaman, Terengganu, Malaysia. The data is prospective in the sense that the tests were specifically performed on the proposed device for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the document describes a physical medical device (examination glove) and its material/permeation performance, not a software/AI device that requires expert human interpretation of data for ground truth establishment. The "ground truth" for these tests is based on objective, standardized laboratory measurements (e.g., precise measurements of length, thickness, tensile strength; chemical analysis for powder residue; standardized biological assays for biocompatibility; and analytical chemistry for drug permeation breakthrough times).
4. Adjudication Method for the Test Set
- This question is not applicable for the same reason as point 3. Testing of physical device characteristics and chemical permeation is typically performed according to established laboratory protocols with quantitative, measurable endpoints, not through a process of 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
- This question is not applicable as the document describes a physical medical device (examination glove), not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the document describes a physical medical device (examination glove), not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of the examination gloves is based on objective, standardized laboratory measurements and adherence to established international and national standards (e.g., ASTM D6977-19, ASTM D6319-19, ASTM D5151-19, ASTM D412-16, ASTM D573, ASTM D6124-06, ASTM D6978-05, ISO 10993-10, ISO 10993-11, 21 CFR 800.20).
- Examples include:
- Physical measurements: Direct measurement of glove dimensions (length, width, thickness).
- Mechanical properties: Tensile strength and elongation determined by standard material testing methods.
- Integrity: Freedom from holes determined by water leak testing (ASTM D5151-19).
- Chemical analysis: Measurement of residual powder.
- Biocompatibility: In-vivo (skin irritation, sensitization, acute systemic toxicity) tests using animal models, following ISO standards.
- Permeation: Breakthrough detection time of specific chemotherapy drugs and fentanyl using analytical methods (ASTM D6978-05).
- Examples include:
8. The Sample Size for the Training Set
- This question is not applicable as the document describes a physical medical device, which does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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