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510(k) Data Aggregation
(105 days)
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)". It outlines the device's characteristics, indications for use, and a comparison to a predicate device, focusing on non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance.
The document provides multiple tables summarizing the performance and comparison of the proposed device to predicate devices. The primary table serving this purpose is "Table 3 Performance comparison" and the table that includes "Test Method," "Purpose," "Acceptance Criteria," and "Results" on Page 13.
| Test/Characteristic | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Before Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 500%, min | Tensile strength: 14MPa, min; Ultimate elongation: 500%, min (Implied "Pass" based on overall result) |
| After Aging | Tensile strength: ≥14 MPa, min; Ultimate elongation: 400%, min | Tensile strength: 14MPa, min; Ultimate elongation: 400%, min (Implied "Pass" based on overall result) |
| Freedom from Holes (ASTM D5151-19) | No leakage at sampling level of G-1, AQL 2.5 | Pass |
| Residual Powder (ASTM D6124-06 (2022)) | <2mg per glove | Pass |
| Dimensions (ASTM D6319-19) | Length: 240mm min | Pass |
| Palm Width (XS) | 70±10mm | Pass (70±10) |
| Palm Width (S) | 80±10mm | Pass (80±10) |
| Palm Width (M) | 95±10mm | Pass (95±10) |
| Palm Width (L) | 110±10mm | Pass (110±10) |
| Palm Width (XL) | 120±10mm | Pass (120±10) |
| Palm Width (XXL) | 130±10mm | Pass (130±10) |
| Thickness (Finger) | ≥0.05 mm | Pass |
| Thickness (Palm) | ≥0.05 mm | Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) & Fentanyl | Refer to Table 4 for specific breakthrough detection times for each drug. The primary acceptance criteria for most drugs is >240 minutes, with specific, lower times for Carmustine (13.2 min) and Thiotepa (13.1 min). | The reported results in Table 4 (pages 10-11) match the acceptance criteria for each drug, indicating "Pass" or "Same". For Carmustine (13.2 min) and Thiotepa (13.1 min), the results are noted as "Similar" to the predicate, with explicit warnings not to use with these drugs due to low permeation times. |
| Biocompatibility | Irritation (ISO 10993-23): Not an irritant. | Under the conditions of the study, not an irritant. |
| Sensitization (ISO 10993-10): Not a sensitizer. | Under the conditions of the study, not a sensitizer. | |
| Acute Systemic Toxicity (ISO 10993-11): Device extract does not induce acute systemic toxicity reaction. | Under the conditions of the study, the device extract does not induce acute systemic toxicity response. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
The document does not specify the exact sample sizes used for each physical or chemical test. It references ASTM standards, which would typically define sampling plans. For instance, for Freedom from Holes, it mentions "sampling level of G-1, AQL 2.5," which refers to specific statistical sampling plans within ASTM D5151, but not the explicit number of gloves tested.
The data provenance is from non-clinical tests conducted to relevant ASTM and ISO standards. The Applicant, Shandong Xingyu Gloves Co., Ltd., is located in China, suggesting the tests were likely conducted there or by affiliated labs. The testing appears to be prospective as it was done specifically to evaluate the performance of this new device for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).
This document describes a device (gloves) and its performance under various physical and chemical stress tests, not imaging or diagnostic AI. Therefore, the concept of "experts establishing ground truth" in the medical image interpretation sense (e.g., radiologists) is not applicable here. The "ground truth" for the performance claims (e.g., tensile strength, breakthrough time) is established by adherence to the specified and validated ASTM and ISO laboratory test methods and their defined measurement protocols. The experts involved would be the qualified laboratory technicians and chemists performing these standardized tests. Their qualifications are implicitly that they are capable of performing these standardized tests correctly.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving subjective human interpretation of data (e.g., medical images), where disagreements between readers need to be resolved by a third or fourth expert. Since this document describes non-clinical, objective laboratory testing of physical and chemical properties, an adjudication method as typically understood in a multi-reader clinical study is not applicable. The results are directly measured by instruments and adherence to test protocols.
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.
No, an MRMC comparative effectiveness study was not conducted. This is a 510(k) submission for medical gloves, based on non-clinical performance testing against established standards, not a diagnostic AI device requiring human reader interaction studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The "ground truth" for this device's performance claims is based on objective measurements obtained through standardized laboratory test methods (ASTM and ISO standards). For example:
- Physical properties (tensile strength, elongation): Measured in a lab according to ASTM D6319.
- Freedom from holes: Tested by inflation or water leak methods per ASTM D5151.
- Residual powder: Measured gravimetrically per ASTM D6124.
- Permeation by chemotherapy drugs/Fentanyl: Measured chromatographically by detecting breakthrough according to ASTM D6978.
- Biocompatibility: Evaluated in in vitro or in vivo models for specific biological endpoints (irritation, sensitization, systemic toxicity) following ISO 10993 standards.
The ground truth is therefore defined by the quantitative and qualitative results of these standardized, validated test procedures.
8. The sample size for the training set.
There is no training set mentioned or implied because this is not an AI/machine learning device. The device's performance is demonstrated through standard laboratory testing, not by training a model on a dataset.
9. How the ground truth for the training set was established.
As there is no training set, this question is not applicable.
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(57 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Average Result) | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 120 mmHg for Level 2 | Level 2: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested) | PASS |
| (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | Level 3: 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested) | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Level 2: 99.2% (3 non-consecutive lots tested) | PASS |
| (ASTM F2299) | Level 3: 99.5% (3 non-consecutive lots tested) | PASS | |
| Bacterial Filtration Efficiency | ≥ 98% | Level 2: 99.3% (3 non-consecutive lots tested) | PASS |
| (ASTM F2101) | Level 3: 99.3% (3 non-consecutive lots tested) | PASS | |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Level 2: 5.0 mmH2O/cm² (3 non-consecutive lots tested) | PASS |
| (EN 14683 Annex C) | Level 3: 4.4 mmH2O/cm² (3 non-consecutive lots tested) | PASS | |
| Flammability | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested) | PASS |
| (16 CFR 1610) | Level 3: Class 1 (3 non-consecutive lots tested) | PASS | |
| Biocompatibility - Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance Performance (ASTM F1862): 32 samples per lot, tested across 3 non-consecutive lots.
- Particulate Filtration Efficiency (ASTM F2299): 32 samples per lot, tested across 3 non-consecutive lots.
- Bacterial Filtration Efficiency (ASTM F2101): 32 samples per lot, tested across 3 non-consecutive lots.
- Differential Pressure (EN 14683 Annex C): 32 samples per lot, tested across 3 non-consecutive lots.
- Flammability (16 CFR 1610): 32 samples per lot, tested across 3 non-consecutive lots.
- Biocompatibility (ISO 10993-5, ISO 10993-10): The document does not specify the exact sample size for biocompatibility testing, but it was conducted on the mask materials (nose clip and ear loops components were specifically mentioned).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they were "non-clinical tests conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The tests performed are objective performance tests on the medical device itself (face mask), not assessments requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are objective laboratory performance tests with defined pass/fail criteria, not subjective assessments requiring 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:
- No MRMC comparative effectiveness study was done. This medical device is a face mask, and the submission focuses on its physical and biological performance characteristics, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a medical face mask, not an algorithm or software. All performance tests are on the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established scientific and regulatory standards (e.g., ASTM F2100-19, EN 14683, ISO 10993). Compliance is determined by objective measurements against these standards.
8. The sample size for the training set:
- This information is not applicable. This is a medical face mask, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons mentioned above.
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