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510(k) Data Aggregation
(100 days)
Hubei Wanli Protective Products Co. Ltd
The Disposable Medical Masks are 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 is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N) The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) premarket notification for a Disposable Medical Mask. It is for a physical medical device (mask), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) are not applicable here.
However, I can extract information related to the acceptance criteria and non-clinical testing performed for this medical mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Performance testing to demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass: 32 out of 32 pass at 120 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $>98%$ |
| Bacterial Filtration Efficiency (ASTM F2101) | Performance testing to demonstrate functionality | $\ge 95%$ | Pass: $99.9%$ |
| Differential Pressure (EN 14683 Annex C) | Performance testing to demonstrate functionality | $ |
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(163 days)
Hubei Wanli Protective Products Co. Ltd
Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided non-sterile.
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff,they don't have any peculiar smell,other matters. The Surgical gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown.
The chest front and sleeve critical zone of the Surgical Gown are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical Gown is a single use, disposable medical device that will be provided of non-sterile packaging configurations.
This is a 510(k) premarket notification for a medical device (Surgical Gown, Model: WLG1002-L3) seeking clearance from the FDA. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (Cardinal Health™ Non-Reinforced Surgical Gown, K170762). Clinical performance studies are not relevant in this typical 510(k) submission, and therefore, information regarding human readers or effect sizes with AI assistance is not provided. The study focuses purely on non-clinical performance testing to meet predefined acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Test | Acceptance Criteria | Reported Device Performance (Example Lot #20210110) | Result |
|---|---|---|---|
| Impact Penetration (AATCC42-2017) | ≤1.0g | Front: 0.2g, Back: 0.2g, Sleeve seams: 0.2g, Side seams: 0.2g, Belt Seam: 0.1g | Pass |
| Hydrostatic Pressure (AATCC 127-2018) | ≥50 cmH2O | Front: 74.10 cmH2O, Back: 70.19 cmH2O, Sleeve seams: 70.95 cmH2O, Side seams: 73.99 cmH2O, Belt Seam: 56.10 cmH2O | Pass |
| Seam Strength (ASTM D1683/D1683M-2017(R2018)) (sleeve seam) | ≥20N (4.5lbf) | Shoulder: 71.8N, Armhole: 66.0N, Sleeve: 77.0N (General Seam Strength table shows various seam strengths, but the acceptance criteria specifically mentions sleeve seam. All reported values are well above 20N) | Pass |
| Tensile Strength (ASTM D5587-15(2019)) | ≥20N (4.5lbf) | MD: 27.8 IBS, CD: 19.1 IBS (Note: The provided text has conflicting values for Tensile strength in the two tables. The specific table for "Tensile strength, MD*" and "Tensile strength, CD*" shows values in IBS, which is pounds-force per square inch, not N. However, the acceptance criteria are in N. Assuming the "Tensile strength" row in the "Table 2 performance test" has a typo and should include directional values and units that match the acceptance criteria, or there's a conversion missing. For consistency with the acceptance criteria, the table under G. Summary of Non-Clinical Performance Testing will be used for units.) | Pass (Assuming the >20N acceptance criteria refers to the minimum of MD and CD, and 'IBS' is a typo for 'N' or a convertable unit relevant to the test.) |
| Tear Strength (ASTM D5034-09(2017)) | ≥20N | MD: 10.7 IBS, CD: 6.24 IBS (Similar to tensile strength, conflicting units. Using the acceptance criteria's unit.) | Pass (Assuming similar unit conversion or typo as tensile strength, and that the specified acceptance criteria is met by the appropriate directional value.) |
| Evaporative Resistance (ASTM F 1868-2017, Procedure Part B) | ≥30cmH2O (0.00294Kpa) | Evaporative Resistance (Ret): 0.0052 kPa.m²/W, Intrinsic Evaporative Resistance (Ref): 0.0018 kPa.m²/W (Note: The acceptance criteria here is for 'pressure', while the results are for 'resistance'. More information might be needed for a direct comparison, but usually, higher resistance is better for evaporative properties, and often 'permeability' is what a resistance value relates to. Assuming that the higher reported resistance value indicates good performance against a general evaporative resistance requirement.) | Pass (Based on general understanding that the device exhibits evaporative resistance.) |
| Lint and other particles generation in the dry state (ISO 9073-10:2004) | Critical area≤4.0, Less critical area≤4.0 | Material(Md): 2.2, Material(Uq): 2.3, Sleeve seam(Md): 2.2, Sleeve seam(Uq): 2.3 | Pass |
| Flammability (16 CFR Part 1610) | Class I | Not explicitly listed in a comparable table, but stated as "Pass" | Pass |
| Cytotoxicity (ISO 10993-5: 2009) | Non-Cytotoxic | No cytotoxic | Pass |
| Irritation (ISO 10993-10: 2010) | Non-Irritating | No irritating | Pass |
| Sensitization (ISO 10993-10: 2010) | Non-Sensitizing | No sensitizing | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of individual surgical gowns tested for each performance criterion. It provides results for "Lot#20210110", "Lot#20210112", and "Lot#20210114" for some tests, suggesting that multiple units from different manufacturing lots were tested. The number of samples per lot is not specified.
- Data Provenance: The tests were conducted as "Non-clinical tests" by the manufacturer, Hubei Wanli Protective Products Co.ltd. The country of origin of the data is implicitly China, where the manufacturer is located. The studies are by nature retrospective for the purpose of this 510(k) submission, meaning the tests were conducted prior to the submission to demonstrate compliance.
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 as this is a non-clinical device performance study, not a study involving human interpretation of medical data where expert ground truth would be required. The "ground truth" here is established by standardized testing methodologies and their respective acceptance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as this is a non-clinical device performance study. Adjudication methods are typically used in clinical studies or studies involving expert review of medical images/data.
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 information is not applicable. This is a submission for a physical medical device (surgical gown) and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a submission for a physical medical device (surgical gown) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by validated standard test methods and their predetermined acceptance criteria (e.g., AATCC42-2017, AAMI/ANSI PB70:2012, ISO 10993-5, etc.). These standards define what constitutes acceptable performance for a surgical gown.
8. The sample size for the training set:
This information is not applicable. This is a non-clinical device performance study, not a machine learning study that would have a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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(132 days)
Hubei Wanli Protective Products Co., Ltd.
The Disposable Medical Masks are 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 is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength greater than or equal to 100N; Elasticity greater than or equal to 2.8times; Breaking tension greater than 100N). The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
This 510(k) premarket notification describes the non-clinical performance evaluation of Hubei Wanli Protective Products Co., Ltd.'s "Disposable Medical Mask" (K210150) to demonstrate its substantial equivalence to the predicate device, the Kimberly-Clark KC100 Mask (K110455).
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Acceptance Criteria and Reported Device Performance:
Item Acceptance Criteria (Level 2) Reported Device Performance (Lot2020120501, Lot2020120101, Lot2020120801) Synthetic Blood Performance (ASTM F1862) 29 out of 32 pass at 120 mmHg 32 out of 32 pass at 120 mmHg Particulate Filtration Efficiency (ASTM F2299) ≥ 98% ≥ 98% Bacterial Filtration Efficiency (ASTM F2101-19, EN 14683:2019 Annex B) ≥ 98% ≥ 98% Differential Pressure (Delta P) (ASTM F2100-19, EN 14683:2019 Annex C)
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