(163 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.