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510(k) Data Aggregation
(209 days)
High protection surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 classification.
The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
The medical device in question is a High Protection Surgical Gown (product code FYA, regulation number 21 CFR 878.4040, Class II).
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability (16 CFR Part 1610) | Evaluate flammability of the test sample. | Meets requirements | Class 1 |
| Hydrostatic Pressure (AATCC 127) | Determine hydrostatic pressure of the test sample. | ≥50 cm H2O | 204.6 cm H2O |
| Water Impact (AATCC 127) | Determine hydrostatic pressure of the test sample (likely a typo, AATCC 42 is typically for impact penetration). | ≤1.0 g | 0.02g |
| Breaking Strength (ASTM D 5034) | Evaluate breaking strength of the test sample. | ≥30 N | Longitude: 131.5N, Latitude: 75.2N |
| Tearing Strength (ASTM D5587) | Evaluate tearing strength of the test sample. | ≥10 N | Longitude: 79.0N, Latitude: 33.8N |
| Linting (ISO 9073-10) | Evaluate linting of the test sample. | Log10(particle count) |
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(240 days)
This mask is intended to be worn to protect both the patient and healthcare worker of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use device provided non-sterile
These 3 Layer Surgical Masks: Level 1, Level 2 or Level 3 (with Ear Loops or Ties) are 3 layer, flat-folded masks constructed of 100% nonwoven polypropylene materials. The masks are provided with Ear Loops (Polyester/Spandex) or Ties (Polypropylene). A malleable nose strip is placed within the binding for comfort and individualized fit. These masks meet the acceptance criteria for ASTM F 2100, Level 1, Level 2 or Level 3 performance standards and are provided in blue. These masks are single use and provided non-sterile.
This document is a 510(k) Premarket Notification for 3A Medical Products Co., Ltd.'s 3 Layer Surgical Masks, seeking substantial equivalence to a predicate device. It details the masks' performance characteristics against recognized consensus standards for surgical masks.
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A table of acceptance criteria and the reported device performance:
Test Methods Acceptance Criteria for Proposed Device Levels Reported Device Performance (Proposed Device) Predicate Device Performance Comparison ASTM F2100 (Performance Standard) N/A (Categorizes into levels 1, 2, 3) Level 1, Level 2, Level 3 Level 1, Level 2, Level 3 Same ASTM F1862 (Fluid Resistance) Pass at 80 mmHg (Level 1) Pass at 80 mmHg Pass at 80 mmHg Same Pass at 120 mmHg (Level 2) Pass at 120 mmHg Pass at 120 mmHg Same Pass at 160 mmHg (Level 3) Pass at 160 mmHg Pass at 160 mmHg Same ASTM F2299 (Particulate Filtration Efficiency) N/A (Measured for comparison against predicate) Pass at 98.86% (Level 1) Pass at 99.6% Similar Pass at 98.8% (Level 2) Pass at 99.6% Similar Pass at 98.6% (Level 3) Pass at 99.7% Similar ASTM F2101 (Bacteria Filtration Efficiency) N/A (Measured for comparison against predicate) Pass at 99.9% (Level 1) Pass at >98% Similar Pass at 99.9% (Level 2) Pass at >98% Similar Pass at 99.9% (Level 3) Pass at >99% Similar EN14683 (Proposed) / MIL-M36945C (Predicate) (Differential Pressure) N/A (Measured for comparison against predicate) Pass at 4.1 mm H2O/cm² (Level 1) Pass at 2.0mm H2O/cm² Similar Pass at 4.0 mm H2O/cm² (Level 2) Pass at 1.6mm H2O/cm² Similar Pass at 4.53 mm H2O/cm² (Level 3) Pass at 2.5mm H2O/cm² Similar 16 CFR 1610 (Flammability) Class 1 Class 1 (all levels) Class 1 Same ISO 10993-5:2010 (Cytotoxicity) Non-toxic potential to L929 cells No potential toxicity to L929 cells (all levels) Non-cytotoxic Similar ISO 10993-10:2010 (Irritation) No potential skin irritation on rabbits No potential skin irritation on rabbits (all levels) Non-irritating Similar ISO 10993-10:2010 (Sensitization) No potential skin sensitization on guinea pigs No potential skin sensitization on guinea pigs (all levels) Non-sensitizing Similar -
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 explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The data provenance is derived from tests conducted to demonstrate conformance to recognized consensus standards like ASTM and ISO. The manufacturer, 3A Medical Products Co., Ltd., is located in Liu An, Anhui Province, People's Republic of China, suggesting the testing was likely conducted in or for China on a prospective basis for market clearance. -
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 testing against performance standards for medical devices, not an algorithm that requires expert ground truth establishment. The "ground truth" here is defined by the objective, quantifiable metrics set forth in recognized international standards (e.g., ASTM, ISO). Therefore, no human experts for establishing ground truth are applicable in this context. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used for subjective interpretations or diagnostic accuracy studies, not for objective physical and biological performance testing of a medical device like a surgical mask against established standards. -
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. This is a submission for a physical medical device (surgical masks), not an AI-powered diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance of these surgical masks is established by the objective, quantitative results of standardized laboratory tests against recognized consensus standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific methodologies and thresholds that a device must meet to achieve a certain performance level. -
The sample size for the training set:
Not applicable. This document relates to a physical medical device and its performance testing, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical medical device.
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