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510(k) Data Aggregation
(261 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 requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI 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. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014.
The Surgical Gown is composed of collar, body, sleeve and tie, in a blue color, offered in sizes S, M, L, XL and XXL. The neck and waist are laced, the sleeves are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Surgical Gown (K222999)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 42 | Impact Penetration | Level 3, ≤1.0g | <1.0g |
| AATCC 127 | Hydrostatic Resistance | Level 3, ≥50cm | ≥50cm |
| ASTM D5034 | Tensile strength | Machine direction mean: ≥18 lbf; Cross direction mean: ≥12 lbf | Machine direction mean ≥32.9 lbf; Cross direction mean ≥26.3 lbf |
| ASTM D5587 | Tear resistance | Fabric direction A mean: ≥4.0 lbf; Fabric direction B mean: ≥2.5 lbf | Machine direction mean ≥9.3 lbf; Cross direction mean ≥18.2 lbf |
| ASTM D1683 | Seam strength | Shoulder: ≥8.5 lbf; Arm opening: ≥5.5 lbf; Sleeve: ≥8.5 lbf | Shoulder: ≥10.1 lbf; Arm opening: ≥7.2 lbf; Sleeve: ≥10.1 lbf |
| ASTM F1868 | Evaporative Resistance of fabrics | Mean Evaporative Resistance (Ref) ≥0.06 (kPa·m²/W) | Mean Evaporative Resistance (Ref) ≥0.06 (kPa·m²/W) |
| ISO 9073-10 | Lint and Other particles generation in the dry state | Log10 < 4 | Index for Particulate Matter (IPM) < 2.89 |
| 16 CFR Part 1610 | Flammability testing | Class 1, Non Flammable | Class 1, Non Flammable |
| Cytotoxicity | Biocompatibility - cytotoxicity | No potential cytotoxicity | No potential cytotoxicity |
| Irritation | Biocompatibility - irritation | No irritation | No irritation |
| Sensitization | Biocompatibility - sensitization | No sensitization | No sensitization |
| Acute systemic toxicity | Biocompatibility - Acute systemic toxicity | No acute systemic toxicity in vivo | No acute systemic toxicity in vivo |
| Ethylene oxide residues | Ethylene oxide sterilization residuals | EO ≤ 4mg/device; ECH ≤ 9mg/device | EO: 3.68 mg/device; ECH: 0.94 mg/device |
The reported device performance for all criteria met or exceeded the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gowns were tested for impact penetration). It only states that the device "was tested and conformed to the related recognized standards." The provenance of the data is implied to be from testing conducted by or for Hubei Woozon Healthcare Co.,Ltd. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating that they were non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a surgical gown, and its performance is evaluated through standardized physical, chemical, and biological barrier tests, not through expert human interpretation of medical images or data requiring ground truth establishment by medical experts.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation relies on adherence to standardized test methods and their defined pass/fail criteria, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This type of study is not relevant for the evaluation of a surgical gown. MRMC studies are typically conducted for AI/CAD systems that assist human readers in interpreting medical images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The "device" in this context is a physical product (surgical gown), not an algorithm or AI system. Its performance is inherent to the product itself, not an algorithmic output.
7. The Type of Ground Truth Used:
The "ground truth" for the surgical gown is established by the specified performance requirements and limitations outlined in the recognized standards (e.g., AAMI PB70, AATCC, ASTM, ISO, 16 CFR). These standards define the acceptable levels of barrier protection, strength, flammability, and biocompatibility. The results of the tests conducted directly against these standards serve as the evidence that the device meets the "ground truth" requirements.
8. The Sample Size for the Training Set:
Not applicable. This device is a manufactured product, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
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