(85 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements 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 Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.
Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.
The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
Device: Disposable Isolation Gown (K223467)
1. A table of acceptance criteria and the reported device performance:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Seam strength (sleeve seam) | To evaluate the strength of the sleeve seam | ≥30N per standard F2407-20 for level 3 | Pass |
| Tensile strength (Media Direction & Cross Direction) | To evaluate the tensile strength of the test sample | ≥30N per standard F2407-20 for level 3 | Pass |
| Tear strength (Media Direction & Cross Direction) | To evaluate the tear resistance of the test sample | ≥10N | Pass |
| Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back) | To evaluate the hydrostatic barrier property of the gown | ≥50cmH2O AQL: 4% (32 of 32 samples pass each location) | Pass |
| Lint and other particles generation in the dry state (material) | To evaluate the linting resistance of the test sample | Critical area≤4.0; Less critical area≤ 4.0 | Pass |
| Lint and other particles generation in the dry state (sleeve seam) | To evaluate the linting resistance in the dry state of the sleeve seam | Critical area≤4.0; Less critical area≤ 4.0 | Pass |
| 2-year accelerated aging (AAMI PB70:2012 - AATCC 42 Water impact & AATCC 127 Hydrostatic pressure) | To demonstrate performance stability throughout the shelf life | Meets all AAMI PB70 performance requirements; AATCC 42 ≤ 1.0 g; AATCC 127 ≥ 50 cm H2O | Pass |
| 2-year accelerated aging (ASTM F3352 - Tensile strength, Tear strength, Seam Strength, Lint generation) | To demonstrate performance stability throughout the shelf life (additional parameters) | ASTM D5034 ≥ 30 N (Machine direction and cross direction); ASTM D5733 ≥ 10 N (Machine direction and cross direction); ASTM D1683 ≥ 30 N; ISO 9037-10 Coef. of linting ≤ 4.0 | Pass |
| Flammability | To evaluate the flame resistance of the test sample | Class I | Pass |
| Water impact resistance (front, sleeve, sleeve seam, shoulder seam, back) | To evaluate the water impact barrier property of the gown | ≤1.0g AQL: 4% (32 of 32 samples pass each location); Level 3 per standard ANSI/AAMI PB70:2012 | Pass |
| Cytotoxic potential | To evaluate the cytotoxic potential of the gown | Under the conditions of the study, the device is not cytotoxic | Pass |
| Irritation | To evaluate the irritation property of the gown | Under the conditions of the study, the device is not an irritant | Pass |
| Sensitization | To evaluate the sensitization property of the gown | Under the conditions of the study, the device is not a sensitizer | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For Hydrostatic pressure test and Water impact resistance, the acceptance criteria state "32 of 32 samples pass each location." This implies a sample size of 32 for these specific tests.
- Specific sample sizes for other non-clinical tests (e.g., seam strength, tensile strength, tear strength, lint generation, flammability, biocompatibility) are not explicitly stated in this document beyond the general "sample" or "test sample." However, these types of tests typically involve testing multiple units or specimens to ensure reproducibility and statistical validity according to the referenced standards.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that the manufacturer is based in China, it is highly probable that the testing was conducted there. All tests described are non-clinical tests, which are typically conducted in a controlled laboratory setting (i.e., not on human subjects), and thus the retrospective/prospective distinction is not applicable in the same way it would be for a clinical trial.
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 the studies are entirely non-clinical (laboratory-based performance and material property testing). There are no human experts establishing a "ground truth" for diagnostic or clinical interpretation. The "ground truth" for these tests comes from adherence to established international and national standards (e.g., ASTM, ISO, AAMI, AATCC, CPSC CFR) for material properties and barrier performance.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. Since these are non-clinical, objective laboratory tests against pre-defined numerical or qualitative criteria, there is no need for expert 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, an MRMC comparative effectiveness study was not conducted. This device is a disposable isolation gown, and the submission focuses on its physical and barrier properties, not on an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not conducted. This device is manufactured personal protective equipment (PPE), not software or an AI algorithm. The performance evaluation is based on material and product testing against established engineering and safety standards.
7. The type of ground truth used:
- The "ground truth" for these non-clinical tests is based on established testing standards and regulatory requirements. This includes:
- Material properties: Tensile strength, tear strength, seam strength, lint generation, flammability, all measured against specific ASTM and ISO standards with predefined passing criteria.
- Barrier performance: Hydrostatic pressure and water impact resistance, measured against AAMI PB70:2012 (Level 3) and AATCC standards.
- Biocompatibility: Cytotoxicity, irritation, and sensitization, measured against ISO 10993 standards with "not cytotoxic," "not an irritant," and "not a sensitizer" as the ground truth.
- Shelf-life stability: Demonstrated by meeting all performance requirements after accelerated aging, with the original acceptance criteria serving as the ground truth for stability.
8. The sample size for the training set:
- This information is not applicable as the device is a physical product (disposable isolation gown), not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established:
- This information is not applicable for the reason stated above.
§ 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.