(175 days)
The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).
The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 requirement.
The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria (Requirement) | Reported Device Performance (Average, 32 samples/lot) |
|---|---|---|
| Flammability (16 CFR Part 1610-2008) | Class I | Lot1: Class I, Lot2: Class I, Lot3: Class I |
| Hydrostatic Pressure (AATCC 127) | Level 3: >50 cmH2O | Lot1: Front: 151.6, Back: 142.8, Sleeve: 148.5, Sleeve seam: 149.8, Shoulder seam: 155.3, Waistband seam: 99.5 |
| Lot2: Front: 165.4, Back: 158.4, Sleeve: 153.4, Sleeve seam: 133.5, Shoulder seam: 141.2, Waistband seam: 59.1 | ||
| Lot3: Front: 163.7, Back: 154.4, Sleeve: 153.9, Sleeve seam: 130.7, Shoulder seam: 143.2, Waistband seam: 58.3 | ||
| Impact Penetration (AATCC 42) | Level 3: 1.00 kPa·m²/W | Lot1: >1.0 kPa·m²/W, Lot2: >1.0 kPa·m²/W, Lot3: >1.0 kPa·m²/W |
| Cytotoxicity (EN ISO10993-5) | Non-Cytotoxic | PASS (non-Cytotoxic) |
| Irritation (EN ISO 10993-10) | Non-Irritating | PASS (non-Irritating) |
| Sensitization (EN ISO 10993-10) | Non-Sensitizing | PASS (non-Sensitizing) |
2. Sample size used for the test set and the data provenance
The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).
4. Adjudication method for the test set
Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.
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
Not applicable. This document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:
- Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
- Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).
8. The sample size for the training set
Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm 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.
§ 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.