(88 days)
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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization to ISO 11135-1.
The proposed devices are 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 devices are single use, disposable medical devices and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.
The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.
The provided text describes the non-clinical testing of surgical gowns to demonstrate their substantial equivalence to predicate devices, rather than a study for an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, performance, ground truth, experts, and training/test set details cannot be extracted from this document.
However, I can provide the acceptance criteria and performance results for the physical properties and biocompatibility of the surgical gowns based on the provided tables.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability | Meets Class 1 requirements | Class 1 |
| Hydrostatic pressure | Level 2 Surgical Gown: >20 cm H2O; Level 3 Surgical Gown: >50 cm H2O; Level 4 Surgical Gown: >50 cm H2O | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 40.57cm; (Sterile): Average 40.21cm (Meets Level 2) |
| 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 83.53cm; (Sterile): Average 83.57cm (Meets Level 3) | ||
| 43g Standard SMMS Surgical Gown: (Non-sterile): Average 60.50 cm; (Sterile): Average 60.48 cm (Meets Level 3) | ||
| 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 99.59 cm; (Sterile): Average 98.90 cm (Meets Level 3) | ||
| 50g Standard SMMS Surgical Gown: (Non-sterile): Average 83.19 cm; (Sterile): Average 83.02 cm (Meets Level 3) | ||
| 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 108.37 cm; (Sterile): Average 108.37 cm (Meets Level 3) | ||
| BVB Surgical Gown: (Non-sterile): Average 161.71 cm; (Sterile): Average 162.11 cm (Meets Level 4) | ||
| Water impact | ≤1.0 g | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 0.041g; (Sterile): Average 0.03g |
| 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.03g; (Sterile): Average 0.029g | ||
| 43g Standard SMMS Surgical Gown: (Non-sterile): Average 0.036g; (Sterile): Average 0.033g | ||
| 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.032g; (Sterile): Average 0.032g | ||
| 50g Standard SMMS Surgical Gown: (Non-sterile): Average 0.031g; (Sterile): Average 0.034g | ||
| 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.033g; (Sterile): Average 0.031g | ||
| BVB Surgical Gown: (Non-sterile): Average 0.078g; (Sterile): Average 0.079g (All meet criteria) | ||
| Breaking strength | ≥30N | 35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 108.37N; Longitude: 161.87N; (Sterile): Latitude: 108.37N; Longitude: 161.87N |
| 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 108.72N; Longitude: 161.19N; (Sterile): Latitude: 108.53N; Longitude: 161.31N | ||
| 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 113.34N; Longitude: 182.30N; (Sterile): Latitude: 113.01N; Longitude: 181.05N | ||
| 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 113.72N; Longitude: 181.14N; (Sterile): Latitude: 112.60N; Longitude: 181.26N | ||
| 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 137.58N; Longitude: 190.87N; (Sterile): Latitude: 137.77N; Longitude: 188.30N | ||
| 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 138.02N; Longitude: 191.32N; (Sterile): Latitude: 138.39N; Longitude: 190.07N | ||
| BVB Surgical Gown: (Non-sterile): Latitude: 148.44N; Longitude: 236.60N; (Sterile): Latitude: 148.93N; Longitude: 237.72N (All values significantly greater than 30N) | ||
| Tearing strength | ≥10N | 35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 32.49N; Longitude: 39.67N; (Sterile): Latitude: 32.31N; Longitude: 39.81N |
| 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 32.44N; Longitude: 39.67N; (Sterile): Latitude: 32.55N; Longitude: 39.92N | ||
| 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 33.99N; Longitude: 41.40N; (Sterile): Latitude: 33.92N; Longitude: 41.75N | ||
| 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 34.09N; Longitude: 41.51N; (Sterile): Latitude: 34.01N; Longitude: 41.18N | ||
| 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 44.02N; Longitude: 54.18N; (Sterile): Latitude: 44.36N; Longitude: 54.07N | ||
| 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 43.93N; Longitude: 53.96N; (Sterile): Latitude: 44.30N; Longitude: 54.25N | ||
| BVB Surgical Gown: (Non-sterile): Latitude: 49.76N; Longitude: 53.97N; (Sterile): Latitude: 49.23N; Longitude: 53.98N (All values significantly greater than 10N) | ||
| Linting | Log10(particle count) |
§ 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.