(517 days)
The Bodygard SFS Surgical Gown Level 3 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, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL).
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
The provided document is limited to a 510(k) summary for a surgical gown (Bodygard SFS Surgical Gown Level 3). It details non-clinical performance and substantial equivalence to a predicate device, but it does not contain information on clinical studies, AI algorithms, or human reader performance. Therefore, I cannot answer questions related to those topics.
Here's a breakdown of what can be extracted from the document regarding acceptance criteria and non-clinical studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AATCC 127 (Water resistance Hydrostatic Pressure) | >50cmH2O (AQL 4%, RQL=20%) | All were > 50cmH2O |
| AATCC 42 (Water Resistance impact penetration) | 30 N (AQL 4%, RQL=20%) | All were >30N |
| ASTM D5587-14 (Tearing Strength) | >20 N (AQL 4%, RQL=20%) | All were >20 N |
| 16 CFR 1610 (Flammability testing) | Class I | Meets Class I |
| ASTM D4169-16 (Seam Strength) | >50 N (AQL 4%, RQL=20%) | All were >50 N |
| D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers) | >500 gram/m2 Day WVTR | Passed |
| ASTM D3776/D (Mass Per Area (Weight) of fabric) | - | Has met acceptance criteria |
| ASTM F1670 (Resistance by synthetic Blood) | No Penetration at 2 psi (13.8 kPA) | Passed |
| ISO 9073-10:2003 (Lint and Other particles generation in the dry state) | Log 10 |
§ 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.