(270 days)
GCI surgical gown is 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification.
GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.
This document describes the non-clinical performance testing of the GCI Surgical Gown to demonstrate its substantial equivalence to a legally marketed predicate device (K211422).
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability | Meets Class 1 Requirements | Meets Class 1 Requirements |
| Water Resistance: Hydrostatic Pressure | Water Resistant ≥20 cm | Water Resistant ≥20 cm |
| Water Resistance: Impact Penetration | ≤1.0 g water | ≤1.0 g water |
| Breaking / Bursting Strength | ≥20 N | >20 N |
| Tearing Strength | ≥20 N | >20 N |
| Seam Strength | ≥20 N | >20 N |
| Linting | Log10 |
§ 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.