(567 days)
The Disposable Surgical Gown Rk-3011C is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the 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 Disposable Surgical Gown Rk-3011C surgical gowns met the requirements for Level 3 classification.
This is a single use, disposable device(s), provided non-sterile. The Surgical Gowns is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
The proposed surgical gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relablers for further packaging and Ethylene Oxide (EO) sterilization.
The gown is manufactured with four layers: the inner and outer layers are made of spun-bond polypropylene and the middle layers are made of melt blown polypropylene. All gowns are reinforced with polypropylene and microporous reinforcement material. The proposed surgical gown is only available in the available sizes of the proposed surgical gown are M, L, XL, and XXL.
The cuffs are composed of cotton and terylene. The back is open with ties to secure the gown.
The provided text describes the acceptance criteria and the study results for a medical device, specifically a "Disposable Surgical Gown Rk-3011C".
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|
| Tensile Testing: ≥30N | Head To Toe Peak Load (N) AVG: 138.8N, Cross Body AVG: 95.6N | Pass |
| Tearing Strength of Fabrics: ≥10N | HEAD TO TOE AVG: 57.3N, CROSS BODY AVG: 37.5N | Pass |
| Seam Strength: ≥30N | Min 59.0N | Pass |
| Water Resistance (Spray Impact Water): 50cmH2O) | Pass | |
| Determining Lint: |
§ 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.