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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

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