(183 days)
UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.
The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.
The provided text describes a 510(k) submission for a surgical gown and therefore does not include information relevant to a medical device that utilizes AI/ML or requires a study with a test set, ground truth establish by experts, or training set as described in the prompt. The "device" in this context is a physical product (a surgical gown), not a software algorithm.
Therefore, most of the requested fields are not applicable.
Here's an analysis of the provided text based on the categories you've requested, highlighting why many are not present:
Acceptance Criteria and Device Performance for UltraGard™ Blue Operating Room Gown
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| ASTM F1670-98 (Resistance to Penetration by Synthetic Blood) | Pass (in the reinforced gown areas) |
| ASTM F1671-97b (Viral Penetration) | Pass (in the reinforced gown areas) |
| National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability" | Meets Class 1 |
| ISO 10993 (Biocompatibility for surface devices, intact skin, limited duration ( |
§ 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.