(268 days)
The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| ANSI/AAMI PB70:2012 (Overall classification) | Meets Level 3 and Level 4 Liquid Barrier Requirements | Meets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirements | Pass |
| Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm) | $\ge$ 50 cm | All samples passed at $\ge$ 50 cm | Pass |
| Flammability of Clothing Textiles - 16 CFR Part 1610 (a) | Class 1: $\ge$ 3.5 seconds | All samples passed at $\ge$ 3.5 seconds | Pass |
| Durability ASTM D-5034 | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Tensile Strength ASTM D-5034 Machine Direction and Cross Direction | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Trap Tear ASTM D5587-15 Machine Direction and Cross Direction | $\ge$ 2.3 lbf | All samples passed at $\ge$ 2.3 lbf | Pass |
| Water Resistance Impact Penetration Test AATCC 42 | $\le$ 1.0 g | All samples passed at $\le$ 1.0 g | Pass |
| ASTM D1683 Seam Strength | $\ge$ 7 lbf | All samples passed at $\ge$ 7 lbf | Pass |
| ASTM F1671 Viral Penetration | Level 4: No penetration at 2 psi | All samples showed no penetration at 2 psi | Pass |
| Ethylene oxide residuals ISO 10993-7 | EO |
§ 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.