BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN

Q: Who is the manufacturer of BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN?

Bemiss-Jason Corp., Triad Medical Div. filed the 510(k) submission for BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN (K962666).

Q: What is the FDA product code for BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN?

FYA. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN?

Isolyser (Mars White Knight) surgical gowns.

Q: Who can help prepare an FDA 510(k) submission like BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K962666 · Bemiss-Jason Corp., Triad Medical Div. · FYA · Feb 27, 1997 · General, Plastic Surgery

Device Facts

Record ID	K962666
Device Name	BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
Applicant	Bemiss-Jason Corp., Triad Medical Div.
Product Code	FYA · General, Plastic Surgery
Decision Date	Feb 27, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel.

Device Story

Disposable surgical gowns (reinforced and non-reinforced) designed for use by operating room personnel. Gowns function as protective apparel to prevent fluid transfer between patient and staff. Manufactured using Sontara®, Dexter®, or Securon® materials; materials selected for fluid/alcohol repellency. Used in surgical settings; worn by surgeons, nurses, and OR staff. Provides barrier protection to reduce cross-contamination risk during procedures.

Clinical Evidence

Bench testing only. Evaluations included physical properties analysis, colorfastness, cytotoxicity, skin irritation/sensitization, and flammability (Class I). ETO residual testing performed and confirmed to be below 1978 FDA proposed guidelines.

Technological Characteristics

Materials: S/M/S trilaminate polypropylene (spunbond outer/meltblown inner). Styles: Reinforced and non-reinforced. Sizes: Large and X-Large. Flammability: Class I. Sterilization: ETO (for sterile versions).

Indications for Use

Indicated for operating room personnel during surgical procedures to provide protection to both the patient and the personnel.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Isolyser (Mars White Knight) surgical gowns

Related Devices

K080627 — PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A · Promedical Products Co., Ltd. · Apr 24, 2008
K070431 — WELMED, INC. SURGICAL GOWNS · Welmed, Inc. · May 24, 2007
K141467 — SURGICAL GOWN · Xuchang Zhengde Environstar Medical Products Co.,L · Mar 5, 2015
K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown · Cardinal Health200, LLC · Jul 29, 2020
K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE · Deroyal · Nov 20, 2003

Submission Summary (Full Text)

{0} From: Ron Arkin FDA & ISO Consulting Fax: 770-565-9762 FEB 27 1997 K962666 SMDA-1990 510(k) Summary -- K962666 In response to the requirements addressed by the SMDA of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. Substantial equivalence for the Bemiss Jason Surgical Gowns (reinforced and non-reinforced) is claimed due to material similarities, intended uses and safety/effectiveness. A. Submitted by: Bemiss Jason / Triad Medical Division 405 Walnut Street PO Box 1436 Waynesville, NC 28786 Phone: 704-452-1919 Fax: 704-452-3702 B. Contact: Sandra L. McGee Quality Assurance/Compliance Officer C. Submission Date: July 03, 1996 D. Common or Usual Names: Sterile Surgical gown Non - Sterile Surgical gown E. Trade or Proprietary Names: Bemiss Jason Sterile Surgical Gown - Sontara® Bemiss Jason Sterile Surgical Gown - Dexter® Bemiss Jason Sterile Surgical Gown - Securon® Bemiss Jason Non-Sterile Surgical Gown - Sontara® Bemiss Jason Non-Sterile Surgical Gown - Dexter® Bemiss Jason Non-Sterile Surgical Gown - Securon® Bemiss Jason Reinforced Sterile Surgical Gown - Sontara® Bemiss Jason Reinforced Sterile Surgical Gown - Dexter® Bemiss Jason Reinforced Sterile Surgical Gown - Securon® Bemiss Jason Reinforced Non-Sterile Surgical Gown - Sontara® Bemiss Jason Reinforced Non-Sterile Surgical Gown - Dexter® Bemiss Jason Reinforced Non-Sterile Surgical Gown - Securon® All Surgical Gowns would be available in Large and X-Large {1} From: Ron Arkin FDA & ISO Consulting Fax: 770-565-9762 SMDA-1990 -- 510(k) Summary (Continued) K962666 Page 2 F. Intended Use Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel. G. Summary The substantial equivalence (SE) is primarily based upon surgical gowns presently manufactured by Isolyser (Mars White Knight) composed of an S/M/S trilaminate polypropylene spunbond outers / meltblown (polypropylene) inner layer. This fabric has shown fluid and alcohol repellency. Other referenced materials have also been shown to be fluid and alcohol repellent. Physical properties comparisons have shown that not only is one of the materials identical, the other materials have similar properties. All fabrics identified have previously been on the market. Intended uses for these materials by Bemiss Jason is consistent with current (existing) usage for surgical gowns. Safety and effectiveness evaluation of the fabric combinations have been performed by the material manufacturers and Bemiss Jason. These evaluations have shown the materials to be colorfast and non cytotoxic. Preliminary ETO residual testing has shown to be well below the 1978 FDA proposed ETO residual guidelines. Some manufactures have shown their materials to be free of skin irritation and sensitization. Flammability classification has been determined as Class I. In summary, the materials referenced in this SE submission for 510(k) is not new, nor is it for a new intended use. The materials have been widely available and used as surgical gowns. Manufacturers are currently shaping this material into gowns in both reinforced and non-reinforced styles. Physical, aesthetic, tactile and functional qualities of the material selected for the Bemiss Jason Surgical Gowns have been analyzed and evaluated. The materials are safe for both providers and patients and effective in function when used with standard normal intended use.