RoyalGuard Surgical Gown, i600, Breathable
Device Facts
| Record ID | K172445 |
|---|---|
| Device Name | RoyalGuard Surgical Gown, i600, Breathable |
| Applicant | Gri Medical & Electrical Technology Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Dec 8, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The RoyalGuard Surgical Gown, i600, Breathable has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Device Story
Single-use surgical gown; protects patients and OR personnel from microorganisms, body fluids, and particulates. Constructed of tri-laminate Breathable Viral Barrier (BVB) fabric (spunbond polyolefin outer/inner layers, monolithic film middle layer) in front body and sleeves; sleeves include additional film reinforcement bi-laminate. Back panels consist of single-layer SMS polyolefin nonwoven. Features neck binder, hook and loop tabs, belt ties, and optional thumb-hooks. Available in various sizes, including A-frame designs for sitting procedures. Used in healthcare facilities; worn by surgical staff. Provides AAMI Level 4 liquid barrier protection in critical zones. Biocompatible and anti-static. Sterilized via Ethylene Oxide.
Clinical Evidence
Bench testing only. Device tested per AAMI PB70:2012 for liquid barrier performance (Level 4 in critical zones, Level 1 in non-critical zones). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation). Physical properties tested per ASTM standards (D3776, D5034, D5587, D1683, E96). Flammability tested per 16 CFR Part 1610 (Class 1).
Technological Characteristics
Tri-laminate BVB fabric (spunbond polyolefin/monolithic film/spunbond polyolefin) in front/sleeves; film-reinforced bi-laminate in sleeve critical zones; SMS polyolefin nonwoven in back. Anti-static treatment. Sterilization: Ethylene Oxide. AAMI PB70 Level 4 barrier performance. Complies with ASTM D3776, D5034, D5587, D1683, E96, and 16 CFR 1610.
Indications for Use
Indicated for use as a single-use surgical gown to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Classified as AAMI Level 4 in critical zones.
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
- GRI ComfortGuard Surgical Gown, i600, Film Reinforced (K163191)
Reference Devices
- Halyard Aero Chrome Breathable Performance Surgical Gown (K153255)
Submission Summary (Full Text)
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December 8, 2017
GRI Medical & electrical Technology Co., Ltd % Harry Shaffer President Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, Colorado 80129
Re: K172445
Trade/Device Name: RoyalGuard Surgical Gown, i600, Breathable Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 3, 2017 Received: November 7, 2017
Dear Harry Shaffer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Tara A. Ryan -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K172445
Device Name RoyalGuard Surgical Gown, i600, Breathable
### Indications for Use (Describe)
The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The RoyalGuard Surgical Gown, i600, Breathable has been tested as Level 4 in the critical zones per A AMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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Confidential
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## SECTION C Summary
### 1 510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) number: | K172445 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | Nov 3rd, 2017 |
| Applicant: | GRI Medical & Electronic Technology Co., Ltd. |
| Contact: | Martin Paugh, V.P. of RA/QA<br>1805 HongGao Road<br>XiuZhou Industry Zone<br>JiaXing, ZheJiang, China, 314031<br>Tel: 86-135-1135-9722<br>Email: mpaugh@gri-china.com |
| Official Correspondent: | Harry Shaffer, President<br>Sterilization Consulting Services LLC<br>10051 Oak Leaf way, Highlands Ranch, CO 80129<br>Tel: 303-929-3808<br>Email: HShaffer@Sterilizationconsulting.com |
| Device Trade Name: | RoyalGuard Surgical Gown, i600, Breathable |
| Common or Usual Name: | Surgical gown |
| Classification Name: | Surgical Apparel |
| Device Classification: | Class II per 21 CFR §878.4040<br>General and plastic surgery<br>Product Code: FYA |
| Predicate Device:<br>Reference Device | GRI ComfortGuard Surgical Gown, i600, Film Reinforced (K163191)<br>Halyard Aero Chrome Breathable Performance Surgical Gown<br>(K153255) |
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Image /page/4/Picture/0 description: The image contains the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized, lowercase font, with a curved blue line above the "i". Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font. The overall design is simple and modern, with a focus on the company's initials.
#### Description of the Device 1.1
The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) consists of a tri-laminate fabric Breathable Viral Barrier (BVB) including an outer and inner layer of spunbond polyolefin fabric with a middle layer of breathable monolithic film in the gown front body and gown sleeves. The gown sleeves critical zones also consist of an additional layer of Film Reinforcement Bi-laminate material, including a layer of spunbond and a layer of film. The gown back panels are comprised of a single layer of SMS (polyolefin nonwoven).
The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, A-frame L-XLONG, Aframe XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures.
The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-51) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs. The addition of thumb-hooks does not impact the performance of the gown in accordance with AAMI PB70 requirement.
#### 1.2 Indications for Use
The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The RoyalGuard Surgical Gown, i600, Breathable has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
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### Product Codes covered in this submission 1.3
Table 1 Product List
| Product List | | |
|--------------------------------------------|-----------------------------------|--------------------------------|
| Product Name | Model Code without<br>Thumb-hooks | Model Code with<br>Thumb-hooks |
| RoyalGuard Surgical Gown, i600, Breathable | i90-61xx-S1 | i90-61xxT-S1 |
| | i90-61xx | i90-61xxT |
Table 2 Product Catalog Number and Description
| Catalog # | | | | | |
|-----------------------|--------------------|-----------------------|--------------------|--------------------------------------------|-------------------|
| Sterile | | Non-Sterile | | | |
| Without<br>Thumb-hook | With<br>Thumb-hook | Without<br>Thumb-hook | With<br>Thumb-hook | Model Description | Size |
| i90-6100-S1 | i90-6100T-S1 | i90-6100 | i90-6100T | RoyalGuard Surgical Gown, i600, Breathable | S |
| i90-6110-S1 | i90-6110T-S1 | i90-6110 | i90-6110T | RoyalGuard Surgical Gown, i600, Breathable | M |
| i90-6120-S1 | i90-6120T-S1 | i90-6120 | i90-6120T | RoyalGuard Surgical Gown, i600, Breathable | L |
| i90-6130-S1 | i90-6130T-S1 | i90-6130 | i90-6130T | RoyalGuard Surgical Gown, i600, Breathable | XL |
| i90-6140-S1 | i90-6140T-S1 | i90-6140 | i90-6140T | RoyalGuard Surgical Gown, i600, Breathable | XXL |
| i90-6122-S1 | i90-6122T-S1 | i90-6122 | i90-6122T | RoyalGuard Surgical Gown, i600, Breathable | L, XLONG |
| i90-6132-S1 | i90-6132T-S1 | i90-6132 | i90-6132T | RoyalGuard Surgical Gown, i600, Breathable | XL, XLONG |
| i90-6142-S1 | i90-6142T-S1 | i90-6142 | i90-6142T | RoyalGuard Surgical Gown, i600, Breathable | XXL, XLONG |
| i90-6124-S1 | i90-6124T-S1 | i90-6124 | i90-6124T | RoyalGuard Surgical Gown, i600, Breathable | A-frame, L, XLONG |
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Image /page/6/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized, bold, black font, with a blue curved line above the "i". Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font. The logo is simple and professional, conveying a sense of global reach and expertise.
#### 1.1 Summary of technological characteristics compared to the predicate
A comparison table for the proposed device, predicate device and reference device is provided in below table.
### Table C 4 Comparison of Proposed Device, Predicate Device and Reference Device
### General Information
| Element of<br>Comparison | Device<br>Description | Subject Device<br>GRI RoyalGuard Surgical Gown,<br>i600, Breathable (i90-61xx-S1) | Predicate Device<br>GRI ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1)<br>K163191 | Reference Device<br>Halyard Aero Chrome Breathable<br>Performance Surgical Gown<br>(4467x)<br>K153255 | |
|------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Manufacturer | GRI | GRI | Halyard | |
| | Product<br>Trade Name | RoyalGuard Surgical Gown, i600,<br>Breathable | ComfortGuard Surgical Gown, i600,<br>Film Reinforced | Aero Chrome Breathable<br>Performance Surgical Gown | |
| | Classification<br># | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | |
| | Classification<br>Name | Surgical Apparel | Surgical Apparel | Surgical Apparel | |
| | Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | |
| | AAMI PB 70<br>Classification | Level 4 | Level 4 | Level 4 | |
| | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| | Comparison | Subject device is substantially<br>equivalent to the predicate in<br>classification and sterilization<br>method. | Predicate Device- This device is a<br>level 4 Film-Reinforced surgical<br>gown per K163191 submission, and<br>is used as the predicate. | Reference Device – this device is a<br>level 4 surgical gown per K153255<br>submission, and is used as the<br>reference device for "breathable"<br>claim reference. | |
| | Indications for Use | | | | |
| Element of<br>Comparison | Device<br>Description | Subject Device<br>GRI RoyalGuard Surgical Gown,<br>i600, Breathable (i90-61xx-S1) | Predicate Device<br>GRI ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1)<br>K163191 | Reference Device<br>Halyard Aero Chrome Breathable<br>Performance Surgical Gown (4467x)<br>K153255 | |
| Indications for Use | Indications<br>for Use | The RoyalGuard Surgical Gown, i600,<br>Breathable is a single use surgical<br>gown intended to protect surgical<br>patients and operating room<br>personnel from the transfer of<br>microorganisms, body fluids, and<br>particulate material.<br>The RoyalGuard Surgical Gown, i600,<br>Breathable has been tested and is<br>classified as Level 4 in the critical<br>zones per AAMI Standard PB70<br>Liquid barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>healthcare facilities. | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced is a single use<br>surgical gown intended to protect<br>surgical patients and operating<br>room personnel from the transfer of<br>microorganisms, body fluids, and<br>particulate material.<br>The ComfortGuard Surgical Gown,<br>i600, Film Reinforced has been<br>tested and is classified as Level 4 in<br>the critical zones per AAMI Standard<br>PB70 Liquid barrier performance<br>and classification of protective<br>apparel and drapes intended for use<br>in healthcare facilities. | The Aero Chrome* Breathable<br>Performance Surgical Gowns are<br>sterile, single use surgical apparel<br>intended to be worn by healthcare<br>professionals to help protect both<br>the patient and the healthcare<br>worker from the transfer of<br>microorganisms, body fluids, and<br>particulate matter.<br>The Aero Chrome* Breathable<br>Performance Surgical Gowns meet<br>the Level 4 requirements of the<br>AAMI PB70:2012 Liquid Barrier<br>classifications.<br>The Aero Chrome* Breathable<br>Performance Surgical Gowns are<br>also sold as bulk non-sterile, single<br>use items, to repackager/relabeler<br>establishments for further packaging<br>and Ethylene Oxide (EtO)<br>sterilization. | |
| | Comparison | Subject device is substantially<br>equivalent to the predicate in its<br>indications for use. The subject<br>device and predicate are Level 4 | Predicate Device- This device is a<br>level 4 Film-Reinforced surgical<br>gown per K163191 submission, and<br>is used as the predicate. | Reference Device - this device is a<br>level 4 surgical gown per K153255<br>submission, and is used as the<br>reference device for "breathable"<br>claim reference. | |
| Element of<br>Comparison | Device<br>Description | Subject Device<br>GRI RoyalGuard Surgical Gown, i600,<br>Breathable (i90-61xx-S1) | Predicate Device<br>GRI ComfortGuard Surgical Gown, i600, Film<br>Reinforced (i90-82xx-S1)<br>K163191 | Reference Device<br>Halyard Aero Chrome<br>Breathable Performance<br>Surgical Gown (4467x)<br>K153255 | |
| Technological Characteristics | Device Description | The RoyalGuard Surgical Gown, i600, Breathable<br>(i90-61xx-S1) consists of a tri-laminate fabric<br>Breathable Viral Barrier (BVB) including an outer<br>and inner layer of spunbond polyolefin fabric<br>with a middle layer of breathable monolithic film<br>in the gown front body and gown sleeves. The<br>gown sleeves critical zones also consist of an<br>additional layer of Film Reinforcement Bi-<br>laminate material, including a layer of spunbond<br>and a layer of film. The gown back panels are<br>comprised of a single layer of SMS (polyolefin<br>nonwoven).<br>The RoyalGuard Surgical Gown, i600, Breathable<br>(i90-61xx-S1) is provided with neck binder, hook<br>and loop tabs, belt ties, removable transfer<br>accessory, and cuffs.<br>The RoyalGuard Surgical Gown, i600, Breathable<br>(i90-61xx-S1) has been tested according to AAMI<br>PB70:2012 and met the AAMI Level 4 liquid<br>barrier performance requirements. It is<br>constructed with or without thumb-hooks in<br>cuffs. The addition of thumb-hooks does not<br>impact the performance of the gown in<br>accordance with AAMI PB70 requirement. | The ComfortGuard Surgical Gown, i600, Film<br>Reinforced (i90-82xx-S1) consists of a multi-layer<br>in the critical zones (SMS & Film Lamination),<br>single layer of SMS (polyolefin nonwoven) in the<br>non-critical zones in the body and sleeve, single<br>layer of SMS (polyolefin nonwoven) in the back<br>panel with a lower basis weight SMS.<br>The ComfortGuard Surgical Gown, i600, Film<br>Reinforced (i90-82xx-S1) is provided with neck<br>binder, hook and loop tabs, belt ties, removable<br>transfer accessory, and cuffs.<br>The ComfortGuard Surgical Gown, i600, Film<br>Reinforced (i90-82xx-S1) has been tested<br>according to AAMI PB70:2012 and met the AAMI<br>Level 4 liquid barrier performance requirements.<br>It is constructed with or without thumb-hooks in<br>cuffs, with pleats in the back panels, with a lower<br>basis weight SMS in the back panel. The addition<br>of thumb-hooks, back pleats, and the use of a<br>lighter basis weight material in the back panels<br>does not impact the performance of the gown in<br>accordance with AAMI PB70 requirement. | The Aero Chrome* Breathable<br>Performance Surgical Gowns have a<br>Spunbond/ Film/ Spunbond/<br>Meltblown/ Spunbond design<br>(SFSMS) that provides AAMI Level 4<br>liquid barrier protection in the<br>critical zones of the gown. The back<br>of the Aero Chrome* Breathable<br>Performance Surgical Gown in the<br>non-critical zone has a SMS<br>Spunbond/meltblown/spunbond)<br>fabric that is air-breathable and<br>provides AAMI Level 1 liquid barrier<br>protection. The Aero Chrome*<br>Breathable Performance Surgical<br>Gowns are single use, disposable<br>medical device that will be provided<br>in a variety of sterile and non-sterile<br>packaging configurations described<br>below. | |
| Element of<br>Comparison | Device<br>Description | Subject Device<br>GRI RoyalGuard Surgical Gown,<br>i600, Breathable (i90-61xx-S1) | Predicate Device<br>GRI ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1)<br>K163191 | Reference Device<br>Halyard Aero Chrome Breathable<br>Performance Surgical Gown (4467x)<br>K153255 | |
| Technological Characteristics (cont.) | | The RoyalGuard Surgical Gown, i600,<br>Breathable is constructed with a tri-<br>laminate base material BVB in the<br>gown front and sleeve, and the back<br>is constructed with a single layer of<br>SMS (polyolefin nonwoven). | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced is constructed<br>with base material SMS throughout<br>the entire gown. | The Aero Chrome* Breathable<br>Performance Surgical Gowns have a<br>Spunbond/ Film/ Spunbond/<br>Meltblown/ Spunbond design<br>(SFSMS) that provides AAMI Level 4<br>liquid barrier protection in the<br>critical zones of the gown. The back<br>of the Aero Chrome* Breathable<br>Performance Surgical Gown in the<br>non-critical zone has a SMS<br>Spunbond/meltblown/spunbond)<br>fabric that is air-breathable and<br>provides AAMI Level 1 liquid barrier<br>protection. | |
| | Design<br>Differences | The RoyalGuard Surgical Gown,<br>i600, Breathable has an additional<br>film reinforcement layer in the<br>sleeve critical zone. There is no<br>reinforcement in the front body. | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced has another<br>film reinforcement layer glued to the<br>front and sleeve critical zones. | | |
| | Predicate<br>Comparison | With the construction and material<br>difference to the predicate device,<br>the barrier performance of the<br>subject device is tested and met the<br>AAMI Level 4 liquid barrier<br>performance requirements and<br>passed ISO 10993-1 biocompatibility<br>requirements, and therefore the<br>differences do not raise safety nor<br>effectiveness concerns. | Predicate- This device is classified as<br>a level 4 surgical gown in the critical<br>zones per K163191 submission. | Reference Device - this device is a<br>level 4 surgical gown per K153255<br>submission, and is used as the<br>reference device for "breathable"<br>claim reference. | |
| Element of<br>Comparison | Device<br>Description | Subject Device<br>GRI RoyalGuard Surgical Gown, i600,<br>Breathable (i90-61xx-S1)…
