(116 days)
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 AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
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.
This document describes the premarket notification (510(k)) for the RoyalGuard Surgical Gown, i600, Breathable. The core of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The acceptance criteria and device performance are based on physical and barrier performance testing, not an AI/human reader study for diagnostic accuracy. Therefore, several of the requested sections related to AI performance, expert consensus, and MRMC studies are not applicable.
Here's the information as it applies to this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" primarily refer to adherence to established national and international standards for surgical gowns, and "device performance" refers to the results of testing against those standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (RoyalGuard Surgical Gown, i600, Breathable) |
|---|---|
| Liquid Barrier Performance: | |
| AAMI PB70:2012, Level 4 (Critical Zones) - ASTM F1671-13 (Viral Penetration, Pass/Fail) | Passed ANSI/AAMI PB 70:2012 Level 4 requirements for all fabrics, seams, and attachments in the critical zones. |
| AAMI PB70:2012, Level 1 (Non-Critical Zones) - AATCC 42-2013 (Impact Penetration) | Passed ANSI/AAMI PB 70:2012 Level 1 requirements for all fabrics, seams, and attachments in the non-critical zones. |
| Biocompatibility: | |
| ISO 10993-5 (Cytotoxicity) | Non-cytotoxic |
| ISO 10993-10 (Sensitization) | Non-sensitizing |
| ISO 10993-10 (Irritation) | Non-irritating |
| Flammability: | |
| 16 CFR Part 1610 (2014) | Met Class 1 requirement. |
| Physical Properties (Internal Specifications): | |
| ASTM D3776 (2009) Basis Weight (gsm) | Passed internal specification requirements for all fabrics. |
| ASTM D5034-09 (2013) Grab Tensile (Newton) | Passed internal specification requirements for all fabrics. |
| ASTM D5587 (2015) Trapezoid Tear (Newton) | Passed internal specification requirements for all fabrics. |
| ASTM D1683 (2016) Seam Strength (Newton) | Passed internal specification requirements for all seams. |
| ASTM E96 (2016) WVTR (Water Vapor Transmission Rate) | The front material passed internal specification requirement (used for "breathable" claim, compared to a reference device). |
2. Sample size used for the test set and data provenance:
- Sample Size: The document does not specify exact sample sizes (number of gowns or material samples) for each test. Medical device testing is typically performed on a statistically relevant number of samples to ensure representativeness and consistency.
- Data Provenance: The testing was conducted by GRI Medical & Electrical Technology Co., Ltd. (the applicant/manufacturer). The nature of the testing (physical and barrier performance) strongly suggests these were prospective lab tests performed on manufactured samples of the RoyalGuard Surgical Gown. The country of origin for the data generation would be China, where the manufacturer is located, given the contact information provided (JiaXing, ZheJiang, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical and biological performance study for a surgical gown, not an AI/diagnostic imaging study. Ground truth is established by standardized test methods (e.g., AAMI PB70, ASTM, ISO standards) and objective measurements performed in a lab setting, not by expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set:
- Not Applicable. As this is not a study involving human interpretation or subjective assessment, adjudication methods are not relevant. Test results are quantitative measurements against established pass/fail criteria from recognized standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
- The "ground truth" for this device is based on objective measurements from performance standards and laboratory testing. For example:
- AAMI PB70:2012 (Liquid Barrier Performance): This standard defines specific tests (e.g., ASTM F1671 for viral penetration, AATCC 42 for impact penetration) with quantitative pass/fail criteria to classify gown barrier levels. The ground truth is the measured resistance to fluid and viral penetration.
- ISO 10993 (Biocompatibility): This set of standards uses in vitro and in vivo tests to assess materials for cytotoxicity, sensitization, and irritation. The ground truth is the observed biological response (or lack thereof) to the material.
- 16 CFR Part 1610 (Flammability): This standard defines methods to test flammability and classifies materials based on burn rate. The ground truth is the measured flammability.
- ASTM Physical Properties: These standards define methods for measuring material properties like basis weight, tensile strength, tear strength, and seam strength. The ground truth is the measured physical property.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against performance standards.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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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)
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/QA1805 HongGao RoadXiuZhou Industry ZoneJiaXing, ZheJiang, China, 314031Tel: 86-135-1135-9722Email: mpaugh@gri-china.com |
| Official Correspondent: | Harry Shaffer, PresidentSterilization Consulting Services LLC10051 Oak Leaf way, Highlands Ranch, CO 80129Tel: 303-929-3808Email: 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 §878.4040General and plastic surgeryProduct Code: FYA |
| Predicate Device:Reference Device | GRI ComfortGuard Surgical Gown, i600, Film Reinforced (K163191)Halyard Aero Chrome Breathable Performance Surgical Gown(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 withoutThumb-hooks | Model Code withThumb-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 | ||||
| WithoutThumb-hook | WithThumb-hook | WithoutThumb-hook | WithThumb-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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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 ofComparison | DeviceDescription | Subject DeviceGRI RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero Chrome BreathablePerformance Surgical Gown(4467x)K153255 | |
|---|---|---|---|---|---|
| General | Manufacturer | GRI | GRI | Halyard | |
| ProductTrade Name | RoyalGuard Surgical Gown, i600,Breathable | ComfortGuard Surgical Gown, i600,Film Reinforced | Aero Chrome BreathablePerformance Surgical Gown | ||
| Classification# | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | ||
| ClassificationName | Surgical Apparel | Surgical Apparel | Surgical Apparel | ||
| Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | ||
| AAMI PB 70Classification | Level 4 | Level 4 | Level 4 | ||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | ||
| Comparison | Subject device is substantiallyequivalent to the predicate inclassification and sterilizationmethod. | Predicate Device- This device is alevel 4 Film-Reinforced surgicalgown per K163191 submission, andis used as the predicate. | Reference Device – this device is alevel 4 surgical gown per K153255submission, and is used as thereference device for "breathable"claim reference. | ||
| Indications for Use | |||||
| Element ofComparison | DeviceDescription | Subject DeviceGRI RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero Chrome BreathablePerformance Surgical Gown (4467x)K153255 | |
| Indications for Use | Indicationsfor Use | The RoyalGuard Surgical Gown, i600,Breathable is a single use surgicalgown intended to protect surgicalpatients and operating roompersonnel from the transfer ofmicroorganisms, body fluids, andparticulate material.The RoyalGuard Surgical Gown, i600,Breathable has been tested and isclassified as Level 4 in the criticalzones per AAMI Standard PB70Liquid barrier performance andclassification of protective appareland drapes intended for use inhealthcare facilities. | The ComfortGuard Surgical Gown,i600, Film Reinforced is a single usesurgical gown intended to protectsurgical patients and operatingroom personnel from the transfer ofmicroorganisms, body fluids, andparticulate material.The ComfortGuard Surgical Gown,i600, Film Reinforced has beentested and is classified as Level 4 inthe critical zones per AAMI StandardPB70 Liquid barrier performanceand classification of protectiveapparel and drapes intended for usein healthcare facilities. | The Aero Chrome* BreathablePerformance Surgical Gowns aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect boththe patient and the healthcareworker from the transfer ofmicroorganisms, body fluids, andparticulate matter.The Aero Chrome* BreathablePerformance Surgical Gowns meetthe Level 4 requirements of theAAMI PB70:2012 Liquid Barrierclassifications.The Aero Chrome* BreathablePerformance Surgical Gowns arealso sold as bulk non-sterile, singleuse items, to repackager/relabelerestablishments for further packagingand Ethylene Oxide (EtO)sterilization. | |
| Comparison | Subject device is substantiallyequivalent to the predicate in itsindications for use. The subjectdevice and predicate are Level 4 | Predicate Device- This device is alevel 4 Film-Reinforced surgicalgown per K163191 submission, andis used as the predicate. | Reference Device - this device is alevel 4 surgical gown per K153255submission, and is used as thereference device for "breathable"claim reference. | ||
| Element ofComparison | DeviceDescription | Subject DeviceGRI RoyalGuard Surgical Gown, i600,Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown, i600, FilmReinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero ChromeBreathable PerformanceSurgical Gown (4467x)K153255 | |
| Technological Characteristics | Device Description | The RoyalGuard Surgical Gown, i600, Breathable(i90-61xx-S1) consists of a tri-laminate fabricBreathable Viral Barrier (BVB) including an outerand inner layer of spunbond polyolefin fabricwith a middle layer of breathable monolithic filmin the gown front body and gown sleeves. Thegown sleeves critical zones also consist of anadditional layer of Film Reinforcement Bi-laminate material, including a layer of spunbondand a layer of film. The gown back panels arecomprised of a single layer of SMS (polyolefinnonwoven).The RoyalGuard Surgical Gown, i600, Breathable(i90-61xx-S1) is provided with neck binder, hookand loop tabs, belt ties, removable transferaccessory, and cuffs.The RoyalGuard Surgical Gown, i600, Breathable(i90-61xx-S1) has been tested according to AAMIPB70:2012 and met the AAMI Level 4 liquidbarrier performance requirements. It isconstructed with or without thumb-hooks incuffs. The addition of thumb-hooks does notimpact the performance of the gown inaccordance with AAMI PB70 requirement. | The ComfortGuard Surgical Gown, i600, FilmReinforced (i90-82xx-S1) consists of a multi-layerin the critical zones (SMS & Film Lamination),single layer of SMS (polyolefin nonwoven) in thenon-critical zones in the body and sleeve, singlelayer of SMS (polyolefin nonwoven) in the backpanel with a lower basis weight SMS.The ComfortGuard Surgical Gown, i600, FilmReinforced (i90-82xx-S1) is provided with neckbinder, hook and loop tabs, belt ties, removabletransfer accessory, and cuffs.The ComfortGuard Surgical Gown, i600, FilmReinforced (i90-82xx-S1) has been testedaccording to AAMI PB70:2012 and met the AAMILevel 4 liquid barrier performance requirements.It is constructed with or without thumb-hooks incuffs, with pleats in the back panels, with a lowerbasis weight SMS in the back panel. The additionof thumb-hooks, back pleats, and the use of alighter basis weight material in the back panelsdoes not impact the performance of the gown inaccordance with AAMI PB70 requirement. | The Aero Chrome* BreathablePerformance Surgical Gowns have aSpunbond/ Film/ Spunbond/Meltblown/ Spunbond design(SFSMS) that provides AAMI Level 4liquid barrier protection in thecritical zones of the gown. The backof the Aero Chrome* BreathablePerformance Surgical Gown in thenon-critical zone has a SMSSpunbond/meltblown/spunbond)fabric that is air-breathable andprovides AAMI Level 1 liquid barrierprotection. The Aero Chrome*Breathable Performance SurgicalGowns are single use, disposablemedical device that will be providedin a variety of sterile and non-sterilepackaging configurations describedbelow. | |
| Element ofComparison | DeviceDescription | Subject DeviceGRI RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero Chrome BreathablePerformance Surgical Gown (4467x)K153255 | |
| Technological Characteristics (cont.) | The RoyalGuard Surgical Gown, i600,Breathable is constructed with a tri-laminate base material BVB in thegown front and sleeve, and the backis constructed with a single layer ofSMS (polyolefin nonwoven). | The ComfortGuard Surgical Gown,i600, Film Reinforced is constructedwith base material SMS throughoutthe entire gown. | The Aero Chrome* BreathablePerformance Surgical Gowns have aSpunbond/ Film/ Spunbond/Meltblown/ Spunbond design(SFSMS) that provides AAMI Level 4liquid barrier protection in thecritical zones of the gown. The backof the Aero Chrome* BreathablePerformance Surgical Gown in thenon-critical zone has a SMSSpunbond/meltblown/spunbond)fabric that is air-breathable andprovides AAMI Level 1 liquid barrierprotection. | ||
| DesignDifferences | The RoyalGuard Surgical Gown,i600, Breathable has an additionalfilm reinforcement layer in thesleeve critical zone. There is noreinforcement in the front body. | The ComfortGuard Surgical Gown,i600, Film Reinforced has anotherfilm reinforcement layer glued to thefront and sleeve critical zones. | |||
| PredicateComparison | With the construction and materialdifference to the predicate device,the barrier performance of thesubject device is tested and met theAAMI Level 4 liquid barrierperformance requirements andpassed ISO 10993-1 biocompatibilityrequirements, and therefore thedifferences do not raise safety noreffectiveness concerns. | Predicate- This device is classified asa level 4 surgical gown in the criticalzones per K163191 submission. | Reference Device - this device is alevel 4 surgical gown per K153255submission, and is used as thereference device for "breathable"claim reference. | ||
| Element ofComparison | DeviceDescription | Subject DeviceGRI RoyalGuard Surgical Gown, i600,Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero Chrome BreathablePerformance Surgical Gown(4467x)K153255 | |
| Technological Characteristics (cont.) | MaterialComposition | A tri-laminate fabric Breathable ViralBarrier (BVB) in the entire front andsleeve, additional Film reinforcementlayer glued to the sleeve critical zones,single layer of SMS (polyolefinnonwoven) in back panels | Multi-layer in the critical zones(SMS & Film Lamination), singlelayer of SMS (polyolefin nonwoven)in the non-critical zones in the bodyand sleeve, single layer of SMS(polyolefin nonwoven) in the backpanel with a lower basis weightSMS. | The Aero Chrome* BreathablePerformance Surgical Gowns have aSpunbond/ Film/ Spunbond/Meltblown/ Spunbond design(SFSMS) in the critical zones of thegown. The back of the AeroChrome* Breathable PerformanceSurgical Gown in the non-criticalzone has a SMS Spunbond/meltblown/spunbond) fabric. | |
| MaterialAdditives | Anti-Static throughout the entire gown | Alcohol-Repellency to Front Bodyand Sleeve materialsAnti-Static throughout the entiregown | NA | ||
| PredicateComparison | With the exception of the materialcomposition difference to the predicatedevice; The barrier performance of thesubject device met the AAMI Level 4liquid barrier performance requirementsand passed ISO 10993-1 biocompatibilityrequirements, and therefore thedifferences do not raise safety noreffectiveness concerns. | Predicate Device- This device isclassified as a level 4 surgical gownin the critical zones and passedISO10993-1 biocompatibilityrequirements per K163191submission. | Reference Device - this device is alevel 4 surgical gown per K153255submission, and is used as thereference device for "breathable"claim reference. | ||
| Element ofComparison | Device Description | Subject DeviceGRI RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)K163191 | Reference DeviceHalyard Aero Chrome BreathablePerformance Surgical Gown(4467x)K153255 | |
| 16 CFR Part 1610(2014)Flammability | Tested and met Class 1requirement | Tested and met Class 1requirement per K163191submission | Tested and met Class 1requirement per K153255submission | ||
| Safety Properties | Biocompatibility | Testing was performed accordingto ISO 10993-5 and ISO 10993-10.Under the conditions of eachstudy, the device is non-cytotoxic,non-sensitizing and non-irritating. | Testing was performed accordingto ISO 10993-5 and ISO 10993-10.Under the conditions of eachstudy, the device is non-cytotoxic,non-sensitizing and non-irritating.per K163191 submission | Tested under ISO 10993 andpassed. Under the conditions ofthe study, the device is non-cytotoxic, non-sensitizing and non-irritating. per K153255 submission | |
| Comparison | The RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1) issubstantially equivalent to thepredicate in safety properties interms of Flammability andbiocompatibility performance. | Predicate Device – This devicemeets Class 1 Flammability andBiocompatibility requirements perK163191 submission. | |||
| Liquid Barrier Performance Classification Properties | Element ofComparison | Device Description | Subject DeviceGRI RoyalGuard SurgicalGown, i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard SurgicalGown, i600, Film Reinforced(i90-82xx-S1)K163191 | Reference DeviceHalyard Aero ChromeBreathable PerformanceSurgical Gown (4467x)K153255 |
| Critical Zones | AAMI PB70 ASTMF1671-13 ViralPenetration (Pass/Fail)Level 4 requirement | All fabrics, seams andattachments in the criticalzones passed ANSI/AAMI PB70: 2012 Level 4 requirements | All fabrics, seams andattachments in the criticalzones passed ANSI/AAMI PB70: 2012 Level 4 requirementsper K163191 submission | ANSI/AAMI PB70: 2012Level 4 Liquid BarrierRequirements - Pass perK153255 submission. | |
| Non-Critical Zone(cont.) | AAMI PB70 AATCC 42-2013 ImpactPenetration (grams)Non-Critical ZoneLevel 1 Requirements | All fabrics, seams andattachments in the non-criticalzones passed ANSI/AAMI PB70: 2012 Level 1 requirements | All fabrics, seams andattachments in the non-criticalzones passed ANSI/AAMI PB70: 2012 Level 1 requirementsper K163191 submission | All fabrics, seams andattachments in the non-critical zones passedANSI/AAMI PB 70: 2012Level 1 requirements perK153255 submission. | |
| Comparison | The RoyalGuard Surgical Gown,i600, Breathable (i90-61xx-S1)meets AAMI PB70 Level 4requirements at critical zonesand level 1 requirements atNon-Critical Zones andtherefore is substantiallyequivalent to the predicate. | Predicate Device - TheComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1) meets AAMI PB70 Level 4requirements at critical zonesand meets PB70 level 1requirements at Non-CriticalZones per K163191 submission. | Reference Device - thisdevice meets ANSI/AAMIPB70: 2012 Level 4 LiquidBarrier Requirements inthe critical zones and Level1 requirement in the non-critical zones per K153255submission. | ||
| Element ofComparison | Device Description | Subject DeviceGRI RoyalGuard SurgicalGown, i600, Breathable (i90-61xx-S1) | Predicate DeviceGRI ComfortGuard SurgicalGown, i600, Film Reinforced(i90-82xx-S1)K163191 | Reference DeviceHalyard Aero ChromeBreathable PerformanceSurgical Gown (4467x)K153255 | |
| PhysicalProperties(cont.) | ASTM D3776 (2009) BasisWeight (gsm)GRI Specifications | All fabrics passed internalspecification requirements | All fabrics passed internalspecification requirements perK163191 submission | NA | |
| ASTM D5034-09 (2013)Grab Tensile (Newton)GRI Specifications | All fabrics passed internalspecification requirements | All fabrics passed internalspecification requirements perK163191 submission | Fabrics in the critical zonespassed specificationrequirements per K153255submission | ||
| ASTM D5587 (2015)Trapezoid Tear (Newton)GRI Specifications | All fabrics passed internalspecification requirements | All fabrics passed internalspecification requirements perK163191 submission | NA | ||
| ASTM D1683 (2016) SeamStrength (Newton)GRI Specifications | All seams passed internalspecification requirements | All seams passed internalspecification requirements perK163191 submission | NA | ||
| ASTM E96 (2016) WVTRGRI Specifications | The front material passedinternal specificationrequirement | NA | Critical zone fabric utilizedWSP 70.4 WVTR methodand passed per K153255submission | ||
| Comparison | The RoyalGuard SurgicalGown, i600, Breathable (i90-61xx-S1) meet thepredetermined specificationsfor all physical properties. | Predicate - The ComfortGuardSurgical Gown, i600, FilmReinforced (i90-82xx-S1) meetthe predeterminedspecifications. | Reference Device - thisdevice is used as thereference device for"breathable" claim. |
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Image /page/7/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized, lowercase font, with a blue crescent shape above the "i". Below the letters, the full name of the company, "Global Resources International," is written in a smaller, sans-serif font. The overall design is clean and professional, suggesting a company involved in global resource management.
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Image /page/8/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters 'gri' in a stylized, lowercase font, with a blue crescent shape 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 corporate, suggesting a professional and international organization.
Technological Characteristics
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Image /page/9/Picture/0 description: The image shows 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 letters. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name.
Technological Characteristics (cont.)
Continue on next page.
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Image /page/10/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters 'gri' in a stylized, italicized font, with the 'i' having a curved extension above it, resembling a crescent moon. Below the letters, the full name of the company, 'Global Resources International,' is written in a smaller, sans-serif font.
Technological Characteristics (cont.)
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Image /page/11/Picture/0 description: The image shows 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.
Safety Properties
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Image /page/12/Picture/0 description: The image shows the logo for Global Resources International. The logo consists of the letters "gri" in a stylized font, with a blue arc above the "i". Below the letters, the words "Global Resources International" are written in a smaller font. The logo is simple and modern, and the use of blue suggests a connection to the environment or technology.
Liquid Barrier Performance Classification Properties
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Image /page/13/Picture/0 description: The image shows the logo for Global Resources International. The logo features the letters "gri" in a stylized, bold, black font, with a blue swoosh above the "i". Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.
Physical Properties
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Image /page/14/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized, lowercase font, with a blue arc above the "i". Below the letters, the full name of the company, "Global Resources International," is written in a smaller, sans-serif font.
1.2 Conclusion of the tests
Based on the results of the biocompatibility and physical performance testing, the GRI RoyalGuard Surgical Gown, i600-61xx-S1) is as safe and as effective, and as performs as well as the predicate device.
§ 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.