(105 days)
The ComfortGuard Surgical Gown, i600, Film Reinforced 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 ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-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 nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) 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, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
Here's a breakdown of the acceptance criteria and study information for the ComfortGuard Surgical Gown, i600, Film Reinforced, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the AAMI PB70 standard for liquid barrier performance, along with other ASTM and ISO standards for physical properties and biocompatibility.
| Test / Performance Metric | Acceptance Criteria | Reported Device Performance (ComfortGuard Surgical Gown, i600, Film Reinforced) |
|---|---|---|
| AAMI PB70 & ASTM F1671-13 Viral Penetration (Critical Zones) - Level 4 Requirements | A1: Base Material: PassA2: Tie Attachment: PassB1: Lower Sleeve Seam: PassB2: Upper Sleeve Seam: PassAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | A1: Base Material: PASSA2: Tie Attachment: PASSB1: Lower Sleeve Seam: PASSB2: Upper Sleeve Seam: PASS (Results obtained from three independent Lots) (Implicitly meets AQL/RQL given "PASS" results) |
| AATCC 42-2013 Impact Penetration (Non-Critical Zone) - Level 1 Requirements | C1: Base Material: ≤4.5gC2: Sleeve Joint Sewn Seam: ≤4.5gC3: Sleeve Seam: ≤4.5gAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | C1: Base Material: 0.03grams (0.00, 0.08)C2: Sleeve Joint Sewn Seam: 2.26grams (0.07, 4.42)C3: Sleeve Seam: 0.00grams (0.00, 0.05) (Results obtained from three Lots) (Implicitly meets AQL/RQL given numerical results are well below the criteria) |
| AATCC 42-2013 Impact Penetration (Non-Critical Zone - Back) - Level 1 Requirements | D1: Base Material: ≤4.5gD2: Back Joint Sewn Seam: ≤4.5gD3: Back Tie Attachment: ≤4.5gAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | D1: Back- Base Material: 1.00grams (0.07, 4.31)D2: Back Joint Sewn Seam: 2.54grams (0.21, 4.48)D3: Back Tie Attachment: 0.89grams (0.00, 4.47) (Results obtained from three Lots) (Implicitly meets AQL/RQL given numerical results are well below the criteria) |
| 16 CFR Part 1610 (2014) Flammability | Meets Class 1 requirement | Tested and met Class 1 requirement |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Device is non-cytotoxic, non-sensitizing, and non-irritating | Under the conditions of each study, the device is non-cytotoxic, non-sensitizing and non-irritating (Passed all tests). |
| ASTM D3776 (2009) Basis Weight (gsm) | Critical zone - Body/Sleeve Material: Mean =102gsm (-10, +10)Non-Critical zone- Body/Sleeve Material: Mean =47gsm (-5, +5)Back Material: Mean =33gsm (-3, +3) | Critical zone - Body/Sleeve Material: 109.5gsm (103.0, 118.0)Non-Critical zone- Body/Sleeve Material: 49.3gsm (47.0, 52.0)Back Material: 33.9gsm (32.0, 36.0) (Results obtained from Three Lots) (All reported mean values are within the specified ranges) |
| ASTM D5034-09 (2013) Grab Tensile (Newton) | Critical Zone Body/Sleeve Material MD: Mean MD ≥ 100NCritical Zone Body/Sleeve Material CD: Mean CD ≥ 70NNon-Critical Zone Body/Sleeve Material MD: Mean MD ≥ 40NNon-Critical Zone Body/Sleeve Material CD: Mean CD ≥ 20NBack Material MD: Mean MD ≥ 40NBack Material CD: Mean CD ≥ 20N | Critical Zone Body/Sleeve Material MD: 170.0N (151.6, 186.7)Critical Zone Body/Sleeve Material CD: 141.5N (115.4, 166.8)Non-Critical Zone Body/Sleeve Material MD: 95.9N (85.2, 107.9)Non-Critical Zone Body/Sleeve Material CD: 61.3N (53.4, 70.9)Back Material MD: 82.6N (62.5, 101.5)Back Material CD: 56.7N (43.1, 67.2) (Results obtained from Three Lots) (All reported mean values are well above the minimum required) |
| ASTM D5587 (2014) Trapezoid Tear (Newton) | Critical Zone Body/Sleeve Material MD: Mean MD ≥ 20NCritical Zone Body/Sleeve Material CD: Mean CD ≥ 40NNon-Critical Zone Body/Sleeve Material MD: Mean MD ≥ 10NNon-Critical Zone Body/Sleeve Material CD: Mean CD ≥ 20NBack Material MD: Mean MD ≥ 10NBack Material CD: Mean CD ≥ 20N | Critical Zone Body/Sleeve Material MD: 57.3N (42.8, 73.2)Critical Zone Body/Sleeve Material CD: 75.0N (62.1, 88.3)Non-Critical Zone Body/Sleeve Material MD: 16.5N (13.2, 21.4)Non-Critical Zone Body/Sleeve Material CD: 25.4N (20.9, 34.9)Back Material MD: 20.7N (14.4, 28.4)Back Material CD: 33.3N (24.9, 46.1) (Results obtained from Three Lots) (All reported mean values are above the minimum required) |
| ASTM D1683 (2007) Seam Strength (Newton) | Outer Sleeve seam: Min ≥20 NInner Sleeve seam: Min ≥50 N | Outer Sleeve Seam: 47.4N (21.0, 60.2)Inner Sleeve Seam: 90.4N (75.2, 106.0) (Results obtained from Three Lots) (Both reported min values meet or exceed the minimum required) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size:
- For the AAMI PB70 / ASTM F1671-13 (Viral Penetration) and AATCC 42-2013 (Impact Penetration) tests, the specified sample size is n=32 for each critical zone/material type, with an acceptance quality limit (AQL) of 4% and a rejection quality limit (RQL) of 20%.
- For the physical property tests (Basis Weight, Grab Tensile, Trapezoid Tear, Seam Strength), results are reported as "Results obtained from Three Lots" for Mean (Min, Max). The specific sample size per lot for these tests is not explicitly stated, but implies multiple samples were taken across these three lots.
- Data Provenance:
- The document does not explicitly state the country of origin of the data for these performance tests. Given that the manufacturer is "GRI Medical & Electronic Technology Co., Ltd." located in JiaXing, China, it is plausible the testing was performed in China or by labs contracted by the manufacturer.
- The studies described are prospective in nature, as they involve testing the manufactured device according to specific standards to determine its performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This document describes performance testing of a physical medical device (surgical gown) against recognized industry standards (AAMI PB70, ASTM, ISO).
- No human experts are used to establish "ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images). Instead, the "ground truth" is established by the standardized testing methodologies themselves, which provide objective, measurable results (e.g., pass/fail for viral penetration, grams for impact penetration, Newtons for tensile strength).
- The "experts" involved would be the certified laboratory technicians performing these tests, who are qualified to conduct tests according to the specified ASTM/ISO/AAMI standards. Their specific qualifications (e.g., years of experience) are not detailed in this summary.
4. Adjudication Method for the Test Set
- None. As explained above, the tests are objective, quantifiable physical and barrier performance assessments governed by specific standards. The results are not subject to human interpretation or adjudication in the way that, for example, diagnostic image reviews would be. The acceptance/rejection criteria are pre-defined by the AQL/RQL and specific performance thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on clinical decision-making. This document describes the performance of a surgical gown, which is a physical barrier device, not a diagnostic tool requiring human interpretation.
6. If a Standalone (algorithm only without human-in-the loop performance) was done
- Not applicable. This question pertains to AI-powered diagnostic algorithms. The ComfortGuard Surgical Gown is a physical medical device; there is no "algorithm" or "human-in-the-loop" aspect to its performance evaluation beyond standard quality control and testing procedures for manufactured goods.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of the surgical gown is established by objective, quantitative measurements performed according to internationally recognized standards and specifications. These include:
- Standardized Test Results for Barrier Performance: Meeting "Pass" criteria for viral penetration (ASTM F1671-13) and having impact penetration values below specified thresholds (AATCC 42-2013), as outlined in AAMI PB70.
- Standardized Test Results for Physical Properties: Meeting or exceeding specified minimums or ranges for Basis Weight (ASTM D3776), Grab Tensile (ASTM D5034-09), Trapezoid Tear (ASTM D5587), and Seam Strength (ASTM D1683).
- Biocompatibility Testing: Demonstrating non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993-5 and ISO 10993-10.
- Flammability Testing: Meeting Class 1 requirements as per 16 CFR Part 1610 (2014).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is implicitly "trained" through process controls and quality management, but not data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that form the head, body, and tail of the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27. 2017
Gri Medical & Electrical Technology Co., Ltd. % Harry Shaffer President Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, Colorado 80129
Re: K163191
Trade/Device Name: Comfortguard Surgical Gown, i600, Film Reinforced Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 20, 2017 Received: February 6, 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Susan Runno DDS, MA
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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Indications for Use
510(k) Number (if known) K163191
Device Name
ComfortGuard Surgical Gown, i600, Film Reinforced
Indications for Use (Describe)
The ComfortGuard Surgical Gown, i600, Film Reinforced 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 ComfortGuard Surgical Gown, i600, Film Reinforced 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.
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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SECTION C Summary
1 510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92.
| Date: | January 20th, 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: | ComfortGuard Surgical Gown, i600, Film Reinforced |
| 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: | Kimberly-Clark ULTRA Film-Reinforced Surgical Gown(K080795) |
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Description of the Device 1.1
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-51) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-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 nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) 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, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
1.2 Indications for Use
The ComfortGuard Surgical Gown, i600, Film Reinforced 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 ComfortGuard Surgical Gown, i600, Film Reinforced 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 C 1 Product List
| Product List | ||
|---|---|---|
| Product Name | Model Code withoutThumb-hooks | Model Code withThumb-hooks |
| ComfortGuard Surgical Gown, i600, Film Reinforced | i90-82xx-S1 | i90-82xxT-S1 |
| i90-82xx | i90-82xxT |
Table C 2 Key for Surgical Gown Codes
| Key for Surgical Gown Codes: | |
|---|---|
| Prefix | 90= Surgical gown with Set-In sleeve |
| Suffix - 1 | First position represents base "fabric" |
| 8 = 47gsm SMS | |
| Suffix - 2 | Second position represents "reinforcement" |
| 0 = None | |
| 2 = Film reinforcement | |
| Suffix - 3(x) | Third position represents "size" |
| 0 = Small | |
| 1 = Medium | |
| 2 = Large | |
| 3 = XL | |
| 4 = XXL | |
| Suffix - 4(x) | Fourth position represents "length" |
| 0 = Standard | |
| 2 = XLong | |
| 4 = A-frame | |
| Suffix - 5 | Fifth position represents "Thumb-hooks" |
| T = with thumb-hooks | |
| Suffix - 6 | Sixth position represents "packaging" |
| S1 = Sterile |
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Image /page/6/Picture/0 description: The image contains the logo for Global Resources International, with the acronym "gri" in a stylized font. Below the logo, the text "Global Resources International" is printed in a smaller font. The image also includes the text "Table C 3- Product Catalog Number and Description".
| Catalog # | |||||
|---|---|---|---|---|---|
| Sterile | Non-Sterile | ||||
| Without Thumb-hook | With Thumb-hook | Without Thumb-hook | With Thumb-hook | Model Description | Size |
| i90-8200-S1 | i90-8200T-S1 | i90-8200 | i90-8200T | ComfortGuard Surgical Gown, i600, Film Reinforced | S |
| i90-8210-S1 | i90-8210T-S1 | i90-8210 | i90-8210T | ComfortGuard Surgical Gown, i600, Film Reinforced | M |
| i90-8220-S1 | i90-8220T-S1 | i90-8220 | i90-8220T | ComfortGuard Surgical Gown, i600, Film Reinforced | L |
| i90-8230-S1 | i90-8230T-S1 | i90-8230 | i90-8230T | ComfortGuard Surgical Gown, i600, Film Reinforced | XL |
| i90-8240-S1 | i90-8240T-S1 | i90-8240 | i90-8240T | ComfortGuard Surgical Gown, i600, Film Reinforced | XXL |
| i90-8222-S1 | i90-8222T-S1 | i90-8222 | i90-8222T | ComfortGuard Surgical Gown, i600, Film Reinforced | L-XLONG |
| i90-8232-S1 | i90-8232T-S1 | i90-8232 | i90-8232T | ComfortGuard Surgical Gown, i600, Film Reinforced | XL-XLONG |
| i90-8242-S1 | i90-8242T-S1 | i90-8242 | i90-8242T | ComfortGuard Surgical Gown, i600, Film Reinforced | XXL-XLONG |
| i90-8224-S1 | i90-8224T-S1 | i90-8224 | i90-8224T | ComfortGuard Surgical Gown, i600, Film Reinforced | A-frame, L-XLONG |
| i90-8234-S1 | i90-8234T-S1 | i90-8234 | i90-8234T | ComfortGuard Surgical Gown, i600, Film Reinforced | A-frame, XL-XLONG |
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1.1 Summary of technological characteristics compared to the predicate
A side by side table between both proposed devices and predicate device is provided in below table.
Table C 4 Side by Side Comparison of Proposed Devices and Predicate Device
General Information
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gown,code 954xx, 955xx(K080795) | Kimberly-Clark ULTRA SurgicalGowncode 951xx(K080795) |
|---|---|---|---|---|
| General | Manufacturer | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. |
| Product TradeName | ComfortGuard Surgical Gown,i600, Film Reinforced | ULTRA Film-Reinforced SurgicalGown | ULTRA Surgical Gown | |
| Classification # | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | |
| Classification Name | 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 3 | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| PredicateComparison | Subject device is substantiallyequivalent to the predicate inclassification and sterilizationmethod. | Predicate- This device is a level 4Film-Reinforced surgical gown perK080795 submission, and is usedas the predicate. The subjectdevice is substantially equivalentto this gown for their indicationsfor use. | This Device is a Level 3 non-reinforced surgical gown perK080795 submission. Subjectdevice is not substantiallyequivalent to this gown. Thisgown is not considered as apredicate. | |
| Element ofComparison | DeviceDescription | ComfortGuard Surgical Gown, i600,Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code954xx, 955xx(K080795) | Kimberly-Clark ULTRA Surgical Gown,code 951xx(K080795) |
| Indications for Use | Indications for Use | The ComfortGuard Surgical Gown,i600, Film Reinforced is a single usesurgical gown intended to protectsurgical patients and operating roompersonnel from the transfer ofmicroorganisms, body fluids, andparticulate material.The ComfortGuard Surgical Gown,i600, Film Reinforced has been testedand is classified as Level 4 in thecritical zones per AAMI Standard PB70Liquid barrier performance andclassification of protective apparel anddrapes intended for use in healthcarefacilities. | The Kimberly-Clark ULTRA SurgicalGowns and ULTRA Film-ReinforcedSurgical Gowns are sterile, single usesurgical gown intended to protectboth the surgical patient and theoperating room personnel from thetransfer of microorganisms, bodyfluids and particulate material.The ULTRA Surgical Gowns meet Level3 of the AAMI Liquid Barrierclassifications, and the ULTRA Film-Reinforced Surgical Gowns meet Level4 of the AAMI Liquid Barrierclassifications. | The Kimberly-Clark ULTRA SurgicalGowns and ULTRA Film-ReinforcedSurgical Gowns are sterile, single usesurgical gown intended to protectboth the surgical patient and theoperating room personnel from thetransfer of microorganisms, bodyfluids and particulate material.The ULTRA Surgical Gowns meet Level3 of the AAMI Liquid Barrierclassifications, and the ULTRA Film-Reinforced Surgical Gowns meet Level4 of the AAMI Liquid Barrierclassifications. |
| PredicateComparison | Subject device is substantiallyequivalent to the predicate in itsindications for use. The subject deviceand predicate are Level 4 surgicalgowns. | Predicate- This device is a level 4 Film-Reinforced surgical gown per K080795submission, and is used as thepredicate. | This Device is a Level 3 non-reinforcedsurgical gown per K080795submission. Subject device is notsubstantially equivalent to this gown.This gown is not considered as apredicate. | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown, i600,Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gown,code 954xx, 955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code 951xx(K080795) |
| Technological Characteristics | Device Description | The ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)consists of a multi-layer in the criticalzones (SMS & Film Lamination),single layer of SMS (polyolefinnonwoven) in the non-critical zonesin the body and sleeve, single layer ofSMS (polyolefin nonwoven) in theback panel with a lower basis weightSMS. | Predicate Kimberly-Clark ULTRAFilm-Reinforced Gown is a full-length, nonwoven SMSpolypropylene gown. The ULTRAFilm-Reinforced Surgical Gown isfilm-reinforced for higher barrierprotection. | Kimberly-Clark ULTRA Gownis a full-length, nonwovenSMS polypropylene gown. |
| ComfortGuard Surgical Gown, i600,Film Reinforced (i90-82xx-S1) isprovided with neck binder, hook andloop tabs, belt ties, removabletransfer accessory, and cuffs. | Predicate Kimberly-Clark ULTRAFilm-Reinforced Gown isconstructed with raglan sleeves,hook-and-loop neck closures,and tie waist closures. | Kimberly-Clark ULTRA Gownis constructed with raglansleeves, hook-and-loop neckclosures, and tie waistclosures. |
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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 bold, sans-serif font, with the "i" having a curved extension above it. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.
Indications for Use
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Technological Characteristics
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| Technological Characteristics (cont.) | ||||
|---|---|---|---|---|
| Element ofComparison | Device Description | ComfortGuard Surgical Gown, i600,Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gown,code 954xx, 955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code 951xx(K080795) |
| Design Differences | The ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1) isconstructed with or without thumb-hooks in cuffs. | Predicate Kimberly-Clark ULTRAFilm-Reinforced Gown does nothave thumb-hooks in cuffs. | Kimberly-Clark ULTRASurgical Gown does nothave thumb-hooks in cuffs. | |
| The ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1) isconstructed with pleats in the backpanels. | Predicate Kimberly-Clark ULTRAFilm-Reinforced Gown is notconstructed with pleats in theback. | Kimberly-Clark ULTRASurgical Gown is notconstructed with pleats inthe back. | ||
| Predicate Comparison | The addition of thumb-hooks, backpleats, and the use of a lighter basisweight material in the back panelsdoes not impact the performance ofthe gown in accordance with AAMIPB70 requirement, and therefore issubstantially equivalent to thepredicate. | The predicate Kimberly-ClarkULTRA Film-Reinforced SurgicalGown does not include theseDesign features | The Kimberly-Clark ULTRASurgical Gown does notinclude these Designfeatures | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gown,code 954xx, 955xx(K080795) | Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) |
| Technological Characteristics (cont.) | Material Composition | Multi-layer in the critical zones(SMS & Film Lamination), singlelayer of SMS (polyolefinnonwoven) in the non-criticalzones in the body and sleeve,single layer of SMS (polyolefinnonwoven) in the back panelwith a lower basis weight SMS. | Multi-layer construction (SMS &Film lamination) in the entirefront body and sleeve, singlelayer of SMS (polyolefinnonwoven) in back panels | Single Layer of SMS (polyolefinnonwoven) throughout theentire gown |
| Material Additives | Alcohol-Repellency to Front Bodyand Sleeves materials | Alcohol-Repellency throughoutthe entire gown. | Alcohol-Repellency throughoutthe entire gown. | |
| Anti-Static throughout the entiregown | Anti-Static throughout the entiregown | Anti-Static throughout the entiregown | ||
| Predicate Comparison | The material compositions aresame as the predicate. And thedifference in material additivesdoes not impact theperformance of AAMI PB70 andISO 10993-1 requirements, andtherefore is substantiallyequivalent to the predicate. | The predicate Kimberly-ClarkULTRA Film-Reinforced SurgicalGown meets the performancerequirements of AAMI PB70 andISO 10993-1 per K080795submission. | The Kimberly-Clark ULTRASurgical Gown meets theperformance requirements ofAAMI PB70 and ISO 10993-1 perK080795 submission. | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gown,code 954xx, 955xx(K080795) | Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) |
| Safety Properties | 16 CFR Part 1610(2014) Flammability | Tested and met Class 1requirement | Meets Class 1 requirement perK080795 submission | N/A |
| Biocompatibility | Testing was performedaccording to ISO 10993-5 andISO 10993-10. Under theconditions of each study, thedevice is non-cytotoxic, non-sensitizing and non-irritating. | Passed ISO 10993-1 per K080795submission | N/A | |
| Predicate Comparison | The ComfortGuard SurgicalGown, i600, Film Reinforced(i90-82xx-S1) is substantiallyequivalent to the predicate inbiocompatibility performance. | Predicate Kimberly-Clark ULTRAFilm-Reinforced Surgical Gownmeets ISO 10993-1 per K080795submission. | N/A |
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Technological Characteristics (cont.)
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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.
Safety Properties
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Liquid Barrier Performance Classification Properties- Critical Zones
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code 954xx,955xx(K080795) | Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) |
|---|---|---|---|---|
| Liquid Barrier Performance Classification Properties -Critical Zones | AAMI PB70 ASTM F1671-13Viral Penetration (Pass/Fail)Test ResultsPass/Fail(Results obtained from threeindependent Lots) | A1: Base Material: PASSA2: Tie Attachment: PASSB1: Lower Sleeve Seam: PASSB2: Upper Sleeve Seam: PASS | Meets ASTM F1671Requirements per K080795submission | N/A |
| AAMI PB70 ASTM F1671-13Viral Penetration (Pass/Fail)Level 4 Requirements | A1: Base Material: PassA2: Tie Attachment: PassB1: Lower Sleeve Seam: PassB2: Upper Sleeve Seam: PassAQL=4% ( $α=.05$ )RQL=20% ( $β=0.10$ )n=32; Acc=3; Rej=4 | Critical zone: PassCritical zone: PassCritical zone: PassCritical zone: PassN/AN/AN/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code 954xx,955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code951xx(K080795) |
| Liquid Barrier Performance Classification Properties- Non-Critical Zone(cont.) | ||||
| AATCC 42-2013 ImpactPenetration(grams)Test ResultsMean (Min, Max)(Results obtained from ThreeLots) | C1: Base Material:0.03grams (0.00, 0.08)C2: Sleeve Joint Sewn Seam:2.26grams (0.07, 4.42)C3: Sleeve Seam:0.00grams (0.00, 0.05) | N/A | N/A | |
| AAMI PB70 AATCC 42-2013Impact Penetration (grams)Level 1 Requirements | C1: Base Material: ≤4.5gC2: Sleeve Joint Sewn Seam:≤4.5gC3: Sleeve Seam: ≤4.5gAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | N/A | N/A | |
| Predicate Comparison | The ComfortGuard Surgical Gown,i600, Film Reinforced (i90-82xx-S1)meets PB70 level 1 requirements atNon-Critical Zones. | N/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code 954xx,955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code 951xx(K080795) |
| Liquid Barrier Performance Classification Properties- Non-CriticalZone (cont.) | AATCC 42-2013 ImpactPenetration(grams)Test ResultsMean (Min, Max)(Results obtained from ThreeLots) | D1: Back- Base Material:1.00grams (0.07, 4.31)D2: Back Joint Sewn Seam:2.54grams (0.21, 4.48)D3: Back Tie Attachment:0.89grams (0.00, 4.47) | N/A | N/A |
| AAMI PB70 AATCC 42-2013Impact Penetration (grams)Level 1 RequirementsPredicate Comparison | D1: Base Material: ≤4.5gD2: Back Joint Sewn Seam: ≤4.5gD3: Back Tie Attachment: ≤4.5gAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4The ComfortGuard SurgicalGown, i600, Film Reinforced(i90-82xx-S1) meets PB70 level 1requirements at Non-CriticalZones | N/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown,i600, Film Reinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code 954xx,955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code 951xx(K080795) |
| Physical Properties | ASTM D3776 (2009) BasisWeight(gsm)Test ResultsMean (Min, Max)(Results obtained from ThreeLots) | Critical zone - Body/SleeveMaterial:109.5gsm (103.0, 118.0)Non-Critical zone- Body/SleeveMaterial:49.3gsm (47.0, 52.0)Back Material:33.9gsm (32.0, 36.0) | N/A | N/A |
| ASTM D3776 (2009) BasisWeight (gsm)GRI Specifications | Critical zone - Body/SleeveMaterial:Mean =102gsm (-10, +10)Non-Critical zone- Body/SleeveMaterial:Mean =47gsm (-5, +5)Back Material:Mean =33gsm (-3, +3) | N/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown, i600, FilmReinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code 954xx,955xx (K080795) | Kimberly-Clark ULTRASurgical Gown, code951xx(K080795) |
| Physical Properties (cont.) | ASTM D5034-09 (2013)Grab Tensile(Newton)Test ResultMean (Min, Max)(Results obtained fromThree Lots) | Critical Zone Body/Sleeve Material MD:170.0N (151.6, 186.7)Critical Zone Body/Sleeve Material CD:141.5N (115.4, 166.8)Non-Critical Zone Body/Sleeve Material MD:95.9N (85.2, 107.9)Non-Critical Zone Body/Sleeve Material CD:61.3N (53.4, 70.9)Back Material MD:82.6N (62.5, 101.5)Back Material CD:56.7N (43.1, 67.2) | N/A | N/A |
| ASTM D5034-09 (2013)Grab Tensile (Newton)GRI Specifications | Critical Zone Body/Sleeve Material MD:Mean MD ≥ 100NCritical Zone Body/Sleeve Material CD:Mean CD ≥ 70NNon-Critical Zone Body/Sleeve Material MD:Mean MD ≥ 40NNon-Critical Zone Body/Sleeve Material CD:Mean CD ≥ 20NBack Material MD:Mean MD ≥ 40NBack Material CD:Mean CD ≥ 20N | N/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard Surgical Gown, i600, FilmReinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown code 954xx,955xx (K080795) | Kimberly-Clark ULTRASurgical Gown, code951xx(K080795) |
| Physical Properties (cont.) | ASTM D5587 (2014)Trapezoid Tear(Newton)Test ResultsMean (Min, Max)(Results obtained fromThree Lots) | Critical Zone Body/Sleeve Material MD:57.3N (42.8, 73.2) | N/A | N/A |
| Critical Zone Body/Sleeve Material CD:75.0N (62.1, 88.3) | ||||
| Non-Critical Zone Body/Sleeve Material MD:16.5N (13.2, 21.4) | ||||
| Non-Critical Zone Body/Sleeve Material CD:25.4N (20.9, 34.9) | ||||
| Back Material MD:20.7N (14.4, 28.4) | ||||
| Back Material CD:33.3N (24.9, 46.1) | ||||
| ASTM D5587 (2014)Trapezoid Tear (Newton)GRI Specifications | Critical Zone Body/Sleeve Material MD:Mean MD ≥ 20N | N/A | N/A | |
| Critical Zone Body/Sleeve Material CD:Mean CD ≥ 40N | ||||
| Non-Critical Zone Body/Sleeve Material MD:Mean MD ≥ 10N | ||||
| Non-Critical Zone Body/Sleeve Material CD:Mean CD ≥ 20N | ||||
| Back Material MD:Mean MD ≥ 10N | ||||
| Back Material CD:Mean CD ≥ 20N | ||||
| Element ofComparison | Device Description | ComfortGuard Surgical Gown, i600, FilmReinforced(i90-82xx-S1) | Predicate Kimberly-ClarkULTRA Film-ReinforcedSurgical Gown, code954xx, 955xx(K080795) | Kimberly-Clark ULTRASurgical Gown, code951xx(K080795) |
| Physical Properties (cont.) | ASTM D1683 (2007)Seam Strength(Newton)Test ResultsMean (Min, Max)(Results obtained fromThree Lots) | Outer Sleeve Seam:$47.4N$ (21.0, 60.2)Inner Sleeve Seam:$90.4N$ (75.2, 106.0) | N/A | N/A |
| ASTM D1683 (2007)Seam Strength (Newton)GRI Specifications | Outer Sleeve seam: Min ≥20 $N$Inner Sleeve seam: Min ≥50 $N$ | N/A | N/A | |
| Predicate Comparison | The ComfortGuard Surgical Gown, i600, FilmReinforced (i90-82xx-S1) meet thepredetermined specifications. | N/A | N/A |
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Liquid Barrier Performance Classification Properties- Non-Critical Zone Front and Sleeve (cont.)
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Liquid Barrier Performance Classification Properties- Back (cont.)
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Physical Properties
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Physical Properties (cont.)
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Physical Properties (cont.)
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Physical Properties (cont.)
1.2 Conclusion of the tests
Based on the results of the biocompatibility and physical performance testing, the GRI ComfortGuard Surgical Gown, i600, Film Reinforced is as safe and as effective, and as the predicate device for its indications for use. The ComfortGuard Surgical Gown, i600, Film Reinforced is substantially equivalent to 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.