(103 days)
ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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 ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.
Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks 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.
This document describes the acceptance criteria and the study that proves the device (ComfortGuard Plus Surgical Gown, i500 and ComfortGuard Surgical Gown, i500) meets these criteria.
Acceptance Criteria and Device Performance
The acceptance criteria for the surgical gowns are based on their performance as protective apparel, specifically their liquid barrier performance (AAMI PB70 standard) and other physical and safety properties.
Table 1: Acceptance Criteria and Reported Device Performance
| Element of Comparison | Acceptance Criteria (per AAMI PB70, ISO 10993, ASTM, 16 CFR) | ComfortGuard Plus Surgical Gown, i500 (Reported Performance - Mean) | ComfortGuard Surgical Gown, i500 (Reported Performance - Mean) |
|---|---|---|---|
| General | |||
| AAMI PB 70 Classification | Level 3 | Level 3 | Level 3 |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Safety Properties | |||
| 16 CFR Part 1610 (2014) Flammability | Class 1 requirement | Met Class 1 requirement | Met Class 1 requirement |
| Biocompatibility (ISO 10993-5, 10993-10) | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating |
| Liquid Barrier Performance - Critical Zones | |||
| AATCC 127-2014 Hydrostatic Pressure (mmH2O) | A1: Base Material: ≥500mmH2OA2: Tie Attachment: ≥500mmH2OB1: Sleeve Seam: ≥500mmH2O | A1: Base Material: 657mmH2OA2: Tie Attachment: 668mmH2OB1: Sleeve Seam: 760mmH2O | A1: Base Material: 749mmH2OA2: Tie Attachment: 637mmH2OB1: Sleeve Seam: 689mmH2O |
| AATCC 42-2013 Impact Penetration (grams) | A1: Base Material: ≤1.0gA2: Tie Attachment: ≤1.0gB1: Sleeve Seam: ≤1.0g | A1: Base Material: 0.04gA2: Tie Attachment: 0.02gB1: Sleeve Seam: 0.04g | A1: Base Material: 0.07gA2: Tie Attachment: 0.01gB1: Sleeve Seam: 0.06g |
| Liquid Barrier Performance - Non-Critical Zones | |||
| AATCC 42-2013 Impact Penetration (grams) | C1: Base Material: ≤4.5gC2: Sleeve Joint Sewn Seam: ≤4.5gC3: Sleeve Seam: ≤4.5g | C1: Base Material: 0.02gC2: Sleeve Joint Sewn Seam: 0.25gC3: Sleeve Seam: 0.06g | C1: Base Material: 0.03gC2: Sleeve Joint Sewn Seam: 0.29gC3: Sleeve Seam: 0.03g |
| AATCC 42-2013 Impact Penetration (grams) | D1: Back- Base Material: ≤4.5gD2: Back Joint Sewn Seam: ≤4.5gD3: Back Tie Attachment: ≤4.5g | D1: Back- Base Material: 0.17gD2: Back Joint Sewn Seam: 1.56gD3: Back Tie Attachment: 0.86g | D1: Back- Base Material: 0.27gD2: Back Joint Sewn Seam: 1.93gD3: Back Tie Attachment: 0.65g |
| Physical Properties | |||
| ASTM D3776 (2009) Basis Weight (gsm) | Body/Sleeve Material: Mean=43gsm (-2, +6)Back Material: Mean=33gsm (-2, +6) | Body/Sleeve Material: 46gsmBack Material: 34gsm | Body/Sleeve Material: 50gsmBack Material: 33gsm |
| ASTM D5034-09 (2013) Grab Tensile (Newton) | Body/Sleeve Material: Mean MD ≥50N, Mean CD ≥30NBack Material: Mean MD ≥40N, Mean CD ≥20N | Body/Sleeve Material MD: 82.84NBody/Sleeve Material CD: 58.54NBack Material MD: 89.52NBack Material CD: 56.32N | Body/Sleeve Material MD: 98.93NBody/Sleeve Material CD: 61.34NBack Material MD: 83.87NBack Material CD: 56.16N |
| ASTM D5587 (2014) Trapezoid Tear (Newton) | Body/Sleeve Material: Mean MD ≥10N, Mean CD ≥20NBack Material: Mean MD ≥10N, Mean CD ≥20N | Body/Sleeve Material: 19.01NBody/Sleeve Material CD: 28.14NBack Material MD: 21.19NBack Material CD: 37.00N | Body/Sleeve Material MD: 15.69NBody/Sleeve Material CD: 25.40NBack Material MD: 20.74NBack Material CD: 35.49N |
| ASTM D1683 (2007) Seam Strength (Newton) | Sleeve seam: Mean ≥15N | Sleeve Seam: 38.80N | Sleeve Seam: 49.01N |
Note on Reported Performance: The reported device performance values are the "Mean" results obtained from three lots, as provided in the tables within the document. The values in parenthesis (Min, Max) represent the range of results obtained. The document states that both devices "meet the predetermined specifications" for these physical properties.
Study Proving Device Meets Acceptance Criteria
The provided document is a 510(k) Pre-market Notification for surgical gowns, demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the comprehensive testing conducted to prove that the new devices meet established performance standards (acceptance criteria) and are as safe and effective as a legally marketed predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
(See Table 1 above)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the AATCC and ASTM tests (Hydrostatic Pressure, Impact Penetration, Grab Tensile, Trapezoid Tear, Seam Strength), the acceptance criteria specify a sample size of n=32 (Acc=3; Rej=4) for the AQL/RQL statistical sampling plan. The test results reported were "obtained from Three Lots".
- Data Provenance: The document does not explicitly state the country of origin where the testing was performed. The applicant, GRI Medical & Electrical Technology Co., Ltd., is located in China, suggesting the data may originate from testing facilities in China or a contracted lab. The data is retrospective, as it represents results from tests already performed to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of submission for surgical apparel does not involve clinical studies with human "experts" establishing ground truth in the way a diagnostic AI device would. The "ground truth" for the performance of these surgical gowns is established by adherence to recognized industry standards (AAMI PB70, ASTM, 16 CFR, ISO) and laboratory testing methodologies described within those standards. The expertise lies in the certified labs and technicians performing these specific material and barrier tests. There is no mention of "experts" in the context of clinical interpretation or adjudication.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Performance is measured against objective, quantitative physical and barrier properties according to established industry standards, not subjective expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI-assisted ones, where human readers interpret medical images. Surgical gowns are physical barrier devices, and their effectiveness is determined by laboratory performance testing, not human reading of cases. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical gown), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" is defined by the objective, quantitative performance requirements of the referenced industry standards:
- AAMI PB70: Liquid barrier performance and classification for protective apparel.
- 16 CFR Part 1610: Flammability standards.
- ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation & Sensitization): Biocompatibility standards.
- ASTM D3776, D5034-09, D5587, D1683: Physical property testing standards (basis weight, tensile strength, tear resistance, seam strength).
- AATCC 127-2014 & AATCC 42-2013: Hydrostatic pressure and impact penetration for liquid barrier.
These standards provide the pre-defined, objectively measurable criteria for performance.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this device would refer to the manufacturing processes and quality control to consistently produce gowns meeting the specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI. For the manufacturing process, the "ground truth" (or target specifications) for quality control and process validation would be established by the engineering and quality teams based on material properties, design requirements, and the performance criteria outlined in the regulatory standards (e.g., AAMI PB70 Level 3).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2016
GRI Medical & Electrical Technology Co., Ltd. % Harry Shaffer President Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, Colorado 80129
Re: K162442
Trade/Device Name: ComfortGuard Plus Surgical Gown, i500 ComfortGuard Surgical Gown, i500 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 4, 2016 Received: November 7, 2016
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 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
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the quality systems (OS) 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.
Michael J. 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) K162442
Device Name
ComfortGuard Surgical Gown, i500
Indications for Use (Describe)
ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Confidential
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Global Resources International
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
Indications for Use
510(k) Number (if known) K162442
Device Name
ComfortGuard Plus Surgical Gown, i500
Indications for Use (Describe)
ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 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.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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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: | December 7th, 2016 |
|---|---|
| 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 Plus Surgical Gown, i500ComfortGuard Surgical Gown, i500 |
| 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 Surgical Gown (K080795) |
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Description of the Device 1.1
The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.
Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.
Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks 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
ComfortGuard Plus Surgical Gown, i500
ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
ComfortGuard Surgical Gown, i500
ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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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Table C-1 Product List
| Product List | ||
|---|---|---|
| Product Name | Model Code withoutThumb-hooks | Model Code withThumb-hooks |
| ComfortGuard Plus Surgical Gown, i500 | i90-70xx-S1 | i90-70xxT-S1 |
| i90-70xx | i90-70xxT | |
| ComfortGuard Surgical Gown, i500 | i90-80xx-S1 | i90-80xxT-S1 |
| i90-80xx | i90-80xxT |
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 front "fabric"7 = Soft SMS8 = 47gsm SMS |
| Suffix - 2 | Second position represents "reinforcement"0 = None |
| Suffix - 3(x) | Third position represents "size"0 = Small1 = Medium2 = Large3 = XL4 = XXL |
| Suffix - 4(x) | Fourth position represents "length"0 = Standard2 = XLong |
| Suffix - 5 | Fifth position represents "Thumb-hooks"T = with thumb-hooks |
| Suffix - 6 | Sixth position represents "packaging"S1 = Sterile |
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1.3 Product Codes covered in this submission
Table C-3- Product Catalog Number and Description
| Catalog # | Model Description | Size | |||
|---|---|---|---|---|---|
| Sterile | Non-Sterile | ||||
| Without Thumb-hook | With Thumb-hook | Without Thumb-hook | With Thumb-hook | ||
| i90-7000-S1 | i90-7000T-S1 | i90-7000 | i90-7000T | ComfortGuard Plus Surgical Gown, i500 | S |
| i90-7010-S1 | i90-7010T-S1 | i90-7010 | i90-7010T | ComfortGuard Plus Surgical Gown, i500 | M |
| i90-7020-S1 | i90-7020T-S1 | i90-7020 | i90-7020T | ComfortGuard Plus Surgical Gown, i500 | L |
| i90-7030-S1 | i90-7030T-S1 | i90-7030 | i90-7030T | ComfortGuard Plus Surgical Gown, i500 | XL |
| i90-7040-S1 | i90-7040T-S1 | i90-7040 | i90-7040T | ComfortGuard Plus Surgical Gown, i500 | XXL |
| i90-7022-S1 | i90-7022T-S1 | i90-7022 | i90-7022T | ComfortGuard Plus Surgical Gown, i500 | L-XLONG |
| i90-7032-S1 | i90-7032T-S1 | i90-7032 | i90-7032T | ComfortGuard Plus Surgical Gown, i500 | XL-XLONG |
| i90-7042-S1 | i90-7042T-S1 | i90-7042 | i90-7042T | ComfortGuard Plus Surgical Gown, i500 | XXL-XLONG |
| i90-8000-S1 | i90-8000T-S1 | i90-8000 | i90-8000T | ComfortGuard Surgical Gown, i500 | S |
| i90-8010-S1 | i90-8010T-S1 | i90-8010 | i90-8010T | ComfortGuard Surgical Gown, i500 | M |
| i90-8020-S1 | i90-8020T-S1 | i90-8020 | i90-8020T | ComfortGuard Surgical Gown, i500 | L |
| i90-8030-S1 | i90-8030T-S1 | i90-8030 | i90-8030T | ComfortGuard Surgical Gown, i500 | XL |
| i90-8040-S1 | i90-8040T-S1 | i90-8040 | i90-8040T | ComfortGuard Surgical Gown, i500 | XXL |
| i90-8022-S1 | i90-8022T-S1 | i90-8022 | i90-8022T | ComfortGuard Surgical Gown, i500 | L-XLONG |
| i90-8032-S1 | i90-8032T-S1 | i90-8032 | i90-8032T | ComfortGuard Surgical Gown, i500 | XL-XLONG |
| i90-8042-S1 | i90-8042T-S1 | i90-8042 | i90-8042T | ComfortGuard Surgical Gown, i500 | XXL-XLONG |
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1.4 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 | DeviceDescription | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
|---|---|---|---|---|---|
| General | Manufacturer | GRI | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. |
| Product TradeName | ComfortGuard PlusSurgical Gown, i500 | ComfortGuard SurgicalGown, i500 | ULTRA Surgical Gown | ULTRA Film-ReinforcedSurgical Gown | |
| Classification # | Class II, 21 CFR 878.4040 | 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 | Surgical Apparel | |
| Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | |
| AAMI PB 70Classification | Level 3 | Level 3 | Level 3 | Level 4 | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| PredicateComparison | Subject device issubstantially equivalent tothe predicate inclassification andsterilization method. | Subject device issubstantially equivalent tothe predicate inclassification andsterilization method. | Predicate- This Device is aLevel 3 non-reinforcedsurgical gown per K080795submission, and is used asthe predicate. The subjectdevices are substantiallyequivalent to this gown fortheir intended use. | This device is a level 4Film-Reinforced surgicalgown per K080795submission. Subjectdevices are notsubstantially equivalent tothis gown. This gown is notconsidered as a predicate. | |
| Element ofComparison | DeviceDescription | ComfortGuard Plus SurgicalGown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown, code951xx(K080795) | Kimberly-Clark ULTRA Film-Reinforced Surgical Gown,code 954xx, 955xx(K080795) |
| Indications for Use | Indications for Use | ComfortGuard Plus SurgicalGown, i500 are single usesurgical gowns intended toprotect surgical patientsand operating roompersonnel from the transferof microorganisms, bodyfluids, and particulatematerial.ComfortGuard Plus SurgicalGown, i500 have been testedand are classified as Level 3in the critical zones per AAMIStandard PB70 Liquid barrierperformance andclassification of protectiveapparel and drapes intendedfor use in healthcarefacilities. | ComfortGuard SurgicalGown, i500 are single usesurgical gowns intended toprotect surgical patientsand operating roompersonnel from the transferof microorganisms, bodyfluids, and particulatematerial.ComfortGuard SurgicalGown, i500 have been testedand are classified as Level 3in the critical zones per AAMIStandard PB70 Liquid barrierperformance andclassification of protectiveapparel and drapes intendedfor use in healthcarefacilities. | The Kimberly-Clark ULTRASurgical Gowns and ULTRAFilm-Reinforced SurgicalGowns are sterile, single usesurgical gown intended toprotect both the surgicalpatient and the operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematerial.The ULTRA Surgical Gownsmeet Level 3 of the AAMILiquid Barrier classifications,and the ULTRA Film-Reinforced Surgical Gownsmeet Level 4 of the AAMILiquid Barrier classifications. | The Kimberly-Clark ULTRASurgical Gowns and ULTRAFilm-Reinforced SurgicalGowns are sterile, single usesurgical gown intended toprotect both the surgicalpatient and the operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematerial.The ULTRA Surgical Gownsmeet Level 3 of the AAMILiquid Barrier classifications,and the ULTRA Film-Reinforced Surgical Gownsmeet Level 4 of the AAMILiquid Barrier classifications. |
| PredicateComparison | Subject device is substantiallyequivalent to the predicate inits indications for use. Thesubject device and predicateare Level 3 surgical gowns. | Subject device is substantiallyequivalent to the predicate inits indications for use. Thesubject device and predicateare Level 3 surgical gowns. | Predicate- This Device is aLevel 3 non-reinforcedsurgical gown per K080795submission, and is used asthe predicate. | This device is a level 4 Film-Reinforced surgical gown perK080795 submission. Subjectdevices are not substantiallyequivalent to this gown. Thisgown is not considered as apredicate | |
| Element ofComparison | DeviceDescription | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
| Technological Characteristics | DeviceDescription | The ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) is comprised of asingle layer of polyolefinnonwoven SMS fabricthroughout the entiregown, with no additionalreinforcement. | The ComfortGuardSurgical Gown, i500 (i90-80xx-S1) is comprised of asingle layer of polyolefinnonwoven SMS fabricthroughout the entiregown, with no additionalreinforcement. | Predicate Kimberly-ClarkULTRA Gown is a full-length, nonwoven SMSpolypropylene gown. | Kimberly-Clark ULTRAFilm-Reinforced Gown is afull-length, nonwovenSMS polypropylene gown.The ULTRA Film-Reinforced Surgical Gownis film-reinforced forhigher barrier protection. |
| The ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) is provided withneck binder, hook andloop tabs, belt ties,removable transferaccessory, and cuffs. | The ComfortGuardSurgical Gown, i500 (i90-80xx-S1) is provided withneck binder with hookand loop tabs, belt ties,removable transferaccessory, and cuffs. | Predicate Kimberly-ClarkULTRA Gown isconstructed with raglansleeves, hook-and-loopneck closures, and tiewaist closures. | Kimberly-Clark ULTRAFilm-Reinforced Gown isconstructed with raglansleeves, hook-and-loopneck closures, and tiewaist closures. | ||
| Elementof | DeviceDescription | ComfortGuard Plus SurgicalGown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
| Technological Characteristics (cont.) | The ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) is constructed withor without thumb-hooks incuffs. | The ComfortGuard SurgicalGown, i500 (i90-80xx-S1)constructed with or withoutthumb-hooks in cuffs. | The predicate does nothave thumb-hooks incuffs. | Kimberly-Clark ULTRAFilm-Reinforced Gowndoes not have thumb-hooks in cuffs. | |
| DesignDifferences | The ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) is constructed withpleats in the back panels. | The ComfortGuard SurgicalGown, i500 (i90-80xx-S1)constructed with pleats inthe back panels. | The predicate is notconstructed with pleats inthe back. | Kimberly-Clark ULTRAFilm-Reinforced Gown isnot constructed withpleats in the back. | |
| The ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) is constructed witha lower basis weight SMS inthe back panels. | The ComfortGuard SurgicalGown, i500 (i90-80xx-S1) isconstructed with a lowerbasis weight SMS in the backpanels. | The predicate utilizes thesame basis weight SMSthroughout the entiregown. | Kimberly-Clark ULTRAFilm-Reinforced Gown iscomprised of multiplematerials and is notconsidered as a predicate. | ||
| PredicateComparison | The addition of thumb-hooks,back pleats, and the use of alighter basis weight materialin the back panels does notimpact the performance ofthe gown in accordance withAAMI PB70 requirement, andtherefore is substantiallyequivalent to the predicate. | The addition of thumb-hooks, back pleats, and theuse of a lighter basis weightmaterial in the back panelsdoes not impact theperformance of the gown inaccordance with AAMI PB70requirement, and thereforeis substantially equivalent tothe predicate. | The predicate Kimberly-Clark Ultra Surgical Gowndoes not include theseDesign features | The predicate Kimberly-Clark Ultra Film-Reinforced Surgical Gowndoes not include theseDesign features | |
| Element ofComparison | DeviceDescription | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
| Technological Characteristics (cont.) | MaterialComposition | Single layer of Soft SMS(polyolefin nonwoven) inthe front and sleeve,single layer of SMS(Polyolefin nonwoven) inthe back panels with alower basis weight SMS | Single layer of SMS(polyolefin nonwoven) inthe front and sleeve,single layer of SMS(Polyolefin nonwoven) inthe back panels with alower basis weight SMS | Single Layer of SMS(polyolefin nonwoven)throughout the entiregown | Multi-layer construction(SMS & Film lamination)in the entire front bodyand sleeve, single layer ofSMS (polyolefinnonwoven) in back panels |
| MaterialAdditives | Alcohol-Repellency toFront Body and SleevesmaterialAnti-Static throughout | Alcohol-Repellency toFront Body and SleevesmaterialAnti-Static throughout | Alcohol-Repellencythroughout the entiregown.Anti-Static throughout | Alcohol-Repellencythroughout the entiregown.Anti-Static throughout | |
| the entire gownSoftness treatment toBody and Sleevesmaterial | the entire gownNo softness treatment | the entire gownN/A | the entire gownN/A | ||
| PredicateComparison | The material additives donot impact theperformance of the gownin accordance with AAMIPB70 and ISO 10993-1requirements, andtherefore is substantiallyequivalent to thepredicate. | The material additives donot impact theperformance of the gownin accordance with AAMIPB70 and ISO 10993-1requirements, andtherefore is substantiallyequivalent to thepredicate. | The predicate Kimberly-Clark Ultra Surgical Gownmeets the performancerequirements of AAMIPB70 and ISO 10993-1 perK080795 submission. | The Kimberly-Clark UltraFilm-Reinforced SurgicalGown meets theperformancerequirements of AAMIPB70 and ISO 10993-1 perK080795 submission. | |
| Element ofComparison | DeviceDescription | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
| Safety Properties | 16 CFR Part 1610(2014)Flammability | Tested and met Class 1requirement | Tested and met Class 1requirement | Meets Class 1requirement per K080795submission | N/A |
| Biocompatibility | Testing was performedaccording to ISO 10993-5and ISO 10993-10. Underthe conditions of eachstudy, the device is non-cytotoxic, non-sensitizingand non-irritating. | Testing was performedaccording to ISO 10993-5and ISO 10993-10. Underthe conditions of eachstudy, the device is non-cytotoxic, non-sensitizingand non-irritating. | Passed ISO 10993-1 perK080795 submission | N/A | |
| PredicateComparison | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) issubstantially equivalentto the predicate inbiocompatibilityperformance. | ComfortGuard SurgicalGown, i500(i90-80xx-S1) issubstantially equivalentto the predicate inbiocompatibilityperformance. | Kimberly-Clark ULTRASurgical Gown meets ISO10993-1 per K080795submission. | N/A | |
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
| Liquid Barrier Performance Classification Properties – CriticalZones | AATCC 127-2014Hydrostatic Pressure(mmH2O)Test ResultsMean (Min, Max)(Results obtainedfrom Three Lots) | A1: Base Material:657mmH2O (548, 796)A2: Tie Attachment:668mmH2O (572, 756)B1: Sleeve Seam:760mmH2O (635, 864) | A1: Base Material:749mmH2O (625, 825)A2: Tie Attachment:637mmH2O (560, 706)B1: Sleeve Seam:689mmH2O (576, 805) | Meets AATCC 127Requirements perK080795 submission | N/A |
| AAMI PB70 AATCC127-2014 HydrostaticPressure (mmH2O)Requirements | A1: Base Material:≥500mmH2OA2: Tie Attachment:≥500mmH2OB1: Sleeve Seam:≥500mmH2O | A1: Base Material:≥500mmH2OA2: Tie Attachment:≥500mmH2OB1: Sleeve Seam:≥500mmH2O | Front Body: ≥500mmH2OFront Body: ≥500mmH2OSleeve Seam:≥500mmH2O | ||
| AQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | AQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | N/AN/AN/A | |||
| Element of Comparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-Clark ULTRA SurgicalGown , code 951xx(K080795) | Kimberly-Clark ULTRAFilm-ReinforcedSurgical Gown, code954xx, 955xx(K080795) |
| Liquid Barrier Performance Classification Properties – Critical Zones (cont.) | AATCC 42-2013Impact Penetration(grams)Test ResultsMean (Min, Max)(Results obtainedfrom Three Lots) | A1: Base Material:0.04g (0.01, 0.06)A2: Tie Attachment:0.02g (0.00, 0.10)B1: Sleeve Seam:0.04g (0.02, 0.09) | A1: Base Material:0.07g (0.03, 0.16)A2: Tie Attachment:0.01g (0.00, 0.07)B1: Sleeve Seam:0.06g (0.03, 0.09) | Meets AATCC 42Requirements perK080795 submission | N/A |
| AAMI PB70 AATCC42-2013 ImpactPenetration (grams)Requirements | A1: Base Material: ≤1.0gA2: Tie Attachment: ≤1.0gB1: Sleeve Seam: ≤1.0g | A1: Base Material: ≤1.0gA2: Tie Attachment ≤1.0gB1: Sleeve Seam: ≤1.0g | Front Body: ≤1.0gFront Body: ≤1.0gSleeve Seam: ≤1.0g | ||
| AQL=4% (α=.05) | AQL=4% (α=.05) | N/A | |||
| RQL=20% (β=0.10) | RQL=20% (β=0.10) | N/A | |||
| n=32; Acc=3; Rej=4 | n=32; Acc=3; Rej=4 | N/A | |||
| PredicateComparison | The GRI ComfortGuard PlusSurgical Gown, i500 (i90-70xx-S1) meets PB70 level3 requirements at CriticalZones and therefore issubstantially equivalent tothe predicate. | The GRI ComfortGuardSurgical Gown, i500 (i90-80xx-S1) meets PB70 level3 requirements at CriticalZones and therefore issubstantially equivalent tothe predicate. | The Predicate DeviceKimberly-Clark UltraSurgical Gown meetsPB70 level 3requirements perK080795 submission. | ||
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) | Kimberly-Clark ULTRAFilm-ReinforcedSurgical Gown, code954xx, 955xx(K080795) |
| - Liquid Barrier Performance Classification Properties- Non-Critical Zone(cont.) | AATCC 42-2013 ImpactPenetration(grams)Test ResultsMean (Min, Max)(Results obtained fromThree Lots) | C1: Base Material:0.02g (0.00, 0.11)C2: Sleeve Joint SewnSeam:0.25g (0.00,1.71)C3: Sleeve Seam:0.06g (0.00, 0.48) | C1: Base Material:0.03g (0.00, 0.08)C2: Sleeve Joint SewnSeam:0.29g (0.00, 2.68)C3: Sleeve Seam:0.03g (0.00, 0.09) | N/A | |
| AAMI PB70 AATCC 42-2013 ImpactPenetration (grams)Requirements | C1: Base Material: ≤4.5gC2: Sleeve Joint SewnSeam:≤4.5gC3: Sleeve Seam: ≤4.5gAQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | C1: Base Material: ≤4.5gC2: Sleeve Joint SewnSeam:≤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 GRI ComfortGuardPlus Surgical Gown,i500 (i90-70xx-S1)meets PB70 level 1requirements at Non-Critical Zones. | The GRI ComfortGuardSurgical Gown, i500(i90-80xx-S1) meetsPB70 level 1requirements at Non-Critical Zones. | N/A | N/A | |
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) | Kimberly-Clark ULTRAFilm-ReinforcedSurgical Gown, code954xx, 955xx(K080795) |
| Liquid Barrier Performance Classification Properties- Non-Critical Zone(cont.) | AATCC 42-2013Impact Penetration(grams) | D1: Back- Base Material:0.17g (0.04, 0.33) | D1: Back- Base Material:0.27g (0.07, 0.72) | N/A | N/A |
| Test ResultsMean (Min, Max) | D2: Back Joint Sewn Seam:1.56g (0.03, 4.03) | D2: Back Joint Sewn Seam:1.93g (0.30, 4.16) | |||
| (Results obtainedfrom Three Lots) | D3: Back Tie Attachment:0.86g (0.04, 3.99) | D3: Back Tie Attachment:0.65g (0.06, 3.84) | |||
| AAMI PB70 AATCC42-2013 ImpactPenetration (grams)Requirements | D1: Base Material: ≤4.5g | D1: Base Material: ≤4.5g | |||
| D2: Back Joint Sewn Seam: ≤4.5g | D2: Back Joint Sewn Seam: ≤4.5g | ||||
| D3: Back Tie Attachment: ≤4.5g | D3: Back Tie Attachment: ≤4.5g | ||||
| AQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | AQL=4% (α=.05)RQL=20% (β=0.10)n=32; Acc=3; Rej=4 | ||||
| PredicateComparison | The GRI ComfortGuardPlus Surgical Gown, i500(i90-70xx-S1) meets PB70level 1 requirements atNon-Critical Zones | The GRI ComfortGuardSurgical Gown, i500 (i90-80xx-S1) meets PB70 level1 requirements at Non-Critical Zones | |||
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-Clark ULTRA SurgicalGown, code 951xx(K080795) | Kimberly-Clark ULTRAFilm-ReinforcedSurgical Gown, code954xx, 955xx(K080795) |
| Physical Properties | ASTM D3776 (2009)Basis Weight(gsm)Test ResultsMean (Min, Max)(Results obtained fromThree Lots) | Body/Sleeve Material:46gsm (44, 47) | Body/Sleeve Material:50gsm (47, 52) | N/A | N/A |
| Back Material:34gsm (31, 35) | Back Material:33gsm (32, 35) | ||||
| ASTM D3776 (2009)Basis Weight (gsm)GRI Specifications | Body/Sleeve Material:Mean=43gsm (-2, +6) | Body/Sleeve Material:Mean=47gsm (-2, +6) | N/A | N/A | |
| Back Material:Mean=33gsm (-2, +6) | Back Material:Mean=33gsm (-2, +6) |
{9}------------------------------------------------
Indications for Use
{10}------------------------------------------------
Technological Characteristics
{11}------------------------------------------------
Technological Characteristics (cont.)
{12}------------------------------------------------
Technological Characteristics (cont.)
{13}------------------------------------------------
Safety Properties
{14}------------------------------------------------
Liquid Barrier Performance Classification Properties- Critical Zones
{15}------------------------------------------------
Liquid Barrier Performance Classification Properties- Critical Zones (cont.)
{16}------------------------------------------------
Liquid Barrier Performance Classification Properties- Non-Critical Zone Front and Sleeve (cont.)
{17}------------------------------------------------
Liquid Barrier Performance Classification Properties- Non-Critical Zone Back (cont.)
{18}------------------------------------------------
Physical Properties
{19}------------------------------------------------
Physical Properties (cont.)
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-Clark ULTRA SurgicalGown , code 951xx(K080795) | Kimberly-Clark ULTRAFilm-ReinforcedSurgical Gown, code954xx, 955xx(K080795) |
|---|---|---|---|---|---|
| Physical Properties (cont.) | ASTM D5034-09 (2013)Grab Tensile(Newton)Test ResultMean (Min, Max)(Results obtained fromThree Lots) | Body/Sleeve MaterialMD:82.84N (70.28, 92.31)Body/Sleeve MaterialCD:58.54N (49.24, 64.48)Back Material MD:89.52N (75.43, 103.93)Back Material CD:56.32N (47.31, 65.63) | Body/Sleeve MaterialMD:98.93N (88.17, 108.44)Body/Sleeve MaterialCD:61.34N (54.26, 69.80)Back Material MD:83.87N (68.05, 96.05)Back Material CD:56.16N (45.65, 66.43) | N/A | N/A |
| ASTM D5034-09 (2013)Grab Tensile (Newton)GRI Specifications | Body/Sleeve Material:Mean MD ≥50NBody/Sleeve Material:Mean CD ≥30NBack Material:Mean MD ≥40NBack Material:Mean CD ≥20NPASS/FAIL | Body/Sleeve Material:Mean MD ≥50NBody/Sleeve Material:Mean CD ≥30NBack Material:Mean MD ≥40NBack Material:Mean CD ≥20NPASS/FAIL | N/A | N/A |
{20}------------------------------------------------
Physical Properties (cont.)
| Element ofComparison | DeviceDescription | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
|---|---|---|---|---|---|
| Physical Properties (cont.) | ASTM D5587(2014) TrapezoidTear | Body/Sleeve Material:19.01N (15.46,22.85) | Body/Sleeve MaterialMD:15.69N (13.24, 19.04) | ||
| (Newton)Test Results | Body/Sleeve Material CD:28.14N (24.33, 32.39) | Body/Sleeve Material CD:25.40N (21.47, 30.65) | N/A | N/A | |
| Mean (Min, Max)(Results obtainedfrom Three Lots) | Back Material MD:21.19N (16.94, 28.26) | Back Material MD:20.74N (15.34, 28.05) | |||
| Back Material CD:37.00N (30.30, 47.08) | Back Material CD:35.49N (29.12, 46.19) | ||||
| ASTM D5587(2014) TrapezoidTear (Newton)GRI Specifications | Body/Sleeve Material:Mean MD ≥10N | Body/Sleeve Material:Mean MD ≥10N | N/A | N/A | |
| Body/Sleeve Material:Mean CD ≥20N | Body/Sleeve Material:Mean CD ≥20N | ||||
| Back Material:Mean MD ≥10N | Back Material:Mean MD ≥10N | ||||
| Back Material:Mean CD ≥20N | Back Material:Mean CD ≥20N | N/A | N/A | ||
| PASS/FAIL | PASS/FAIL | N/A |
{21}------------------------------------------------
Physical Properties (cont.)
| Element ofComparison | Device Description | ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) | ComfortGuard SurgicalGown, i500(i90-80xx-S1) | Predicate Kimberly-ClarkULTRA Surgical Gown ,code 951xx(K080795) | Kimberly-Clark ULTRAFilm-Reinforced SurgicalGown, code 954xx, 955xx(K080795) |
|---|---|---|---|---|---|
| Physical Properties (cont.) | ASTM D1683 (2007)Seam Strength(Newton)Test ResultsMean (Min, Max)(Results obtainedfrom Three Lots) | Sleeve Seam:38.80N (27.88, 48.77) | Sleeve Seam:49.01N (28.10, 63.29) | N/A | N/A |
| ASTM D1683 (2007)Seam Strength(Newton)GRI Specifications | Sleeve seam: Mean≥15NPASS/FAIL | Sleeve seam: Mean ≥15NPASS/FAIL | N/A | N/A | |
| PredicateComparison | The ComfortGuard PlusSurgical Gown, i500(i90-70xx-S1) meet thepredeterminedspecifications. | The ComfortGuardSurgical Gown, i500 (i90-80xx-S1) meet thepredeterminedspecifications. | N/A | N/A |
1:5 Conclusion of the tests
Based on the results of the biocompatibility and physical performance testing, the GRI Surgical Gowns are as safe and as performs as well as the predicate device for their intended use. The GRI Surgical Gowns are 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.