ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
Device Facts
| Record ID | K162442 |
|---|---|
| Device Name | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 |
| Applicant | Gri Medical & Electrical Technology Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Dec 12, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Single-use surgical gowns; constructed from polyolefin nonwoven SMS fabric; available in sterile and non-sterile configurations. Features include neck binders, hook-and-loop tabs, belt ties, removable transfer accessories, and cuffs (optional thumb-hooks). Designed for use in operating rooms by surgical personnel. Provides barrier protection against microorganisms, body fluids, and particulates. Performance validated against AAMI PB70 Level 3 requirements. Protects both patient and staff during surgical procedures.
Clinical Evidence
Bench testing only. Performance evaluated per AAMI PB70:2012. Testing included hydrostatic pressure (AATCC 127-2014), impact penetration (AATCC 42-2013), flammability (16 CFR 1610), basis weight (ASTM D3776), grab tensile strength (ASTM D5034), trapezoid tear (ASTM D5587), and seam strength (ASTM D1683). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation). All results met predetermined specifications.
Technological Characteristics
Materials: Polyolefin nonwoven SMS fabric. Construction: Single layer, no reinforcement. Energy: None. Connectivity: None. Sterilization: Ethylene Oxide. Standards: AAMI PB70 (Level 3), ASTM D3776, ASTM D5034, ASTM D5587, ASTM D1683, ISO 10993-5, ISO 10993-10, 16 CFR 1610.
Indications for Use
Indicated for use as single-use surgical gowns to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Classified as AAMI Level 3 for critical zones.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- Kimberly-Clark ULTRA Surgical Gown (K080795)
Submission Summary (Full Text)
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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.
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> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (8/14)
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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/QA<br>1805 HongGao Road<br>XiuZhou Industry Zone<br>JiaXing, ZheJiang, China, 314031<br>Tel: 86-135-1135-9722<br>Email: mpaugh@gri-china.com |
| Official Correspondent: | Harry Shaffer, President<br>Sterilization Consulting Services LLC<br>10051 Oak Leaf way, Highlands Ranch, CO 80129<br>Tel: 303-929-3808<br>Email: HShaffer@Sterilizationconsulting.com |
| Device Trade Name: | ComfortGuard Plus Surgical Gown, i500<br>ComfortGuard Surgical Gown, i500 |
| Common or Usual Name: | Surgical gown |
| Classification Name: | Surgical Apparel |
| Device Classification: | Class II per 21 CFR §878.4040<br>General and plastic surgery<br>Product Code: FYA |
| Predicate Device: | 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 without<br>Thumb-hooks | Model Code with<br>Thumb-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"<br>7 = Soft SMS<br>8 = 47gsm SMS |
| Suffix - 2 | Second position represents "reinforcement"<br>0 = None |
| Suffix - 3(x) | Third position represents "size"<br>0 = Small<br>1 = Medium<br>2 = Large<br>3 = XL<br>4 = XXL |
| Suffix - 4(x) | Fourth position represents "length"<br>0 = Standard<br>2 = XLong |
| Suffix - 5 | Fifth position represents "Thumb-hooks"<br>T = with thumb-hooks |
| Suffix - 6 | Sixth position represents "packaging"<br>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-<br>S1 | i90-7000T-<br>S1 | i90-7000 | i90-7000T | ComfortGuard Plus Surgical Gown, i500 | S |
| i90-7010-<br>S1 | i90-7010T-<br>S1 | i90-7010 | i90-7010T | ComfortGuard Plus Surgical Gown, i500 | M |
| i90-7020-<br>S1 | i90-7020T-<br>S1 | i90-7020 | i90-7020T | ComfortGuard Plus Surgical Gown, i500 | L |
| i90-7030-<br>S1 | i90-7030T-<br>S1 | i90-7030 | i90-7030T | ComfortGuard Plus Surgical Gown, i500 | XL |
| i90-7040-<br>S1 | i90-7040T-<br>S1 | i90-7040 | i90-7040T | ComfortGuard Plus Surgical Gown, i500 | XXL |
| i90-7022-<br>S1 | i90-7022T-<br>S1 | i90-7022 | i90-7022T | ComfortGuard Plus Surgical Gown, i500 | L-XLONG |
| i90-7032-<br>S1 | i90-7032T-<br>S1 | i90-7032 | i90-7032T | ComfortGuard Plus Surgical Gown, i500 | XL-XLONG |
| i90-7042-<br>S1 | i90-7042T-<br>S1 | i90-7042 | i90-7042T | ComfortGuard Plus Surgical Gown, i500 | XXL-XLONG |
| i90-8000-<br>S1 | i90-8000T-<br>S1 | i90-8000 | i90-8000T | ComfortGuard Surgical Gown, i500 | S |
| i90-8010-<br>S1 | i90-8010T-<br>S1 | i90-8010 | i90-8010T | ComfortGuard Surgical Gown, i500 | M |
| i90-8020-<br>S1 | i90-8020T-<br>S1 | i90-8020 | i90-8020T | ComfortGuard Surgical Gown, i500 | L |
| i90-8030-<br>S1 | i90-8030T-<br>S1 | i90-8030 | i90-8030T | ComfortGuard Surgical Gown, i500 | XL |
| i90-8040-<br>S1 | i90-8040T-<br>S1 | i90-8040 | i90-8040T | ComfortGuard Surgical Gown, i500 | XXL |
| i90-8022-<br>S1 | i90-8022T-<br>S1 | i90-8022 | i90-8022T | ComfortGuard Surgical Gown, i500 | L-XLONG |
| i90-8032-<br>S1 | i90-8032T-<br>S1 | i90-8032 | i90-8032T | ComfortGuard Surgical Gown, i500 | XL-XLONG |
| i90-8042-<br>S1 | i90-8042T-<br>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 of<br>Comparison | Device<br>Description | ComfortGuard Plus<br>Surgical Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimberly-Clark<br>ULTRA Surgical Gown ,<br>code 951xx<br>(K080795) | Kimberly-Clark ULTRA<br>Film-Reinforced Surgical<br>Gown, code 954xx, 955xx<br>(K080795) |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Manufacturer | GRI | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. |
| | Product Trade<br>Name | ComfortGuard Plus<br>Surgical Gown, i500 | ComfortGuard Surgical<br>Gown, i500 | ULTRA Surgical Gown | ULTRA Film-Reinforced<br>Surgical 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 |
| | Classification<br>Name | Surgical Apparel | Surgical Apparel | Surgical Apparel | Surgical Apparel |
| | Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA |
| | AAMI PB 70<br>Classification | Level 3 | Level 3 | Level 3 | Level 4 |
| | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| | Predicate<br>Comparison | Subject device is<br>substantially equivalent to<br>the predicate in<br>classification and<br>sterilization method. | Subject device is<br>substantially equivalent to<br>the predicate in<br>classification and<br>sterilization method. | Predicate- This Device is a<br>Level 3 non-reinforced<br>surgical gown per K080795<br>submission, and is used as<br>the predicate. The subject<br>devices are substantially<br>equivalent to this gown for<br>their intended use. | This device is a level 4<br>Film-Reinforced surgical<br>gown per K080795<br>submission. Subject<br>devices are not<br>substantially equivalent to<br>this gown. This gown is not<br>considered as a predicate. |
| Element of<br>Comparison | Device<br>Description | ComfortGuard Plus Surgical<br>Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimberly-Clark<br>ULTRA Surgical Gown, code<br>951xx<br>(K080795) | Kimberly-Clark ULTRA Film-<br>Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) |
| Indications for Use | Indications for Use | ComfortGuard Plus Surgical<br>Gown, i500 are single use<br>surgical gowns intended to<br>protect surgical patients<br>and operating room<br>personnel from the transfer<br>of microorganisms, body<br>fluids, and particulate<br>material.<br>ComfortGuard Plus Surgical<br>Gown, i500 have been tested<br>and are classified as Level 3<br>in the critical zones per AAMI<br>Standard PB70 Liquid barrier<br>performance and<br>classification of protective<br>apparel and drapes intended<br>for use in healthcare<br>facilities. | ComfortGuard Surgical<br>Gown, i500 are single use<br>surgical gowns intended to<br>protect surgical patients<br>and operating room<br>personnel from the transfer<br>of microorganisms, body<br>fluids, and particulate<br>material.<br>ComfortGuard Surgical<br>Gown, i500 have been tested<br>and are classified as Level 3<br>in the critical zones per AAMI<br>Standard PB70 Liquid barrier<br>performance and<br>classification of protective<br>apparel and drapes intended<br>for use in healthcare<br>facilities. | The Kimberly-Clark ULTRA<br>Surgical Gowns and ULTRA<br>Film-Reinforced Surgical<br>Gowns are sterile, single use<br>surgical gown intended to<br>protect both the surgical<br>patient and the operating<br>room personnel from the<br>transfer of microorganisms,<br>body fluids and particulate<br>material.<br>The ULTRA Surgical Gowns<br>meet Level 3 of the AAMI<br>Liquid Barrier classifications,<br>and the ULTRA Film-<br>Reinforced Surgical Gowns<br>meet Level 4 of the AAMI<br>Liquid Barrier classifications. | The Kimberly-Clark ULTRA<br>Surgical Gowns and ULTRA<br>Film-Reinforced Surgical<br>Gowns are sterile, single use<br>surgical gown intended to<br>protect both the surgical<br>patient and the operating<br>room personnel from the<br>transfer of microorganisms,<br>body fluids and particulate<br>material.<br>The ULTRA Surgical Gowns<br>meet Level 3 of the AAMI<br>Liquid Barrier classifications,<br>and the ULTRA Film-<br>Reinforced Surgical Gowns<br>meet Level 4 of the AAMI<br>Liquid Barrier classifications. |
| Predicate<br>Comparison | Subject device is substantially<br>equivalent to the predicate in<br>its indications for use. The<br>subject device and predicate<br>are Level 3 surgical gowns. | Subject device is substantially<br>equivalent to the predicate in<br>its indications for use. The<br>subject device and predicate<br>are Level 3 surgical gowns. | Predicate- This Device is a<br>Level 3 non-reinforced<br>surgical gown per K080795<br>submission, and is used as<br>the predicate. | This device is a level 4 Film-<br>Reinforced surgical gown per<br>K080795 submission. Subject<br>devices are not substantially<br>equivalent to this gown. This<br>gown is not considered as a<br>predicate | |
| Element of<br>Comparison | Device<br>Description | ComfortGuard Plus<br>Surgical Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimberly-Clark<br>ULTRA Surgical Gown ,<br>code 951xx<br>(K080795) | Kimberly-Clark ULTRA<br>Film-Reinforced Surgical<br>Gown, code 954xx, 955xx<br>(K080795) |
| Technological Characteristics | Device<br>Description | The ComfortGuard Plus<br>Surgical Gown, i500 (i90-<br>70xx-S1) is comprised of a<br>single layer of polyolefin<br>nonwoven SMS fabric<br>throughout the entire<br>gown, with no additional<br>reinforcement. | The ComfortGuard<br>Surgical Gown, i500 (i90-<br>80xx-S1) is comprised of a<br>single layer of polyolefin<br>nonwoven SMS fabric<br>throughout the entire<br>gown, with no additional<br>reinforcement. | Predicate Kimberly-Clark<br>ULTRA Gown is a full-<br>length, nonwoven SMS<br>polypropylene gown. | Kimberly-Clark ULTRA<br>Film-Reinforced Gown is a<br>full-length, nonwoven<br>SMS polypropylene gown.<br>The ULTRA Film-<br>Reinforced Surgical Gown<br>is film-reinforced for<br>higher barrier protection. |
| | | The ComfortGuard Plus<br>Surgical Gown, i500 (i90-<br>70xx-S1) is provided with<br>neck binder, hook and<br>loop tabs, belt ties,<br>removable transfer<br>accessory, and cuffs. | The ComfortGuard<br>Surgical Gown, i500 (i90-<br>80xx-S1) is provided with<br>neck binder with hook<br>and loop tabs, belt ties,<br>removable transfer<br>accessory, and cuffs. | Predicate Kimberly-Clark<br>ULTRA Gown is<br>constructed with raglan<br>sleeves, hook-and-loop<br>neck closures, and tie<br>waist closures. | Kimberly-Clark ULTRA<br>Film-Reinforced Gown is<br>constructed with raglan<br>sleeves, hook-and-loop<br>neck closures, and tie<br>waist closures. |
| Element<br>of | Device<br>Description | ComfortGuard Plus Surgical<br>Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimberly-Clark<br>ULTRA Surgical Gown,<br>code 951xx<br>(K080795) | Kimberly-Clark ULTRA<br>Film-Reinforced Surgical<br>Gown, code 954xx, 955xx<br>(K080795) |
| Technological Characteristics (cont.) | | The ComfortGuard Plus<br>Surgical Gown, i500 (i90-<br>70xx-S1) is constructed with<br>or without thumb-hooks in<br>cuffs. | The ComfortGuard Surgical<br>Gown, i500 (i90-80xx-S1)<br>constructed with or without<br>thumb-hooks in cuffs. | The predicate does not<br>have thumb-hooks in<br>cuffs. | Kimberly-Clark ULTRA<br>Film-Reinforced Gown<br>does not have thumb-<br>hooks in cuffs. |
| | Design<br>Differences | The ComfortGuard Plus<br>Surgical Gown, i500 (i90-<br>70xx-S1) is constructed with<br>pleats in the back panels. | The ComfortGuard Surgical<br>Gown, i500 (i90-80xx-S1)<br>constructed with pleats in<br>the back panels. | The predicate is not<br>constructed with pleats in<br>the back. | Kimberly-Clark ULTRA<br>Film-Reinforced Gown is<br>not constructed with<br>pleats in the back. |
| | | The ComfortGuard Plus<br>Surgical Gown, i500 (i90-<br>70xx-S1) is constructed with<br>a lower basis weight SMS in<br>the back panels. | The ComfortGuard Surgical<br>Gown, i500 (i90-80xx-S1) is<br>constructed with a lower<br>basis weight SMS in the back<br>panels. | The predicate utilizes the<br>same basis weight SMS<br>throughout the entire<br>gown. | Kimberly-Clark ULTRA<br>Film-Reinforced Gown is<br>comprised of multiple<br>materials and is not<br>considered as a predicate. |
| | Predicate<br>Comparison | The addition of thumb-hooks,<br>back pleats, and the use of a<br>lighter basis weight material<br>in the back panels does not<br>impact the performance of<br>the gown in accordance with<br>AAMI PB70 requirement, and<br>therefore is substantially<br>equivalent to the predicate. | The addition of thumb-<br>hooks, back pleats, and the<br>use of a lighter basis weight<br>material in the back panels<br>does not impact the<br>performance of the gown in<br>accordance with AAMI PB70<br>requirement, and therefore<br>is substantially equivalent to<br>the predicate. | The predicate Kimberly-<br>Clark Ultra Surgical Gown<br>does not include these<br>Design features | The predicate Kimberly-<br>Clark Ultra Film-<br>Reinforced Surgical Gown<br>does not include these<br>Design features |
| Element of<br>Comparison | Device<br>Description | ComfortGuard Plus<br>Surgical Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimberly-Clark<br>ULTRA Surgical Gown ,<br>code 951xx<br>(K080795) | Kimberly-Clark ULTRA<br>Film-Reinforced Surgical<br>Gown, code 954xx, 955xx<br>(K080795) |
| Technological Characteristics (cont.) | Material<br>Composition | Single layer of Soft SMS<br>(polyolefin nonwoven) in<br>the front and sleeve,<br>single layer of SMS<br>(Polyolefin nonwoven) in<br>the back panels with a<br>lower basis weight SMS | Single layer of SMS<br>(polyolefin nonwoven) in<br>the front and sleeve,<br>single layer of SMS<br>(Polyolefin nonwoven) in<br>the back panels with a<br>lower basis weight SMS | Single Layer of SMS<br>(polyolefin nonwoven)<br>throughout the entire<br>gown | Multi-layer construction<br>(SMS & Film lamination)<br>in the entire front body<br>and sleeve, single layer of<br>SMS (polyolefin<br>nonwoven) in back panels |
| | Material<br>Additives | Alcohol-Repellency to<br>Front Body and Sleeves<br>material<br>Anti-Static throughout | Alcohol-Repellency to<br>Front Body and Sleeves<br>material<br>Anti-Static throughout | Alcohol-Repellency<br>throughout the entire<br>gown.<br>Anti-Static throughout | Alcohol-Repellency<br>throughout the entire<br>gown.<br>Anti-Static throughout |
| | | the entire gown<br>Softness treatment to<br>Body and Sleeves<br>material | the entire gown<br>No softness treatment | the entire gown<br>N/A | the entire gown<br>N/A |
| | Predicate<br>Comparison | The material additives do<br>not impact the<br>performance of the gown<br>in accordance with AAMI<br>PB70 and ISO 10993-1<br>requirements, and<br>therefore is substantially<br>equivalent to the<br>predicate. | The material additives do<br>not impact the<br>performance of the gown<br>in accordance with AAMI<br>PB70 and ISO 10993-1<br>requirements, and<br>therefore is substantially<br>equivalent to the<br>predicate. | The predicate Kimberly-<br>Clark Ultra Surgical Gown<br>meets the performance<br>requirements of AAMI<br>PB70 and ISO 10993-1 per<br>K080795 submission. | The Kimberly-Clark Ultra<br>Film-Reinforced Surgical<br>Gown meets the<br>performance<br>requirements of AAMI<br>PB70 and ISO 10993-1 per<br>K080795 submission. |
| Element of<br>Comparison | Device<br>Description | ComfortGuard Plus<br>Surgical Gown, i500<br>(i90-70xx-S1) | ComfortGuard Surgical<br>Gown, i500<br>(i90-80xx-S1) | Predicate Kimb…
