(133 days)
Not Found
No
The 510(k) summary describes a surgical gown and its physical properties, materials, and sterilization parameters. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or diagnose a disease or condition.
No.
The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly states it is a reusable, woven surgical gown made of polyester with silicone coating and other materials, indicating it is a physical hardware device, not software.
Based on the provided text, the ProPel SG3TM Surgical Gown is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function for personal protective equipment (PPE) in a surgical setting.
- Device Description: The description details a reusable, woven surgical gown with specific material properties and barrier performance.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue.
- Testing: The non-clinical testing focuses on the physical properties and barrier performance of the gown, not on diagnostic accuracy or analytical performance.
Therefore, the ProPel SG3TM Surgical Gown is classified as a surgical gown, which is a type of medical device used for protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
ProPel SG3TM Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Sterilization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.
The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results of non-clinical testing demonstrated that the proposed device met its acceptance criteria or testing endpoints with the use of following standards:
- ANSI/AAMI PB70:2022: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
- ASTM F2407-20: Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
- 16 CFR 1610: Standard for flammability of clothing textiles
- AATCC Method 42: Test Method for Water Resistance: Impact Penetration
- AATCC Method 127: Test Method for Water Resistance: Hydrostatic Pressure
- ASTM D1683: Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
- ASTM D5034: Standard Test Method for Breaking Strength and Elongation of Textile Fabrics
- ASTM D5587: Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM F1868-17: Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials
- ASTM D4846-96 (2011): Standard Test Method for Resistance to Unsnapping of Snap Fasteners
- ISO 10993-5:2009: Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021: Biological evaluation of medical devices-Part 10: Tests for skin sensitization
- ISO 10993-11:2017: Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
- ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Tests for irritation
- USP Pyrogen Test
Key results: All tests passed their acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 10, 2024
Standard Textile Co., Inc. % Catherine Kang Senior Principal Consultant Ram+ 2790 Mosside Blvd Suite 800 Monroeville, Pennsylvania 15146
Re: K241214
Trade/Device Name: ProPel SG3TM Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: April 30, 2024 Received: August 9, 2024
Dear Catherine Kang:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is horizontally aligned.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241214
Device Name ProPel SG3TM Surgical Gown
Indications for Use (Describe)
ProPel SG37M Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Stertlization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
Item Number Gown Size Tag Color Gown Size 7565CC17 Yellow SM 7565CC16 Gold MD 7565CC15 Green LG 7565CC14 Red XL 7565CC13 Orange 2XL 7565CC12 Purple 3XL
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary K241214
DATE PREPARED
September 6, 2024
| Manufacturer Name | Standard Textile Co., Inc.
One Knollcrest Drive
Cincinnati, OH 45237 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Richard M. Holbert, Jr., PhD
Vice President, Research and Development
Telephone: (513) 384-4189
Email: rholbert@standardtextile.com |
| Representative/Consultant | Catherine Kang, PhD
RQM+
2790 Mosside Blvd Suite 800,
Monroeville, PA 15146
Telephone: (312) 318-4730
Email: ckang@rqmplus.com |
DEVICE INFORMATION
Device trade name, or proprietary name: ProPel SG3TM Surgical Gown Device common name: Surgical Gown Classification name: Gown, Surgical Product classification: II Recommended classification regulation: 21 CFR 878.4040 Product Code(s): FYA Panel: General Hospital
PREDICATE DEVICE IDENTIFICATION
The ProPel SG3™ Surgical Gown is substantially equivalent to the following predicate device:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|---------------------------------------|----------------------|
| K922753 | ComPel XTR/Standard Textile Co., Inc. | ✓ |
The predicate device has not been subject to a design related recall.
5
DEVICE DESCRIPTION
The ProPel SG3TM Surgical Gown is a reusable, woven surgical gown that provides an ANSI /AAMI PB70:2022 Level 3 Liquid Barrier Performance Barrier using 100% polyester with silicone coating in the critical zone. The critical zone inner ply and back of the surgical gown is made of polyester with electrostatic dissipative yarn (graphene) and silicone coating. The gown has polyester mesh and vented cape on the back panels of the gown for ventilation. The ProPel SG3TM Surgical Gown may undergo up to 60 reprocessing cycles.
The ProPel SG3™ Surgical Gown is available in small, medium, large, extra large (XL), 2XL and 3XL. The device will be sold as a non-sterile surgical gown that is to be laundered, sterilized and processed by the healthcare facility prior to first use and after each subsequent use.
INDICATIONS FOR USE
ProPel SG3™ Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.
The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Sterilization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
| Item
Number | Gown Size Tag
Color | Gown
Size |
|----------------|------------------------|--------------|
| 7565CC17 | Yellow | SM |
| 7565CC16 | Gold | MD |
| 7565CC15 | Green | LG |
| 7565CC14 | Red | XL |
| 7565CC13 | Orange | 2XL |
| 7565CC12 | Purple | 3XL |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device has the same intended use and similar technological characteristics to the predicate device. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.
6
ProPel SG3™ Surgical Gown has a similar design and dimensions and uses similar materials as the ComPel XTR cleared under K922753 as indicated in the table below and forms the basis for the determination of substantial equivalence.
| Device
Characteristic | ComPel XTR
(Predicate Device K922753) | ProPel SG3™ Surgical Gown
(Subject Device: K241214) | Comparison |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code/
Regulation | FYA
878.4040 | FYA
878.4040 | Same |
| Product
Classification | II | II | Same |
| Intended Use | ComPel XTR is 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. | ProPel SG3™ Surgical Gown is
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. | Same |
| Indication for
Use | ComPel XTR Surgical gowns
are intended to be worn by
operating room personnel
during surgical procedures to
protect them by inhibiting the
migration of liquids through
the surface of the critical areas
of the gown. When processed
according to instructions,
ComPel XTR Surgical gowns
will function and perform as a
surgical gown. The ComPel
XTR Surgical gowns are
reusable through 75 wash, dry,
and sterilization cycles. They
are manufactured and
distributed as non-sterile
surgical gowns that are
intended to be sterilized and
processed by health care
facilities and/or contract
sterilization/laundry
companies. | ProPel SG3™ Surgical Gown is
intended to protect both surgical
patients and operating room personnel
from the transfer of microorganisms,
body fluids, and particulate material.
They are classified as Level 3 surgical
gowns in accordance with ANSI/AAMI
PB70-2022.
The reusable Propel Surgical Gown is
provided non-sterile and must be
sterilized before use. Sterilization
parameters are as follows:
Prevacuum Steam Sterilization:
132°C/270°F (temperature)/ 4 minutes
(exposure time)/15 minute (dry time)
Item Number Gown Size
Tag Color Gown
Size
7565CC17 Yellow SM
7565CC16 Gold MD
7565CC15 Green LG
7565CC14 Red XL
7565CC13 Orange 2XL
7565CC12 Purple 3XL | Similar. Both devices are
surgical gowns that are
indicated to protect
operating room
personnel. |
| ANSI/AAMI
PB70 Level
Classification in
Critical Zones | Level 3* | Level 3 | Similar. Predicate
predated standards for
testing but was
subsequently confirmed |
| Device
Characteristic | ComPel XTR
(Predicate Device K922753) | ProPel SG3TM Surgical Gown
(Subject Device: K241214) | Comparison |
| | | | to meet ANSI/AAMI
PB70, which the subject
device also meets. |
| Design | ● Tape ties
● Metal snaps
● 100% polyester knit cuffs
● Overlapping back panels | ● Tape Ties
● Plastic interlocking snaps
● 100% polyester knit cuffs
● Overlapping back panels with vent
and mesh | Similar. Both devices
include tape ties and
snaps for fastening the
gown, 100% polyester
knit cuffs and
overlapping back panels.
The addition of a vent
and mesh in the subject
device does not impact
safety or effectiveness. |
| Materials | ● 100% dyed Dacron
polyester with silicone
coating (outer ply critical
zone)
● 100% polyester with
carbon yarns (inner ply
critical zone and back
panels) | ● 100% polyester with silicone
coating (outer ply front and
sleeves)
● Polyester with electrostatic
dissipative yarn (graphene) and
silicone coating (inner ply front,
sleeves, outer back panels) | Similar. Both gowns
contain 100% polyester
with silicone coating.
The subject device
includes additional
materials that passed
biocompatibility testing. |
| Color | Blue | Green | Different. Subject device
passed biocompatibility
testing. No impact on
safety or effectiveness. |
| Sizes | Small/medium
Large/extra large
2XL | Small
Medium
Large
Extra Large
2XL
3XL | Similar. Both gowns are
available in a variety of
sizes. |
| Reusable | Yes, up to 75 times | Yes, up to 60 times | Both gowns are reusable
with fewer reuses for the
subject device. |
| Sterility | Provided nonsterile to user
for steam sterilization | Provided nonsterile to user for
steam sterilization | Same |
| Tensile
Strength | Warp/Fill
150 lbf/123 lbf | $\ge$ 30 N ( $\ge$ 7 lbf) | Similar. Predicate
predated current
standards but has been
tested against the
requirements.
Performance of the
subject device
demonstrates the product
meets this requirement. |
| Tear Strength | N/A | $\ge$ 10 N ( $\ge$ 2.3 lbf) | Similar. Predicate
predated current
standards but has been
tested against the
requirements. |
| Device
Characteristic | ComPel XTR
(Predicate Device K922753) | ProPel SG3TM Surgical Gown
(Subject Device: K241214) | Comparison |
| Seam Strength | N/A | ≥ 30 N (≥ 7 lbf) | Performance of the
subject device
demonstrates the product
meets this requirement.
Different. Predicate
predated current
standards. Performance
of the subject device
demonstrates the product
meets this requirement. |
| Hydrostatic
Resistance | 25 lbs/14 lbs (min.)
Mullens Hydrostat (1X/75X) | ≥ 50 cm (Level 3) | Similar. Predicate
predated standards for
testing but was
subsequently confirmed
to meet ANSI/AAMI
PB70 Level 3
requirements, which the
subject device also
meets. |
| Impact
Penetration | N/A | ≤ 1.0 g (Level 3) | |
| Lint Generation | Pyrogen Test
The table below provides a summary of non-clinical testing performed.
| Test
Methodology | Test Method/
Applicable Standard(s) | Acceptance Criteria | Result |
|---------------------------|----------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Tensile Strength | ASTM D5034/
ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Tear Strength | ASTM D5587/
ASTM F2407-20 | ≥ 10 N (≥ 2.3 lbf) | PASS |
| Seam Strength | ASTM D1683/
ASTM F2407-20 | ≥ 30 N (≥ 7 lbf) | PASS |
| Hydrostatic
Resistance | AATCC Method 127/
ANSI/AAMI PB70 | ≥ 50 cm per AAMI PB70 for Level 3 | PASS |
| Impact
Penetration | ATCC Method 42/
ANSI/AAMI PB70 | ≤ 1.0 g per AAMI PB70 for Level 3 | PASS |
| Lint Generation | ISO 9073-10 | --- | Coefficient for
linting is 3 for
both predicate and
subject device |
| Flammability | 16 CFR 1610 | Pass Class I Flammability | PASS
Class I |
| Snap Strength | ASTM D4846-96 | Fasteners provide peel strength of ≤ 1.5 lbf
(easy doff) and shear force ≥ 4.5 lbf (secure) | PASS |
10
| Test
Methodology | Test Method/
Applicable Standard(s) | Acceptance Criteria | Result |
|-------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Evaporative
Resistance | ASTM F1868-17 | Evaporative resistance of critical zone
(average of 3 specimens) ≤ 350 Pa m²/W;
evaporative resistance of the back mesh (2-
ply average of 3 specimens) ≤ 5 Pa m²/W | PASS |
| Critical Zone
Fabric Weight
Testing | ASTM D3776/D3776M-20 | --- | Gown critical
zone fabric
construction
weighs less than
7.83 OSY |
| Use Life
Tracking | --- | QCM label is legible and RFID Chip can be
read at the beginning and end of use life
(after 60 reuses) | PASS |
| Cytotoxicity | ISO 10993-5 | Less than/equal to grade 2 (mild reactivity) | PASS |
| Sensitization | ISO 10993-10 | No evidence of causing delayed dermal
contact sensitization | PASS |
| Irritation | ISO 10993-23 | No erythema, no edema | PASS |
| Pyrogenicity | USP /
ISO 10993-11 | Temperature rise within acceptable limits | PASS |
| Acute Systemic
Toxicity | ISO 10993-11 | No mortality or evidence of systemic toxicity | PASS |
SUMMARY OF CLINICAL TESTING Not Applicable
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that ProPel SG3™ Surgical Gown is as safe, as effective, and performs as well as or better than the predicate device.