(133 days)
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. Stertlization parameters are as follows:
Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)
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.
The provided text describes the non-clinical testing performed on the ProPel SG3™ Surgical Gown to demonstrate its equivalence to a predicate device. It is important to note that this is a 510(k) submission, which aims to show substantial equivalence, not necessarily a study proving clinical effectiveness in the same way a new drug or high-risk device might.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Test Method/Applicable Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 | --- (No explicit quantitative acceptance criteria listed; qualitative comparison) | 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 |
| 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 | --- (No explicit acceptance criteria; result is a specific measurement) | 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 <151>/ISO 10993-11 | Temperature rise within acceptable limits | PASS |
| Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence of systemic toxicity | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to non-clinical testing of the physical and biological properties of the surgical gown material and design. For each test, "specimens" or "gowns" would be used as samples. However, the exact sample size (N) for each specific test (e.g., number of gowns for tensile strength, number of fabric pieces for hydrostatic resistance, number of biological samples for cytotoxicity) is not explicitly stated in this summary. For Evaporative Resistance, it mentions "average of 3 specimens".
The data provenance (country of origin, retrospective/prospective) is not provided in this document. Given that it's non-clinical testing of a manufactured product, it is likely that the testing was performed in a controlled laboratory environment, but the location is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical, laboratory-based study for a surgical gown. It does not involve medical imaging, diagnosis, or clinical decision-making by human experts where "ground truth" would be established by referring radiologists or other clinicians. The "ground truth" or "acceptance criteria" for these tests are based on established national and international standards (like ANSI/AAMI, ASTM, ISO, AATCC, 16 CFR, USP), which reflect a consensus of scientific and technical experts in materials science, biology, and medical device regulations. Therefore, this question is not applicable in the context of this device and study type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is non-clinical laboratory testing against predefined, objective standards, an adjudication method like 2+1 or 3+1 (typically used for resolving discrepancies in expert interpretations) is not applicable. The 'adjudication' is inherent in the test method itself, where results are measured objectively and compared against numerical acceptance criteria in a pass/fail manner.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is performed for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images). This device is a surgical gown, which is a physical barrier protection device. Therefore, an MRMC study and effects related to human reader improvement with AI assistance are not applicable. The document explicitly states "SUMMARY OF CLINICAL TESTING Not Applicable", further confirming no clinical effectiveness study (which would include MRMC) was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm without human involvement. Since the device is a surgical gown and not an AI-powered diagnostic or assistive tool, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of the surgical gown is based on established national and international standards and test methods. These standards define measurable physical and biological properties (e.g., tensile strength, tear strength, barrier performance, biocompatibility) and their respective acceptance criteria.
8. The sample size for the training set
This question typically applies to machine learning or AI models. Since this is non-clinical testing of a physical medical device (surgical gown), there is no "training set" in the context of an AI algorithm. The gown samples tested were used to demonstrate compliance with the specified performance standards.
9. How the ground truth for the training set was established
As there is no "training set" for an AI algorithm in this context, this question is not applicable. The "ground truth" for evaluating the gown's performance was established by recognized industry standards and test methodologies.
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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"
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(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).
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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
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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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510(k) Summary K241214
DATE PREPARED
September 6, 2024
| Manufacturer Name | Standard Textile Co., Inc.One Knollcrest DriveCincinnati, OH 45237 |
|---|---|
| Official Contact | Richard M. Holbert, Jr., PhDVice President, Research and DevelopmentTelephone: (513) 384-4189Email: rholbert@standardtextile.com |
| Representative/Consultant | Catherine Kang, PhDRQM+2790 Mosside Blvd Suite 800,Monroeville, PA 15146Telephone: (312) 318-4730Email: 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 | PrimaryPredicate |
|---|---|---|
| K922753 | ComPel XTR/Standard Textile Co., Inc. | ✓ |
The predicate device has not been subject to a design related recall.
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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)
| ItemNumber | Gown Size TagColor | GownSize |
|---|---|---|
| 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.
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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.
| DeviceCharacteristic | ComPel XTR(Predicate Device K922753) | ProPel SG3™ Surgical Gown(Subject Device: K241214) | Comparison |
|---|---|---|---|
| Product Code/Regulation | FYA878.4040 | FYA878.4040 | Same |
| ProductClassification | II | II | Same |
| Intended Use | ComPel XTR is intended to beworn by operating roompersonnel during surgicalprocedures to protect both thesurgical patient and theoperating room personnelfrom transfer ofmicroorganisms, body fluids,and particulate material. | ProPel SG3™ Surgical Gown isintended to be worn by operating roompersonnel during surgical procedures toprotect both the surgical patient and theoperating room personnel from transferof microorganisms, body fluids, andparticulate material. | Same |
| Indication forUse | ComPel XTR Surgical gownsare intended to be worn byoperating room personnelduring surgical procedures toprotect them by inhibiting themigration of liquids throughthe surface of the critical areasof the gown. When processedaccording to instructions,ComPel XTR Surgical gownswill function and perform as asurgical gown. The ComPelXTR Surgical gowns arereusable through 75 wash, dry,and sterilization cycles. Theyare manufactured anddistributed as non-sterilesurgical gowns that areintended to be sterilized andprocessed by health carefacilities and/or contractsterilization/laundrycompanies. | ProPel SG3™ Surgical Gown isintended to protect both surgicalpatients and operating room personnelfrom the transfer of microorganisms,body fluids, and particulate material.They are classified as Level 3 surgicalgowns in accordance with ANSI/AAMIPB70-2022.The reusable Propel Surgical Gown isprovided non-sterile and must besterilized before use. Sterilizationparameters are as follows:Prevacuum Steam Sterilization:132°C/270°F (temperature)/ 4 minutes(exposure time)/15 minute (dry time)Item Number Gown SizeTag Color GownSize7565CC17 Yellow SM7565CC16 Gold MD7565CC15 Green LG7565CC14 Red XL7565CC13 Orange 2XL7565CC12 Purple 3XL | Similar. Both devices aresurgical gowns that areindicated to protectoperating roompersonnel. |
| ANSI/AAMIPB70 LevelClassification inCritical Zones | Level 3* | Level 3 | Similar. Predicatepredated standards fortesting but wassubsequently confirmed |
| DeviceCharacteristic | ComPel XTR(Predicate Device K922753) | ProPel SG3TM Surgical Gown(Subject Device: K241214) | Comparison |
| to meet ANSI/AAMIPB70, which the subjectdevice 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 ventand mesh | Similar. Both devicesinclude tape ties andsnaps for fastening thegown, 100% polyesterknit cuffs andoverlapping back panels.The addition of a ventand mesh in the subjectdevice does not impactsafety or effectiveness. |
| Materials | ● 100% dyed Dacronpolyester with siliconecoating (outer ply criticalzone)● 100% polyester withcarbon yarns (inner plycritical zone and backpanels) | ● 100% polyester with siliconecoating (outer ply front andsleeves)● Polyester with electrostaticdissipative yarn (graphene) andsilicone coating (inner ply front,sleeves, outer back panels) | Similar. Both gownscontain 100% polyesterwith silicone coating.The subject deviceincludes additionalmaterials that passedbiocompatibility testing. |
| Color | Blue | Green | Different. Subject devicepassed biocompatibilitytesting. No impact onsafety or effectiveness. |
| Sizes | Small/mediumLarge/extra large2XL | SmallMediumLargeExtra Large2XL3XL | Similar. Both gowns areavailable in a variety ofsizes. |
| Reusable | Yes, up to 75 times | Yes, up to 60 times | Both gowns are reusablewith fewer reuses for thesubject device. |
| Sterility | Provided nonsterile to userfor steam sterilization | Provided nonsterile to user forsteam sterilization | Same |
| TensileStrength | Warp/Fill150 lbf/123 lbf | $\ge$ 30 N ( $\ge$ 7 lbf) | Similar. Predicatepredated currentstandards but has beentested against therequirements.Performance of thesubject devicedemonstrates the productmeets this requirement. |
| Tear Strength | N/A | $\ge$ 10 N ( $\ge$ 2.3 lbf) | Similar. Predicatepredated currentstandards but has beentested against therequirements. |
| DeviceCharacteristic | ComPel XTR(Predicate Device K922753) | ProPel SG3TM Surgical Gown(Subject Device: K241214) | Comparison |
| Seam Strength | N/A | ≥ 30 N (≥ 7 lbf) | Performance of thesubject devicedemonstrates the productmeets this requirement.Different. Predicatepredated currentstandards. Performanceof the subject devicedemonstrates the productmeets this requirement. |
| HydrostaticResistance | 25 lbs/14 lbs (min.)Mullens Hydrostat (1X/75X) | ≥ 50 cm (Level 3) | Similar. Predicatepredated standards fortesting but wassubsequently confirmedto meet ANSI/AAMIPB70 Level 3requirements, which thesubject device alsomeets. |
| ImpactPenetration | N/A | ≤ 1.0 g (Level 3) | |
| Lint Generation | <100 (Linting coefficient of 3) | Linting coefficient of 3 | Same |
| Flammability | Class I | Class I | Same |
| Cytotoxicity | Under the conditions of thestudy, the device is non-cytotoxic | Under the conditions of the study, thedevice is non-cytotoxic | Same |
| Sensitization | Under the conditions ofstudy, not a sensitizer | Under the conditions of study,not a sensitizer | Same |
| Irritation | Under the conditions ofstudy, not an irritant | Under the conditions of study,not an irritant | Same |
| Pyrogenicity | N/A | Non-pyrogenic | Different. Predicatepredated standards fortesting. Performance ofthe subject devicedemonstrates the productis nonpyrogenic. |
| Acute SystemicToxicity | No acute systemic toxicity | No acute systemic toxicity | Same |
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- At the time of 510(k) clearance, AAMI levels for surgical gowns had not yet been established. Testing subsequently performed established that the gown meets AAMI PB70 Level 3 requirements.
SUMMARY OF NON-CLINICAL TESTING
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
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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 <151> Pyrogen Test
The table below provides a summary of non-clinical testing performed.
| TestMethodology | 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 |
| HydrostaticResistance | AATCC Method 127/ANSI/AAMI PB70 | ≥ 50 cm per AAMI PB70 for Level 3 | PASS |
| ImpactPenetration | ATCC Method 42/ANSI/AAMI PB70 | ≤ 1.0 g per AAMI PB70 for Level 3 | PASS |
| Lint Generation | ISO 9073-10 | --- | Coefficient forlinting is 3 forboth predicate andsubject device |
| Flammability | 16 CFR 1610 | Pass Class I Flammability | PASSClass I |
| Snap Strength | ASTM D4846-96 | Fasteners provide peel strength of ≤ 1.5 lbf(easy doff) and shear force ≥ 4.5 lbf (secure) | PASS |
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| TestMethodology | Test Method/Applicable Standard(s) | Acceptance Criteria | Result |
|---|---|---|---|
| EvaporativeResistance | 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 ZoneFabric WeightTesting | ASTM D3776/D3776M-20 | --- | Gown criticalzone fabricconstructionweighs less than7.83 OSY |
| Use LifeTracking | --- | QCM label is legible and RFID Chip can beread 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 dermalcontact sensitization | PASS |
| Irritation | ISO 10993-23 | No erythema, no edema | PASS |
| Pyrogenicity | USP <151>/ISO 10993-11 | Temperature rise within acceptable limits | PASS |
| Acute SystemicToxicity | 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.
§ 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.