(97 days)
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
This document describes the premarket notification (510(k)) for the StringKing Disposable Isolation Gown (K212633). This is a disposable medical device intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It is a Class II device and is not intended for use in the operating room.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for Level 3 barrier protection, along with other physical performance and biocompatibility standards.
| Test Category | Specific Test (Standard) | Acceptance Criteria (Predicate Device K202310 Performance, if available/relevant) | Reported Device Performance (StringKing Disposable Isolation Gown) | Result |
|---|---|---|---|---|
| Barrier Protection | ANSI/AAMI PB70:2012 | Level 3 | Meets Level 3 requirements | Same (Meets Level 3) |
| Barrier Protection | Water Resistance: Hydrostatic Pressure Test - AATCC 127:2017 (cm) | Passed at ≥ 50cm (Predicate Chest: Mean = >151, Min = 155, Max = >155; Sleeve Seam: Mean = >165, Min = 171, Max = >173) | Fabric (body): Mean 170.33, Min 128.87, Max 196.87; Sleeve: Mean 126.60, Min 54.83, Max 189.40; Armhole: Each lot tested had less than 4 failures, meeting AQL 4.0. | Both passed at ≥ 50cm |
| Barrier Protection | Water Resistance: Impact Penetration Test - AATCC 42 | Passed at ≤ 1.0g (Predicate Chest: Mean = <0.1, Min = <0.1, Max = .5; Sleeve Seam: Mean = <0.1, Min = <0.1, Max = <0.1) | Fabric (body): Mean 0.01, Min 0.00, Max 0.11; Sleeve: Mean 0.03, Min 0.01, Max 0.38; Armhole: Mean 0.02, Min 0.00, Max 0.16 | Both passed at ≤ 1.0g |
| Physical Properties | Flammability of Clothing Textiles - 16 CFR Part 1610 (a) | Class I (average > 3.5 seconds) | Mean 5.41, Min 1.63, Max 7.87 | Class 1: average > 3.5 seconds. Both passed. |
| Physical Properties | Tear Resistance - ASTM D1004* | Predicate: Max Load (lbf): Mean = 1.04, Min = .95, Max = 1.17; Max Extension (in): Mean = 1.01, Min = .91, Max = 1.10 | N/A (Not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20) | Subject device not tested as not required by relevant standards. |
| Physical Properties | General Tensile Testing - ASTMD882* | Predicate: Breaking Factor (lbf/in): Mean = 6.66, Min = 4.87, Max = 9.20; Tensile (Max) (MPa): Mean = 24.8, Min = 19.7, Max = 33.4; Tensile (Break) (MPa): Mean = 21.5, Min = 15.9, Max = 33.4; Elongation (%): Mean = 1061, Min = 945, Max = 1327; Modulus (MPa): Mean = 91.1, Min = 2.58, Max = 117 | N/A (Not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20) | Subject device not tested as not required by relevant standards. |
| Physical Properties | Trap Tear ASTM D5587-15 | Passed at ≥2.3lbf (Predicate: Mean = 5.10, Ind Min = 3.2, Ind Max = 7.0) | Length: Mean 3.80, Min 3.18, Max 4.46; Width: Mean 6.88, Min 6.26, Max 7.58 | Both passed at ≥2.3lbf |
| Physical Properties | Grab Tensile CD ASTM D5034 | Passed at ≥7lbf (Predicate: Mean = 21.95, Ind Min = 20.60, Ind Max = 23.30) | Length: Mean 23.75, Min 20.54, Max 25.91; Width: Mean 19.63, Min 17.10, Max 21.59 | Both passed at ≥7lbf |
| Physical Properties | ASTM D1683 Seam Strength | Predicate: Not included in 510k summary; assumed to meet relevant standards for its performance. | Sleeve: Mean 11.95, Min 6.48, Max 18.18; Armhole: Mean 12.30, Min 6.95, Max 17.41 | Subject device passed at ≥7lbf; predicate data not provided. |
| Biocompatibility | Cytotoxicity: ISO 10993-5:2009 | Non-Cytotoxic (Predicate: Pass: ISO 10993-1) | Pass (Grade 0: non-cytotoxic) | Same (Pass) |
| Biocompatibility | Skin Irritation: ISO 10993-10:2010(R)2014 | Non-Irritating (Predicate: Pass: ISO 10993-1) | Negligible (pass) (Specimen: 0.0 non-irritating) | Same (Pass) |
| Biocompatibility | Skin Sensitization: ISO 10993-10:2010(R)2014 | Non-Sensitizing (Predicate: Pass: ISO 10993-1) | No sensitization noted (pass) (Specimen: 0.0 non-sensitizing) | Same (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. However, it provides mean, min, and max values for various physical tests, implying multiple samples were used for each. For the hydrostatic pressure and impact penetration tests, the results include mean, min, and max values for "Fabric (body)", "Sleeve", and "Armhole", suggesting multiple measurements across different regions of the gown. For the armhole hydrostatic pressure, it mentions "Each lot tested had less than 4 failures", indicating testing across lots.
- Data Provenance: The tests were non-clinical performance data and biocompatibility tests. The document does not specify the country of origin where the tests were explicitly conducted. It is implied that these are lab-based tests. The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, based on the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This device is a physical product (disposable isolation gown), not an AI/software device requiring human expert annotation for "ground truth". The "ground truth" for this device is established by its physical and biological performance against standardized, internationally recognized test methods (e.g., AAMI, AATCC, ASTM, ISO, CPSC).
- Therefore, the concept of "experts" to establish ground truth in the traditional sense of image interpretation or clinical diagnosis is not applicable here. The "experts" verifying the device's performance would be qualified lab technicians and engineers performing the standardized tests, and subsequently regulatory reviewers from the FDA.
4. Adjudication Method for the Test Set
- Not applicable. This is not an observational study requiring adjudication of interpretations. The tests are objective measurements of physical and biological properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document pertains to a disposable physical medical device (isolation gown), not a diagnostic or AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not applicable. This is a physical medical device, not an algorithm or software. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human interaction.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective, standardized measurements and laboratory testing results as defined by:
- ANSI/AAMI PB70:2012 (Liquid Barrier Performance Classification)
- AATCC 127:2017 (Water Resistance: Hydrostatic Pressure Test)
- AATCC 42 (Water Resistance: Impact Penetration Test)
- 16 CFR Part 1610 (Flammability of Clothing Textiles)
- ASTM D5587-15 (Tearing Strength of Fabrics by Trapezoid Procedure)
- ASTM D5034 (Breaking Strength and Elongation of Textile Fabrics (Grab Test))
- ASTM D1683 (Failure in Sewn Seams of Woven Fabrics)
- ISO 10993-5:2009 (Biological Evaluation - In-Vitro Cytotoxicity)
- ISO 10993-10:2010(R)2014 (Biological Evaluation - Irritation and Delayed-Type Hypersensitivity)
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the context of data used to train an algorithm. The device's manufacturing processes would be subject to quality control, but this is distinct from a "training set" for an AI model.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the AI/ML context for this physical device.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 24, 2021
String King Lacrosse, LLC % Sharon Morrow Regulatory Affairs Consultant Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K212633
Trade/Device Name: Disposable Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: August 3, 2021 Received: August 19, 2021
Dear Sharon Morrow:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely,
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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) K212633
Device Name Disposable Isolation Gown
Indications for Use (Describe)
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
| 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)
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K212633
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER
String Kina Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA, 90248 USA Tel: +1.508.654.1988 Fax: N/A
Contact Person: Thomas Frasca Date Prepared: November 23, 2021
DEVICE 11.
| Name of Device: | Disposable Isolation Gown |
|---|---|
| Classification Name: | Surgical Isolation Gown |
| Regulation: | 21 CFR § 878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FYC |
= PREDICATE DEVICE
| Predicate Manufacturer: | Wildcat PPE, LLC |
|---|---|
| Predicate Trade Name: | Wildcat PE Surgical Isolation Gown Full Back |
| Predicate 510(k): | K202310 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
V. INDICATIONS FOR USE
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gownsare not intended for use in the operating room. The StringKing Disposable Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided nonsterile.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence in Table 1 below.
| Device | Proposed Device -Disposable IsolationGown | Predicate Device -Wildcat PE SurgicalIsolation Gown FullBack | Result |
|---|---|---|---|
| Manufacturer | StringKing | Wildcat PPE, LLC | N/A |
| 510K Number | K212633 | K202310 | N/A |
| Product CommonName | Disposable Isolation Gown | Surgical Isolation Gown | N/A |
| Product Code | FYC | FYC | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| IntendedUse/Indications forUse | The StringKing DisposableIsolation Gown is intended toprotect health care personnel andhealth care patients from thetransfer of microorganisms, bodyfluids and particulate material.These gownsare not intended foruse in the operating room. TheStringKing Disposable IsolationGown meets the requirements ofan AAMI Level 3 barrier protectionfor an isolation gown perANSI/AAMI PB70:2012 LiquidBarrier Performance Classificationof Protective Apparel DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70). TheString King Disposable IsolationGown is a single use, disposablemedical device and is providednon-sterile. | Wildcat PE Surgical Isolation GownFull Back is intended to protecthealth care patients and health carepersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. Not intended foruse in the operating room. Inaddition, The Wildcat PE SurgicalIsolation Gown Full Back meets therequirements of an AAMI Level 3barrier protection for an isolationgown per ANSI/AAMI PB70:2012Liquid Barrier and PerformanceClassification of Protective Appareland Surgical Drapes Intended forUse in Health Care Facilities(ANSI/AAMI PB70). The Wildcat PESurgical Isolation Gown Full Back isa single use, disposable medicaldevice provided non-sterile. | Same |
| MaterialComposition | Polyethylene LDPECAS # 9002-88-4 | Linear Low-Density Polyethylene(LLDPE) | Same |
| Design Features | Hook and Loop Neck ClosureClosed back - tie at waistThumb Loops | Tabs Tie in the Middle of BackThumbhole at Cuff | Similar; predicatedevice has ties atneck whilesubject devicehas hook andloop |
| Color | BlueCAS # 147-14-8 | Blue (CAS unknown) | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
Table 1 – Comparison of Technological Characteristics
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VII. NON-CLINICAL PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Device | Proposed Device -DisposableIsolation Gown | Predicate Device -Wildcat PE SurgicalIsolation Gown (K202310) | Result |
|---|---|---|---|
| ANSI/AAMIPB70:2012 | Level 3 | Level 3 | Same |
| Water ResistanceHydrostaticPressureTest - AATCC127:2017 (cm) | Fabric (body)Mean 170.33Min 128.87Max 196.87SleeveMean 126.60Min 54.83Max 189.40ArmholeEach lot tested had lessthan 4 failures in thearmhole region; thusmeeting therequirement of AQL 4.0. | Chest:Mean = $>151$Min = 155Max = $>155$Sleeve Seam: Mean = $>165$Min = 171Max = $>173$ | Both the subject and predicatedevice passed at $\ge$ 50cm |
| Water ResistanceImpact PenetrationTest AATCC 42 | Fabric (body)Mean 0.01Min 0.00Max 0.11SleeveMean 0.03Min 0.01Max 0.38ArmholeMean 0.02Min 0.00Max 0.16 | Chest:Mean = $<0.1$Min = $<0.1$Max = .5Sleeve Seam: Mean = $<0.1$Min = $<0.1$Max = $<0.1$ | Both the subject andpredicate device passed at$\le$ 1.0g |
| Flammability ofClothing Textiles - 16CFR Part 1610 (a) | Mean 5.41Min 1.63Max 7.87 | Class I | Class 1: average > 3.5seconds. Both the subject andpredicate device passed withan average of $\ge$ 3.5 seconds. |
| Tear Resistance -ASTM D1004* | N/A | Max Load (lbf): Mean = 1.04Min = .95Max = 1.17Max Extension (in):Mean = 1.01Min = .91Max = 1.10 | Subject device not tested asthis method is not requiredby ANSI/AAMI PB70:2012or ASTM F2407-20 |
| General TensileTesting - ASTMD882* | N/A | Breaking Factor (lbf/in):Mean = 6.66Min = 4.87Max = 9.20Tensile (Max) (MPa):Mean = 24.8Min = 19.7Max = 33.4Tensile (Break) (MPa):Mean = 21.5Min = 15.9Max = 33.4Elongation (%): Mean = 1061Min = 945Max = 1327Modulus (MPa): Mean = 91.1Min = 2.58Max = 117 | Subject device not tested asthis method is not requiredby ANSI/AAMI PB70:2012or ASTM F2407-20 |
| Trap Tear ASTMD5587-15 | LengthMean 3.80Min 3.18Max 4.46WidthMean 6.88Min 6.26Max 7.58 | Mean = 5.10Ind Min = 3.2Ind Max = 7.0 | Both the subject andpredicate device passed at≥2.3lbf |
| Grab Tensile CDASTM D5034 | LengthMean 23.75Min 20.54Max 25.91WidthMean 19.63Min 17.10Max 21.59 | Mean = 21.95Ind Min = 20.60Ind Max = 23.30 | Both the subject andpredicate device passed at≥7lbf |
| ASTM D1683Seam Strength | SleeveMean 11.95Min 6.48Max 18.18ArmholeMean 12.30Min 6.95Max 17.41 | Not included in 510k summary | The subject device passed at≥7lbf; test data not providedin 510k summary forpredicate device |
| Liquid BarrierPerformanceClassificationProperties | Device was tested inaccordance withAAMI PB70:2012and meets Level 3requirements for asurgical gown. | Device was tested inaccordance with AAMIPB70:2012 and meets Level 3requirements for a surgicalgown. | Same |
| Biocompatibility | |||
| Cytotoxicity: ISO10993-5:2009 [FRRecognition #2-245]Study # JN2010831 | PassTest Articles:Grade 0 (non-cytotoxic) | Details not included in 510ksummary; Summary states "Pass:ISO 10993-1" | Same |
| Skin Irritation: ISO10993-10:2010(R)2014 [FRRecognition 2-174]Study #: JN2010832 | Negligible (pass)Specimen:0.0 non-irritating | Details not included in 510ksummary; Summary states "Pass:ISO 10993-1" | Same |
| Skin Sensitization:ISO 10993-10:2010(R)2014 [FRRecognition 2-174]Study #: JN2010833 | No sensitization noted(pass)Specimen:0.0non- sensitizing | Details not included in 510ksummary; Summary states "Pass:ISO 10993-1" | Same |
| Sterilization Modality | None (Non-Sterile) | None (Non-Sterile) | Same |
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*These tests are specifically for tear and tensile properties of thin plastic sheeting.
The following standards were utilized in performance and biocompatibility testing of the StringKing Disposable Isolation Gown.
Table 2 – Use of Standards
| StandardsOrganization | Standards Title | |
|---|---|---|
| PB70 | AAMI | AAMI PB70 Liquid Barrier Performance Classification of ProtectiveApparel |
| TM 127 | AATCO | Water Resistance: Hydrostatic Pressure Test |
| TM 42 | AATCO | Water Resistance: Impact Penetration Test |
| F2407-20 | ASTM | Standard Specification for Surgical Gowns Intended for Usein Healthcare Facilities |
| D5034 | ASTM | Standard Test Method for Breaking Strength and Elongationof Textile Fabrics (Grab Test) |
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| D5587 | ASTM | Standard Test Method for Tearing Strength of Fabrics byTrapezoid Procedure |
|---|---|---|
| D1683 | ASTM | Standard Test Method for Failure in Sewn Seams of Woven Fabrics |
| Part 1610 | CPSC | Standard for the Flammability of Clothing Textiles |
| 10993-1 | ISO | ISO 10993-1 Biological Evaluation of Medical Devices- Part 1:Evaluation and |
| 10993-5 | ISO | Biological Evaluation of Medical Devices- Part 5: Tests forIn-Vitro Cytotoxicity |
| 10993-10 | ISO | Biological Evaluation of Medical Devices- Part 10: Tests forirritation and delayed-type hypersensitivity |
Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
Table 3 - Biocompatibility Testing
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K202310), manufactured by Wildcat PPE LLC.
§ 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.