(128 days)
The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical non-sterile.
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
The provided text describes the acceptance criteria and the results of non-clinical tests for an Isolation Gown. This is a medical device, specifically protective apparel, and not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this document.
Here's the relevant information based on the provided text for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)):
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria for Level 3 Barrier | Result of Yellow Isolation Gown XXL | Result of Blue Isolation Gown XXL |
|---|---|---|---|---|
| Water Resistance: Hydrostatic Pressure Test | AATCC 127-2018e | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Water Resistance: Impact Penetration Test | AATCC 42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Breaking Strength and Elongation | ASTM D 5034-2009 (2017) | ≥30N(7lbf) | Passed | Passed |
| Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed |
| Seam Strength | ASTM D1683/D1683M-2017 (2018) | ≥30N (7lbf) | Passed | Passed |
| Lint and other particles generation in the dry state | ISO 9073-10:2003 | Reported Data | Total linting: Avg 187; Coeff of linting: Avg 2.3 | Total linting: Avg 584; Coeff of linting: Avg 2.8 |
| Thermal and Evaporative Resistance | ASTM F 1868-2017 | Reported Data | Evaporative resistance: 0.00217 | Evaporative resistance: 0.00198 |
| Flammability Test | 16 CFR Part 1610 | Class I | Passed | Passed |
| Mass Per Unit Area | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Non-sensitizing |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Negligibly irritating |
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 does not explicitly state the sample sizes for each specific test but indicates that tests were performed on "Yellow Isolation Gown XXL" and "Blue Isolation Gown XXL". The tests are non-clinical, related to material properties of the gown. Data provenance (country of origin, retrospective/prospective) is not provided as this is an evaluation of a physical medical device, not a data-driven model.
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)
Not applicable. This is a physical medical device (isolation gown), not an AI/ML device relying on expert interpretation for ground truth. Ground truth is established by physical and chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML device requiring adjudication of results.
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
Not applicable. This is a physical medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established international and national standards for performance and safety of protective apparel and medical devices. Specifically:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities (for liquid barrier performance)
- AATCC 127-2018e (Water Resistance: Hydrostatic Pressure Test)
- AATCC 42-2017 (Water Resistance: Impact Penetration Test)
- ASTM D 5034-2009 (2017) (Breaking Strength and Elongation)
- ASTM D 5587-2015 (Tearing Strength)
- ASTM D1683/D1683M-2017 (2018) (Seam Strength)
- ISO 9073-10:2003 (Lint and other particles generation)
- ASTM F 1868-2017 (Thermal and Evaporative Resistance)
- 16 CFR Part 1610 (Flammability Test)
- ISO 9073-1:1989 (Mass Per Unit Area)
- ISO 10993-1:2018, ISO 10993-5, ISO 10993-10 (Biocompatibility)
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set with established ground truth.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2022
Allmed Medical (Hubei) Protective Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221027
Trade/Device Name: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYC Dated: April 6, 2022 Received: April 6, 2022
Dear Ivy Wang:
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.
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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 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.
Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221027
Device Name Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Indications for Use (Describe)
The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical nonsterile.
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)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary (K221027)
(As requirement by 21 CFR 807.92)
Date prepared: 25th, March, 2022
A. Applicant:
Name: Allmed Medical (Hubei) Protective Products Co., Ltd Address: No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Contact Person: Vince Tian Title: General Manager of Quality Tel: 86 717 4215906 Fax: 86 717 4215989 Email: vince@allmed.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name:Isolation Gown Model: S. M. L. XL. XXL (Yellow, Blue)
Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
C. Predicate device: K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC
D. Indications for use of the device:
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The Isolation Gowns are intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile.
E. Device Description:
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
F. Non-clinical Test Conclusion
The Isolation Gowns were tested in accordance with the tests recommended in ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
| Test Item | Test Standard | AcceptanceCriteria forLevel 3 Barrier | Result of YellowIsolation GownXXL | Result of BlueIsolation GownXXL |
|---|---|---|---|---|
| WaterResistance:HydrostaticPressure Test | AATCC 127-2018e | ≥50 cmH2O perstandardANSI/AAMIPB70:2012 forlevel 3 | Passed | Passed |
| WaterResistance:ImpactPenetration Test | AATCC 42-2017 | ≤1.0g AQL: 4%Level 3 perstandardANSI/AAMIPB70:2012 forlevel 3 | Passed | Passed |
| BreakingStrength andElongation | ASTM D 5034-2009(2017) | ≥30N(7lbf) | Passed | Passed |
| Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed |
Based upon the document the following testing has been performed.
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| (2019) | ||||
|---|---|---|---|---|
| Seam Strength | ASTMD1683/D1683M-2017(2018) | ≥30N (7lbf) | Passed | Passed |
| Lint and otherparticlesgeneration in thedry state | ISO 9073-10:2003 | Reported Data | Lint and otherparticlesgeneration in the drystate[Material]Total linting:A: face 222B: face 152Average 187Coefficient of linting:A: face 2.3B: face 2.2Average 2.3 | Lint and otherparticlesgeneration in the drystate[Material]Total linting:A: face 527B: face 641Average 584Coefficient of linting:A: face 2.7B: face 2.8Average 2.8 |
| Thermal andEvaporativeResistance | ASTM F 1868-2017 | Reported Data | Evaporativeresistance(m2·kPa/W)[Material]: 0.00217 | Evaporativeresistance(m2·kPa/W)[Material]: 0.00198 |
| FlammabilityTest | 16 CFR Part 1610 | Class I | Passed | Passed |
| Mass Per UnitArea | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 |
Biocompatibility Testing
The biocompatibility evaluation for the Isolation Gown was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Isolation Gown is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
| Biocompatibility Evaluation | ||||
|---|---|---|---|---|
| Biological Effect | Standard | Result | ||
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
G. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| -------- | ----------------- | ------------------ | -------- |
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| 510K # | - | K160339 | - |
|---|---|---|---|
| Manufacturer | Allmed Medical ( Hubei ) ProtectiveProducts Co., Ltd | Cardinal Health 200, LLC | - |
| Product Name | Isolation Gown | Cardinal Health™ Isolation Gown | Similar |
| Level | Level 3 | Level 3 | Same |
| Product Code | FYC | FYC | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for use | The Isolation Gowns are intended toprotect health care patients and healthcare personnel from the transfer ofmicroorganisms, body fluids andparticulate material. Not intended foruse in the operating room. In addition,The Isolation Gowns meet therequirements of an AAMI Level 3barrier protection for an isolation gownper ANSI/AAMI PB70:2012 LiquidBarrier Performance and Classificationof Protective Apparel and DrapesIntended for Use in Health CareFacilities (ANSI/AAMI PB70). TheIsolation Gowns are a single use,disposable medical device providednon-sterile. | Cardinal HealthTM Isolation Gown isintended to protect health care patientsand health care personnel from thetransfer of microorganisms, body fluidsand particulate material. Not intendedfor use in the operating room. Inaddition, The Cardinal HealthTMIsolation Gown meets the requirementsof an AAMI Level 3 barrier protectionfor an isolation gown per ANSI/AAMIPB70:2012 Liquid Barrier Performanceand Classification of Protective Appareland Drapes Intended for Use in HealthCare Facilities (ANSI/AAMIPB70).The Cardinal HealthTMIsolation Gown is a single use,disposable medical device providednon-sterile. | Same |
| Design Feature | Tape Neck ClosureBelt TieElastic Cuffs | Medical Tape Neck ClosureWhite Belt TieElastic Cuffs | Similar |
| MaterialComposition | Body, Sleeves and Belt:PolypropyleneSMS non-wovenCuff: Polyester | Polyolefin (Polypropylene) SMSnonwoven | Similar |
| Color | Blue and Yellow | Blue and Yellow | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
Table 2 Performance Comparison of Proposed and Predicate Devices
| Element ofComparison | Proposed Device(Yellow) | Proposed Device(Blue) | Predicate Device(K160339)(Yellow) | Predicate Device(K160339)(Blue) | Comparison | ||
|---|---|---|---|---|---|---|---|
| Basis weight | 39.56g/m²(1.17 oz/yd²) | 40.62g/m²(1.20 oz/yd²) | Mean = 1.21Ind Min = 1.19 | Mean = 1.18Ind Min = 1.15 | Similar | ||
| Ind Max = 1.23Unit: oz/yd² | Ind Max = 1.20Unit: oz/yd² | ||||||
| Grab tensile MDASTM D5034 | Averagevalue:88.53N(20 lbs) | Averagevalue:139.39N(31.32 lbs) | Mean = 24.38Ind Min = 21.94Ind Max = 26.28Unit: lb | Mean = 22.23Ind Min = 20.42Ind Max = 24.03Unit: lb | Similar | ||
| Grab tensile CDASTM D5034 | Averagevalue:58.05N(13.05 lbs) | Averagevalue:77.01N(17.31 lbs) | Mean = 14.54Ind Min = 12.70Ind Max = 16.45Unit: lb | Mean = 14.18Ind Min = 12.40Ind Max = 15.76Unit: lb | Similar | ||
| Trap Tear MDASTM D5587-15 | Averagevalue:24.52N(5.51 lbs) | Averagevalue:34.42N(7.74 lbs) | Mean = 4.74Ind Min = 3.67Ind Max = 5.47Unit: lb | Mean = 4.40Ind Min = 3.26Ind Max = 5.54Unit: lb | Different | ||
| Trap Tear CDASTM D5587-15 | Averagevalue:15.13N(3.4 lbs) | Averagevalue:17.54N(3.94 lbs) | Mean = 9.24Ind Min = 7.54Ind Max = 12.98Unit: lb | Mean = 7.99Ind Min = 6.64Ind Max = 11.11Unit: lb | Different | ||
| FlammabilityPart 1610 | Class I | Class I | Class I | Class I | Same | ||
| Hydrostatic Head(cm)AATCC 127 | Body/SleeveInd Min-51.02Ind Max=82.86 | Body/SleeveInd Min-52.24Ind Max=101.22 | Body/Sleeve:Mean = 69Ind Min = 56Ind Max = 84 | Body/Sleeve:Mean = 72Ind Min = 53Ind Max = 80 | Similar | ||
| Water Impact (g)AATCC 42 | Body/Sleeve:Ind Min = 0.0Ind Max = 0.3 | Body/Sleeve:Ind Min = 0.0Ind Max = 0.3 | Body/Sleeve:Mean = 0.08Ind Min = 0.05Ind Max = 0.13 | Body/Sleeve:Mean = 0.08Ind Min = 0.04Ind Max = 0.13 | Similar | ||
| Liquid BarrierPerformanceClassificationProperties | Device was tested in accordance withANSI/AAMI PB70:2012 and meetsLevel 3 requirements for an isolationgown. The critical zone areas testedwere the the body and sleeve (samefabric), the sleeve seam, the shoulderseam, and binding material. | Device was tested in accordance withANSI/AAMI PB70:2012 and meetsLevel 3 requirements for an isolationgown. The critical zone areas testedwere the body and sleeve (samefabric), the sleeve seam, front belt ortie attachment, and the front seam armattachment using multiple lots. | Similar | ||||
| Biocompatibility | The test was done againstISO10993-5 and ISO10993-10. Theresult indicates the gown isnon-cytotoxic, and non-sensitizing andnegligibly irritating | Under the conditions of each study, theCardinal HealthTM Isolation gown isnon-cytotoxic, non-irritating, andnon-sensitizing per ISO 10993-1. | Same | ||||
| SterilizationModality | None (Non-sterile) | None (Non-sterile) | Same | ||||
| Seam Strength | Seam Strength: | Seam Strength: | Performance values not available inpredicate 510(k) submission | N/A | |||
| 58.18N | 65.27N | ||||||
| Seam StrengthUltimate | Seam StrengthUltimate | ||||||
| Elongation(%):51.04 | Elongation(%):32.63% | ||||||
| Lint and otherparticlesgeneration in thedry state | Lint and otherparticlesgeneration in thedry state[Material]Total linting:A: face 222B: face 152Average 187Coefficient oflinting:A: face 2.3B: face 2.2Average 2.3 | Lint and otherparticlesgeneration in thedry state[Material]Total linting:A: face 527B: face 641Average 584Coefficient oflinting:A: face 2.7B: face 2.8Average 2.8 | Performance values not available inpredicate 510(k) submission | N/A | |||
| Thermal andEvaporativeResistance | Evaporativeresistance(m2·kPa/W)[Material]:0.00217 | Evaporativeresistance(m2·kPa/W)[Material]:0.00198 | Performance values not available inpredicate 510(k) submission | N/A |
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Analvsis:
The subject isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength (both warp direction and filing direction) is slightly different from that of the predicate device. The tearing strength of the proposed device has been tested according to ASTM D5587-15 and met the requirement of the standard.
Under the conditions of each study, the subject isolation gown is non-cytotoxic, non-sensitizing and neeligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.
H. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
- ISO 10993-05:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity A
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin
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Sensitization
-
ASTM D5034-09 (2017), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
-
ASTM D5587-15 (2019), Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and > Drapes Intended For Use In Health Care Facilities
-
ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
ISO 9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
- A ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
I. Clinical Test Conclusion
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the subject Isolation Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160339.
§ 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.