(268 days)
The Disposable Surgical Isolation Gown is intended to protect 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 disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The provided text describes the acceptance criteria and study for a Disposable Surgical Isolation Gown, not an AI device. As such, information regarding AI-specific details like effect size improvement with AI assistance, standalone algorithm performance, or ground truth establishment for AI training sets is not present. Therefore, the response will focus on the details pertinent to the medical device described.
Acceptance Criteria and Device Performance for Disposable Surgical Isolation Gown
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Weight per square (g) (ASTM D3776) | ≥65g/m² | Lot A: 66.88 g/m²Lot B: 67.86 g/m²Lot C: 66.92g/m² | Pass |
| Flammability (16 CFR Part 1610) | Class 1: Burn time ≥ 3.5 seconds | Class 1 (Results obtained from Three Lots) | Pass |
| Liquid Barrier Performance (AATCC-127) - Hydrostatic Pressure | > 50 cm H₂O | > 50 cm H₂O (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (AATCC-42) - Water Impact | ≤ 1.0 g | ≤ 1.0 g (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (ASTM F1671/F1671M-2013) - Blood-Borne Pathogen | 1. Assay titer (PFU/mL) < 12. 29 out of 32 pass at 13.8 kPa (1 min) | 1. Base Material: Pass2. Seam: Pass3. Sleeve seam: PassAssay titer (PFU/mL): All were < 1 (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Tensile Strength (ASTM D5034) | ≥ 7 lbf | Lot A: (Length: 42.94 lbf / Width: 30.4 lbf)Lot B: (Length: 43.5 lbf / Width: 29.5 lbf)Lot C: (Length: 42.64 lbf / Width: 30.38 lbf) | Pass |
| Tearing Strength (ASTM D5733) | ≥ 2.3 lbf | Lot A: (Length: 18.82 lbf / Width: 12.2 lbf)Lot B: (Length: 19.94 lbf / Width: 12.98 lbf)Lot C: (Length: 20.32 lbf / Width: 12.3 lbf) | Pass |
| Seam Strength (ASTM D1683) | ≥ 7 lbf | Lot A: 22.14 lbf (FTS)Lot B: 20.6 lbf (FTS)Lot C: 21.4 lbf (FTS) | Pass |
| Linting (EN ISO 9073-10) | Log₁₀ < 4 | Log₁₀ < 4 (Material/Sleeve) (Results obtained from Three Lots) | Pass |
| Air permeability (ASTM D737) | -- (No specific numerical acceptance criterion listed, but "Pass" implies meeting expected performance) | 0.065 cm³/cm²/sec (Results obtained from Three Lots) | Pass |
| Evaporative Resistance of Clothing Materials (ASTM F1868) | -- (No specific numerical acceptance criterion listed, but "Pass" implies meeting expected performance) | Lot A: Evaporative Resistance: 0.08981 kPa.m²/W, Intrinsic: 0.08638 kPa.m²/WLot B: Evaporative Resistance: 0.08666 kPa.m²/W, Intrinsic: 0.08323 kPa.m²/WLot C: Evaporative Resistance: 0.08971 kPa.m²/W, Intrinsic: 0.08628 kPa.m²/W | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Noncytotoxic | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation (ISO 10993-10:2010) | Nonirritating | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization (ISO 10993-10:2010) | Nonsensitizing | Under the conditions of the study, the device is nonsensitizing. | Pass |
The reported device performance indicates that the Disposable Surgical Isolation Gown successfully met all stated acceptance criteria for the non-clinical tests conducted.
2. Sample size used for the test set and the data provenance:
- Sample Size: For liquid barrier performance tests (AATCC-127, AATCC-42, ASTM F1671/F1671M-2013), a sample size of 32 per lot was used. For other tests like Weight per square, Flammability, Tensile Strength, Tearing Strength, Seam Strength, Linting, Air Permeability, and Evaporative Resistance, three non-consecutive lots of the device were tested.
- Data Provenance: The document does not explicitly state the country of origin for the test data, nor does it specify if the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a physical medical device, the studies are typically conducted by the manufacturer or accredited labs to international and national standards, and are prospective in nature to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The "ground truth" for this type of medical device (surgical gown) is established through standardized non-clinical laboratory tests and objective measurements against predefined international and national standards (e.g., ASTM, AATCC, ISO, 16 CFR). There's no subjective expert interpretation of results that would require "ground truth" establishment in the context of diagnostic or imaging AI.
4. Adjudication method for the test set:
Not applicable. As noted above, the evaluation relies on objective, standardized laboratory test results, not on expert adjudication of subjective assessments.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used:
The "ground truth" for this device is established through adherence to standardized test methods and their specified acceptance criteria from organizations like ASTM, AATCC, ISO, and regulatory bodies (16 CFR). These standards define objective, measurable physical and biological properties.
8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The manufacturing process is validated through quality control and adherence to good manufacturing practices.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI device, there is no "training set" or corresponding ground truth establishment process in that context.
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April 29, 2022
Crown Name Disposable Hygiene Products Fty.Ltd. % Doris Chen Regulatory Affairs Staff Shanghai Jiushun Enterprise Management Technology Service Co Room 1502,BaoAn Buiding,No.800 Dongfang Road Shanghai, 200122 China
Re: K212422
Trade/Device Name: Disposable Surgical Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: March 28, 2022 Received: April 1, 2022
Dear Doris Chen:
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 Qian, M.D., Ph.D. Acting 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) K212422
Device Name Disposable Surgical Isolation Gown Model:CN302
Indications for Use (Describe)
The Disposable Surgical Isolation Gown is intended to protect 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 disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device 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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510(k) Summary K212422
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of 21 CFR 807.92.
The assigned 510(k) Number: K212422
Summary Prepared Date:March 28, 2022
Submitter Information 1.
- � Sponsor Name: Crown Name Disposable Hygiene Products Fty. Ltd.
- Address: Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District,Wuhan,Hubei, � 431400,CHINA.
- Contact Person (including title): Ying Fang (Manger) �
- � Phone:+86-27-82761940
- � Fax: +86-27-82761339
2. Submission Correspondent:
- Contact Person: Doris Chen �
- � Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
- � Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
- Tel: +86-21-50931939 �
- � Email: doris-chen@isosh.com
3. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical Apparel |
| Trade Name: | Disposable Surgical Isolation Gown |
| Classification Name: | Gown, Isolation, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FYC |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
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4. Predicate Device Information
Predicate Device
| Sponsor: | Yanbian Pacific Textile Co., LTD |
|---|---|
| Common Name: | Surgical Apparel |
| Trade Name: | Surgical Isolation Gown |
| 510(k) number: | K203415 |
| Review Panel: | General Hospital |
| Product Code: | FYC |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: |
Device Description 5.
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
6. Intended Use / Indications for Use
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not
Crown Name Disposable Hygiene Products Fty.Ltd.
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intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
Comparison with predicate device 7.
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Crown Name Disposable HygieneProducts Fty.Ltd. | Yanbian Pacific Textile Co.,LTD | -- |
| Product Name | Disposable Surgical Isolation Gown | Surgical Isolation Gown | -- |
| K Number | K212422 | K203415 | -- |
| Product Code | FYC | FYC | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use/Indications forUse | The Disposable Surgical IsolationGown is intended to protect patientsand health care personnel from thetransfer of microorganisms, bodyfluids and particulate material. Notintended for use in the operatingroom. In addition, the disposablesurgical isolation gown meets therequirements of a Level 4 barrierprotection per ANSI/AAMIPB70:2012 -Liquid BarrierPerformance and Classification ofProtective Apparel Drapes Intendedfor Use in Health Care Facilities.The disposable surgical isolationgown is a single use, disposablemedical device provided non-sterile. | The Surgical IsolationGown is intended to protectpatients and health carepersonnel from the transferof microorganisms, bodyfluids and particulatematerial. Not intended foruse in the operating room.In addition, the SurgicalIsolation Gown meets therequirements of an AAMILevel 3 barrier protectionfor an isolation gown perANSI/AAMI PB70:2012Liquid Barrier Performanceand Classification ofProtective Apparel DrapesIntended for Use in HealthCare Facilities (ANSI/AAMIPB70). The SurgicalIsolation Gown is a singleuse, disposable medicaldevice provided non-sterile | Similar |
| Barrierprotectionlevel | Level 4 per AAMI PB 70 | Level 3 per AAMI PB 70 | DifferentNote 1 |
| Gown Style | Hook and loop Closure,Belt Tie,Elastic Cuffs | Tape Neck Closure ,BeltTie,Elastic Cuffs | SimilarNote 3 |
| Durability | Disposable | Disposable | Same |
| OTC Use | Yes | Yes | Same |
| Sterile | No | No | Same |
| Size | S, M, L, XL, XXL, XXXL. | S, M, L, XL, XXL, 3XL, 4XL | Similar |
| Color | Blue | Blue | Same |
| MaterialComposition | SMS Nonwoven, Polyethylene,Polyester, Polypropylene, Nylon | SMS PP + PE non-wovenfabric material | SimilarNote 2 |
| Weight persquare (g)(ASTM D3776) | 66g/m² | 60.7g/m² (1.79 oz/yd2) | SimilarNote 3 |
| Flammability(16 CFR Part1610) | Class I(Results obtained from Three Lots) | Class I | Same |
| (Results obtained from Three Lots)Hydrostatic Pressure(cm):>50cm H2O(AATCC-127) | Hydrostatic Pressure(cm):>50cm H2O(AATCC-127) | Same | |
| Liquid Barrier | Water Impact (g): ≤1.0g(AATCC-42) | Water Impact (g): ≤1.0g(AATCC-42) | Same |
| Performance(AAMI PB70) | Resistance by Blood-BornePathogen:1: Base Material: Pass2:Seam:Pass3:Sleeve seam:PassAssay titer (PFU/mL):All were<1(ASTM F1671/F1671M-2013) | Unknown | DifferentNote 4 |
| BreakingStrength(ASTM D5034) | Lot A:(Length:191.46N/Width:135.46N)Lot B:(Length:193.88N/Width:131.52N)Lot C:(Length:190.76N/Width:135.48N) | Breaking Strength(MD):(Mean: 175.5N)Breaking Strength(CD):(Mean: 118.0N) | SimilarNote 4 |
| TearingStrength(ASTM D5733) | Lot A:(Length:83.92N/Width:54.42N)Lot B:(Length:89.02lbf/Width:57.96N) | Tearing strength (MD):Mean: 63.5NTearing strength (CD):Mean: 34.5N | SimilarNote 4 |
| Lot C:(Length:20.32lbf/Width:12.3lbf) | |||
| Linting(EN ISO9073-10) | Lot A:1.Material(Mean):2.6(Face A/B)2.Sleeve seam(Mean):2.6(FaceA/B)Lot B:1.Material(Mean):2.9(Face A/B)2.Sleeve seam(Mean):3.0(FaceA/B)Lot C:1.Material(Mean):2.9(Face A/B)2.Sleeve seam(Mean):2.9(FaceA/B)( $Log_{10}$ <4)(Results obtained from Three Lots) | Particulate size range(µm):3 to 25A: Face: Measured valueCoefficient of lingting log10Min:2.2, Max:2.8,Mean: 2.5;B: Face: Measured valueCoefficient of lingting log10Min:2.5, Max:2.9,Mean:2.74 | SimilarNote 4 |
| Seam Strength(ASTM D1683) | Lot A: 22.14lbf(FTS)Lot B: 20.6lbf(FTS)Lot C:21.4lbf(FTS) | Unknown | DifferentNote 5 |
| Airpermeability(ASTM D737) | 0.065cm³/cm²/sec(Results obtained from Three Lots) | Unknown | DifferentNote 5 |
| Thermal andEvaporativeResistance(ASTM F1868) | Evaporative Resistance:Arithmetic Mean:0.089kPa.m²/WIntrinsic EvaporativeArithmetic Mean:0.085kPa.m²/W | Unknown | DifferentNote 5 |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study,the device is noncytotoxic. | Under the conditions of thestudy, the device isnoncytotoxic. | Same |
| Sensitization | Under the conditions of the study,the device is nonsensitizing | Under the conditions of thestudy, the device isnonsensitizing | Same |
| Irritation | Under the conditions of the study,the device is nonirritating. | Under the conditions of thestudy, the device isnonirritating. | Same |
Table 1 General Comparison
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Note: "unknown" above indicates performance values were not available in predicate 510(k) submissions.
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Note 1
The barrier protection level of the subject device is different from the predicate device,but the test results of they are both meet the requirement of surgical isolation gown's barrier protection level according to the AAMI PB70.Therefore, this different will not raise new safety and effectiveness questions.
Note 2
The material of the subject device is different from the predicate device. There are not raise additional questions for safety and effectiveness.
The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements. There is no new risk generated from the difference of the material.
Note 3
Compare with the subject device and predicate device, the different of the physical feature(Weight Per Unit Area,Gown style) does not affect the intended use of the subject device. Therefore, this different will not raise new safety and effectiveness questions.
Note 4
For the performance testing of liquid barrier performance,breaking strength,tearing strength, seam strength and linting level,the test results of the subject device and the predicate device are not identical to each other, but they are similar and both meet the requirements of the acceptance standards of their corresponding performance testing standards.Therefore, this different will not raise new safety and effectiveness questions.
Note 5
Although the seam strength,air permeability, thermal and evaporative resistance of the predicate devices are unknown, the seam strength,air permeability,thermal and evaporative resistance of the subject device all meet the corresponding standard requirements and can be used safely. Therefore, this different will not raise new safety and effectiveness questions.
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8. Summary of Non-Clinical Tests Performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications as to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes:
- A ASTM- F2407-20 Standard Specification for Surgical Gowns intended for Use in Healthcare Facilities
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.
-
ASTM F1671/F1671M-2013 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne.
-
AATCC 42-2017e-Water Penetration Resistance:Impact Penetration Test.
-
AATCC 127-2017(2018)-Water Resistance:Hydrostatic Pressure Test.
-
ISO 9073-10:2004 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State.
- A ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics.
-
ASTM D5733:1999 Standard Test Method For Tearing Strength of Nonwoven Fabrics By The Trapezoid Procedure.
-
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).
-
ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics.
-
ASTM D3776/D3776M-09a(2017) Basis Weight-Mass Per Unit Area (Weight) of Fabric.
-
ASTM F1868–17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate.
-
ISO 10993-5:2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
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| Test item | Proposed device | Acceptance criteria | Results |
|---|---|---|---|
| Weight persquare (g)(ASTM D3776) | 3 non-consecutive lots testedLot A: 66.88 g/m²Lot B: 67.86 g/m²Lot C: 66.92g/m² | ≥65g/m² | Pass |
| Flammability(16 CFR Part 1610) | Class13 non-consecutive lots tested | Class 1:Burntime≥3.5seconds | Pass |
| Liguid BarrierPerformanceAATCC-127 | 3 non-consecutive lots tested, using asample size of 32/lot.Hydrostatic Pressure(cm) :>50cm H2O | HydrostaticPressure(cm) :>50cm H2O | Pass |
| Liguid BarrierPerformance(AATCC-42) | 3 non-consecutive lots tested, using asample size of 32/lot.Water Impact (g): ≤1.0g | Water Impact(g): ≤1.0g | Pass |
| Liguid BarrierPerformance(ASTMF1671/F1671M-2013) | 3 non-consecutive lots tested, using asample size of 32/lot.Resistance t by Blood-BornePathogen:1: Base Material: Pass2:Seam:Pass3:Sleeve seam:PassAssay titer (PFU/mL):All were<1 | 1.Assay titer(PFU/mL)<12.29 out of 32pass at13.8kPa(1min) | Pass |
| Tensile Strength(ASTM D5034) | Lot A: (Length:42.94Ibf/Width:30.4Ibf)Lot B: (Length:43.5lbf/Width:29.5lbf)Lot C:(Length:42.64lbf/Width:30.38lbf) | ≥7lbf | Pass |
| Tearing Strength(ASTM D5733) | Lot A: (Length:18.82lbf/Width:12.2lbf)Lot B:(Length:19.94lbf/Width:12.98lbf)Lot C:(Length:20.32lbf/Width:12.3lbf) | ≥2.3 lbf | Pass |
| Seam Strength(ASTM D1683) | Lot A: 22.14lbf(FTS)Lot B: 20.6lbf(FTS)Lot C:21.4lbf(FTS) | ≥7 lbf | Pass |
| Linting(EN ISO 9073-10) | Log10<4(Material/Sleeve)(Results obtained from Three Lots) | Log10<4 | Pass |
| Air permeability(ASTM D737) | 0.065cm³/cm²/sec(Results obtained from Three Lots) | -- | Pass |
| Evaporative Resistanceof Clothing Materials(ASTM F1868) | Lot A:Evaporative Resistance:Arithmetic Mean:0.08981kPa.m2/WIntrinsic Evaporative ArithmeticMean:0.08638kPa.m2/W | -- | |
| Lot B:Evaporative Resistance (Ret)Arithmetic Mean:0.08666kPa.m2/W"Intrinsic Evaporative ArithmeticMean:0.08323kPa.m2/W" | |||
| Lot C:Evaporative Resistance (Ret)Arithmetic Mean:0.08971kPa.m2/W"Intrinsic Evaporative ArithmeticMean:0.08628kPa.m2/W" | Pass | ||
Table 2:Performance Testing
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Results:All tests were passed.
Biocompatibility evaluation and test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and
ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- A In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- 》 Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices
—Part 10: Tests for irritation and skin sensitization
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices—
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device isnoncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device isnonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device isnonsensitizing | Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
{12}------------------------------------------------
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device,
Disposable Surgical Isolation Gown is as safe, as effective, and performs as well as or better
than the legally marketed predicate device, Surgical Isolation Gown(K203415).
§ 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.