(175 days)
The Surgical Isolation Gown is 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 Surgical Isolation Gown meets 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 Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).
The Surgical Isolation Gown 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 requirement.
The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria (Requirement) | Reported Device Performance (Average, 32 samples/lot) |
|---|---|---|
| Flammability (16 CFR Part 1610-2008) | Class I | Lot1: Class I, Lot2: Class I, Lot3: Class I |
| Hydrostatic Pressure (AATCC 127) | Level 3: >50 cmH2O | Lot1: Front: 151.6, Back: 142.8, Sleeve: 148.5, Sleeve seam: 149.8, Shoulder seam: 155.3, Waistband seam: 99.5Lot2: Front: 165.4, Back: 158.4, Sleeve: 153.4, Sleeve seam: 133.5, Shoulder seam: 141.2, Waistband seam: 59.1Lot3: Front: 163.7, Back: 154.4, Sleeve: 153.9, Sleeve seam: 130.7, Shoulder seam: 143.2, Waistband seam: 58.3 |
| Impact Penetration (AATCC 42) | Level 3: <1.0 g | Front: <0.2, Back: <0.1, Sleeve: 0, Sleeve seam: 0, Shoulder seam: <0.1, Waistband seam: <0.1 |
| Tensile Strength (MD) (ASTM D5034) | ≥30N | Lot1: 135N, Lot2: 134N, Lot3: 133N |
| Tensile Strength (CD) (ASTM D5034) | ≥30N | Lot1: 82N, Lot2: 80N, Lot3: 78N |
| Tearing Strength (MD) (ASTM D5733) | ≥10N | Lot1: 39N, Lot2: 39N, Lot3: 40N |
| Tearing Strength (CD) (ASTM D5733) | ≥10N | Lot1: 22N, Lot2: 20N, Lot3: 20N |
| Sleeve Seam Strength (ASTM D1683/D 1683M-17) | ≥30N | Lot1: 60N, Lot2: 63N, Lot3: 73N |
| Armhole Seam Strength (ASTM D1683/D 1683M-17) | ≥30N | Lot1: 64N, Lot2: 69N, Lot3: 62N |
| Shoulder Seam Strength (ASTM D1683/D 1683M-17) | ≥30N | Lot1: 63N, Lot2: 63N, Lot3: 61N |
| Total Linting (ISO 9073-10) | Not explicitly stated/Compared to predicate's better result | Side A: Lot1: 61, Lot2: 55, Lot3: 66Side B: Lot1: 200, Lot2: 146, Lot3: 115 (Better than K171535) |
| Coefficient of Linting (ISO 9073-10) | Not explicitly stated | Side A: Lot1: 1.8, Lot2: 1.7, Lot3: 1.8Side B: Lot1: 2.2, Lot2: 2.1, Lot3: 2.0 |
| Evaporative Resistance (ASTM F1868-17) | >1.00 kPa·m²/W | Lot1: >1.0 kPa·m²/W, Lot2: >1.0 kPa·m²/W, Lot3: >1.0 kPa·m²/W |
| Cytotoxicity (EN ISO10993-5) | Non-Cytotoxic | PASS (non-Cytotoxic) |
| Irritation (EN ISO 10993-10) | Non-Irritating | PASS (non-Irritating) |
| Sensitization (EN ISO 10993-10) | Non-Sensitizing | PASS (non-Sensitizing) |
2. Sample size used for the test set and the data provenance
The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).
4. Adjudication method for the test set
Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.
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 document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:
- Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
- Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).
8. The sample size for the training set
Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
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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 - USA 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.
January 20, 2022
Wuhan Zonsen Medical Products Co., Ltd Cynthia Ye General Manager No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, Hubei 431000 China
Re: K212357
Trade/Device Name: Surgical isolation gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: November 16, 2021 Received: December 21, 2021
Dear Cynthia Ye:
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 medical devices and radiation-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) K212357
Device Name Surgical Isolation Gown
Indications for Use (Describe)
The Surgical Isolation Gown is 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 Surgical Isolation Gown meets 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 Drapes Intended for Use in Health Care Facilities. The 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
510(k) Number: K212357 Revised date: January 17, 2022 A. Applicant: Wuhan Zonsen Medical Products Co., Ltd Address: No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei Contact Person: Cynthia Ye Tel: +86-27-82737771 Fax: +86- 27-82737772
Submission Correspondent: Primary contact: Cynthia Ye Tel: +86-27-82737771 Email: info@zonsenmed.com Secondary contact: Cynthia Ye Tel: +86-27-82737772 Email:Cynthia@zonsenmed.com
B. Device:
Trade Name: SURGICAL ISOLATION GOWN Common Name: ISOLATION GOWN Model(s): ZIG 1256
Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K190306 AMD Ritmed AssureWear™ VersaGown AMD Medicom, Inc.
D. Reference device:
K171535 Surgical Isolation Gown Jingzhou Haixin Green Cross Medical Products Co., Ltd
E. Indications for use :
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei
The Surgical Isolation Gown is 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 Surgical Isolation Gown meets 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 Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
F. Device Description:
The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).
The Surgical Isolation Gown 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 requirement.
| ComparisonComponent | Proposed Device | Predicate Device | Reference Device | Comparison | |
|---|---|---|---|---|---|
| Manufacturer | Wuhan Zonsen MedicalProducts Co., Ltd | AMD Medicom, Inc. | Jingzhou Haixin GreenCross MedicalProducts Co., Ltd | / | |
| 510K number | K212357 | K190306 | K171535 | / | |
| Device name | Surgical isolation gown | AMDRitmedAssureWear™ VersaGown | SURGICALISOLATION GOWN | / | |
| Classification | Class II Device, FYC (21CFR878.4040) | Class II Device, FYC (21CFR878.4040) | Class II Device, FYC(21CFR878.4040) | Same | |
| Intend use /Indicationsfor use | The Surgical IsolationGown is intended toprotect health care patientsand health care personnelfrom the transfer ofmicroorganisms, bodyfluids and particulatematerial. Not intended foruse in the operating room.In addition, the SurgicalIsolation Gown meets therequirements of an AAMI | AMDRitmedAssureWear™ VersaGownis intended to be worn byhealthcare personnel toprotect health care patientsand health care personnelfrom the transfer ofmicroorganisms, bodyfluids and particulatematerial. AMD RitmedAssureWear™ VersaGownis a single use, disposable | The Surgical IsolationGown is intended toprotect health carepatients and health carepersonnel from thetransfer ofmicroorganisms, bodyfluids and particulatematerial. Not intendedfor use in the operatingroom. In addition, theSurgical Isolation Gown | Same | |
| Level 3 barrier protectionfor an isolation gown perANSI/AAMI PB70:2012Liquid BarrierPerformanceandClassification of ProtectiveApparel Drapes Intendedfor Use in Health CareFacilities. The SurgicalIsolation Gown is a singleuse, disposable medicaldevice providednon-sterile. | medical device providednon-sterileandnon-intended for use inoperating rooms. | meets the requirementsof an AAMI Level 3barrier protection for anisolation gown perANSI/AAMI PB70:2012Liquid BarrierPerformance andClassification ofProtective ApparelDrapes Intended for Usein Health Care Facilities(ANSI/AAMI PB70).The Surgical IsolationGown is a single use,disposable medicaldevice providednon-sterile. | |||
| LevelofbarrierprotectionAAMI PB70 | Level 3 | Level 3 | Level 3 | Same | |
| Materialcomposition | Polypropylenenon-woven + PE | SMS | PP SMS non-woven + PE | Polypropylene SMS nonwoven | Same asK190306 |
| Design | Elastic cuffsTie (neck)Blue waist beltReinforced seams | Thumb loopElastic cuffsExtended cuff(Thumb loop)Flexneck™Tie (neck)Straight sleeveInclined sleeveBlue belt tieReinforced seams | Medical Tape NeckClosureWhite Belt TieSnap fastener | Similar toK190306 | |
| Color | Blue | Blue | Yellow | Same asK190306 | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single use; disposable | Single use; disposable | Single use; disposable | Same |
G. Comparison with predicate device
Table1
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei
Table 2
| Non-clinical Performance | |||||
|---|---|---|---|---|---|
| Comparison Component | Proposed Device (K212357) | Predicate Device (K190306) | Reference Device (K171535) | Comparison | |
| Basic weight ASTM D3776 | $40\pm2$ g/m² | $39.97\pm1.61$ g/m² | Testing not | Similar | |
| Non-clinical Performance | |||||
| Comparison Component | Proposed Device(K212357) | Predicate Device(K190306)(1.17 oz/yd² ± 0.05) | Reference Device(K171535)performed | ComparisontoK190306 | |
| Liquid barrierperformance | AATCC 127HydrostaticPressure( cmH2O ) | Average:Front: 160.29*Back: 152.09*Sleeve: 152.03*Sleeve seam:138.06*Shoulder seam:146.50*Waistband seam:72.19* | Chest:109.34 ± 0.34Sleeve seams:110.67± 3.84Belt attachments:104 ± 5.19Body/sleeve/beltmean: 108 ±3.1 | CHEST/BACK/SLEEVE:Mean = 69Ind Min = 54Ind Max = 84 | SimilartoK190306 |
| AATCC 42ImpactPenetration( g ) | Front: <0.2Back: <0.1Sleeve: 0Sleeve seam: 0Shoulder seam: <0.1Waistbandseam:<0.1 | Chest: <0.1Sleeve seams: <0.1Belt attachments: <0.1Body/sleeve/beltmean: <0.1 | Sleeve Seams:Mean = 0.04Ind Min = 0.02Ind Max = 0.08CHEST:Mean = 0.04Ind Min = 0.02Ind Max = 0.05Back:Mean = 0.05Ind Min = 0.04Ind Max = 0.07 | Similar | |
| Flammability16 CFR Part1610-2008 | Class I | Class I | Class I | Same | |
| Tensile strength (MD) ASTMD5034 | 134N* | 18.17 ± 0.31 lbf | Mean = 20.71 lbfInd Min = 19.73Ind Max = 21.87 | Similar | |
| Tensile strength (CD) ASTMD5034 | 80N* | 11.78 ± 0.33 lbf | Mean = 12.21 lbfInd Min = 11.20Ind Max = 14.11 | Similar | |
| Tearing strength (MD) ASTMD5733 | 39N* | 11.01 ± 0.64 lbf | Mean = 3.48 lbfInd Min = 2.82Ind Max = 3.93 | Similar | |
| Tearing strength (CD) ASTMD5733 | 21N* | 5.30 ± 0.35 lbf | Mean = 7.15 lbfInd Min = 6.20Ind Max = 7.70 | Similar | |
| Seam strengthASTM 1683/D | Sleeve seamArmhole seam | 65N*65N* | Testing notperformed | Testing notperformed | / |
| Non-clinical Performance | |||||
| Comparison Component | Proposed Device(K212357) | Predicate Device(K190306) | Reference Device(K171535) | Comparison | |
| 1683M-17(2018) | Shoulder seam | 62N* | |||
| Linting (ISO 9073-10) | Particulate size range(µm):3 to 25Side A: Total linting:61*; Coefficient oflinting: 1.8*Side B: Total linting:154*; Coefficient oflinting: 2.1* | Particulate size range(µm): 1 to 25Outside:Total linting >0.3 :2.07; >0.5 : 1.97Index for ParticulateMatter (IPM): 1.50Inside:Total linting >0.3 :2.16; >0.5 : 2.00Index for ParticulateMatter (IPM): 1.35 | SIDE A:OUTSIDETOTAL >0.31024TOTAL >0.5658SIDE B: INSIDETOTAL >0.31066TOTAL >0.5697 | BetterthanK171535 | |
| ASTM F1868-17 EvaporativeResistance | >1.00 kPa.m²/W | Testing notperformed | Testing notperformed | / | |
| Biocompatibility | Irritation ISO10993-10 | Under the conditionof the study, nonirritating | Under the conditionof the study, not anirritant | The test was doneagainstISO10993-5 andISO10993-10. The | Same |
| SensitizationISO 10993-10 | Under the conditionof the study, nonsensitizing | Under the conditionof the study, not asensitizer | result indicates thegown is | Same | |
| CytotoxicityISO 10993-5 | Under the conditionof the study, non-cytotoxic | Under the conditionof the study, non-cytotoxic | noncytotoxic,non-irritating, andnon-sensitizing perISO 10993-1 | Same |
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Note: * means the average results of 3 non-consecutive lots,32 samples/ lot.
H. Summary of Non-Clinical Test
The Surgical Isolation gowns were tested following below standards:
- ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity; A
- A ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
-
ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities;
- AATCC 42 Water Penetration Resistance: Impact Penetration Test; A
- AATCC 127 Water Resistance: Hydrostatic Pressure Test; >
- ASTM D5034-09 (Reapproved 2017) Test Method for Breaking Strength and Elongation of A Textile Fabrics (Grab Test) ;
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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei
- A ASTM D5733-99 Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure;
- A ASTM D1683/ D 1683M-17(2018) Test methods for Failure in Sewn Seams of Woven Apparel Fabrics;
-
16 CFR 1610-2008 Standard for the Flammability of clothing textiles;
- A ISO9073-10:2003 Textiles-Test methods for nonwovens-Part 10: Lint and other particles generation in the dry state;
- A ASTM F1868-17 Test methods for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate.
| Test Item | Requirement | Test results (Average, 32 samples/ lot) | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Flammability 16 CFR Part1610-2008 | Class I | Lot1: Class ILot2: Class ILot2: Class I | ||||||||||||||||||||||||||||
| AATCC 127 Hydrostatic Pressure(cmH2O) | Level 3: >50 | Lot1 Lot2 Lot3 Front 151.6 165.4 163.7 Back 142.8 158.4 154.4 Sleeve 148.5 153.4 153.9 Sleeve seam 149.8 133.5 130.7 Shoulder seam 155.3 141.2 143.2 Waistband d seam 99.5 59.1 58.3 | ||||||||||||||||||||||||||||
| AATCC 42 Impact Penetration(g) | Level 3:<1.0 | Front: <0.2Back: <0.1Sleeve: 0Sleeve seam: 0Shoulder seam: <0.1Waistband seam: <0.1 | ||||||||||||||||||||||||||||
| Tensile StrengthASTM D5034 | MD | ≥30NLot1: 135NLot2: 134NLot3: 133N | ||||||||||||||||||||||||||||
| CD | ≥30NLot1: 82NLot2: 80NLot3: 78N | |||||||||||||||||||||||||||||
| Tearing StrengthASTM D5733 | MD | ≥10NLot1: 39NLot2: 39NLot3: 40N |
Table 3 - Performance Testing
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| Wuhan Zonsen Medical Products Co., Ltd |
|---|
| No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei |
| Seam Strength ASTMD1683/D1683M-17(2018) | CD | ≥10N | Lot1: 22N | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lot2: 20N | ||||||||||||||||
| Lot3: 20N | ||||||||||||||||
| Sleeve seam | ≥30N | Lot1: 60N | ||||||||||||||
| Lot2: 63N | ||||||||||||||||
| Lot3: 73N | ||||||||||||||||
| Armhole seam | Lot1: 64N | |||||||||||||||
| Lot2: 69N | ||||||||||||||||
| Lot3: 62N | ||||||||||||||||
| Shoulder seam | Lot1: 63N | |||||||||||||||
| Lot2: 63N | ||||||||||||||||
| Lot3: 61N | ||||||||||||||||
| Linting (ISO 9073-10)Size of particlescounted:3µm ~ 25µm | Total linting | / | Side A Side B Lot1 61 200 Lot2 55 146 Lot3 66 115 | |||||||||||||
| Coefficient of linting | / | Side A Side B Lot1 1.8 2.2 Lot2 1.7 2.1 Lot3 1.8 2.0 | ||||||||||||||
| ASTM F1868-17Resistance | Evaporative | / | Lot1: >1.0 kPa·m2 /WLot2: >1.0 kPa·m2 /WLot3: >1.0 kPa·m2 /W |
Table 4 -Biological Specifications:
| Performance | Requirement | Results |
|---|---|---|
| CytotoxicityEN ISO10993-5 | Non-Cytotoxic | PASSPer the Biocompatibility Evaluation, the proposed deviceis non-Cytotoxic. |
| IrritationEN ISO 10993-10 | Non-Irritating | PASSPer the Biocompatibility Evaluation, the proposed deviceis non-Irritating. |
| SensitizationEN ISO 10993-10 | Non-Sensitizing | PASSPer the Biocompatibility Evaluation, the proposed deviceis non-Sensitizing. |
All the test results meet the requirement of ASTM F2407-20 Standard Specification For Surgical Gowns Intended for Use in Healthcare Facilities, and meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and
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Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities.
I. Clinical Performance
Not applicable.
J. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device identified.
§ 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.