Surgical isolation gown
Device Facts
| Record ID | K212357 |
|---|---|
| Device Name | Surgical isolation gown |
| Applicant | Wuhan Zonsen Medical Products Co., Ltd. |
| Product Code | FYC · General, Plastic Surgery |
| Decision Date | Jan 20, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Surgical isolation gown (Model ZIG 1256) provides moderate barrier protection; intended for healthcare personnel and patient protection against microorganisms, body fluids, and particulates. Constructed from Polypropylene SMS non-woven fabric coated with Polyethylene; features neck tie, waist belt, and elastic cuffs; seams reinforced with 100% Polyurethane sealing tape. Single-use, disposable, non-sterile device. Used in clinical settings (excluding operating rooms). Protects users by acting as a physical barrier; performance validated against AAMI Level 3 requirements (ANSI/AAMI PB70:2012).
Clinical Evidence
No clinical data. Bench testing only. Performance validated per ANSI/AAMI PB70:2012 (hydrostatic pressure, impact penetration), ASTM D5034 (tensile strength), ASTM D5733 (tearing strength), ASTM D1683 (seam strength), ISO 9073-10 (linting), and 16 CFR 1610 (flammability). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Technological Characteristics
Materials: Polypropylene SMS non-woven coated with Polyethylene; 100% Polyurethane seam sealing tape. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Form factor: Seven sizes (S-4XL) with neck tie, waist belt, elastic cuffs. Sterility: Non-sterile. Standards: ASTM D3776 (weight), ASTM D5034 (tensile), ASTM D5733 (tearing), ASTM D1683 (seam strength), ISO 9073-10 (linting), 16 CFR 1610 (flammability).
Indications for Use
Indicated for healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulate material. Not for use in operating rooms. Meets AAMI Level 3 barrier protection standards.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- AMD Ritmed AssureWear™ VersaGown (K190306)
Reference Devices
- Surgical Isolation Gown (K171535)
Related Devices
- K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) · Allmed Medical (Hubei) Protective Products Co., Ltd. · Aug 12, 2022
- K171535 — SURGICAL ISOLATION GOWN · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 15, 2018
- K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3) · Primed Medical Products, Inc. · Nov 4, 2016
- K212717 — Paneffort AAMI Level 3 Isolation Gown · Paneffort, LLC · Nov 30, 2022
- K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) · Owens & Minor (O&M) Halyard, Inc. · May 16, 2024
Submission Summary (Full Text)
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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.
| Comparison<br>Component | Proposed Device | Predicate Device | Reference Device | Comparis<br>on | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------|
| Manufacturer | Wuhan Zonsen Medical<br>Products Co., Ltd | AMD Medicom, Inc. | Jingzhou Haixin Green<br>Cross Medical<br>Products Co., Ltd | / | |
| 510K number | K212357 | K190306 | K171535 | / | |
| Device name | Surgical isolation gown | AMD<br>Ritmed<br>AssureWear™ VersaGown | SURGICAL<br>ISOLATION GOWN | / | |
| Classification | Class II Device, FYC (21<br>CFR878.4040) | Class II Device, FYC (21<br>CFR878.4040) | Class II Device, FYC<br>(21CFR878.4040) | Same | |
| Intend use /<br>Indications<br>for use | The Surgical Isolation<br>Gown is intended to<br>protect health care patients<br>and health care personnel<br>from the transfer of<br>microorganisms, body<br>fluids and particulate<br>material. Not intended for<br>use in the operating room.<br>In addition, the Surgical<br>Isolation Gown meets the<br>requirements of an AAMI | AMD<br>Ritmed<br>AssureWear™ VersaGown<br>is intended to be worn by<br>healthcare personnel to<br>protect health care patients<br>and health care personnel<br>from the transfer of<br>microorganisms, body<br>fluids and particulate<br>material. AMD Ritmed<br>AssureWear™ VersaGown<br>is a single use, disposable | The Surgical Isolation<br>Gown is intended to<br>protect health care<br>patients and health care<br>personnel from the<br>transfer of<br>microorganisms, body<br>fluids and particulate<br>material. Not intended<br>for use in the operating<br>room. In addition, the<br>Surgical Isolation Gown | Same | |
| | | | | | |
| | Level 3 barrier protection<br>for an isolation gown per<br>ANSI/AAMI PB70:2012<br>Liquid Barrier<br>Performance<br>and<br>Classification of Protective<br>Apparel Drapes Intended<br>for Use in Health Care<br>Facilities. The Surgical<br>Isolation Gown is a single<br>use, disposable medical<br>device provided<br>non-sterile. | medical device provided<br>non-sterile<br>and<br>non-intended for use in<br>operating rooms. | meets the requirements<br>of an AAMI Level 3<br>barrier protection for an<br>isolation gown per<br>ANSI/AAMI PB70:2012<br>Liquid Barrier<br>Performance and<br>Classification of<br>Protective Apparel<br>Drapes Intended for Use<br>in Health Care Facilities<br>(ANSI/AAMI PB70).<br>The Surgical Isolation<br>Gown is a single use,<br>disposable medical<br>device provided<br>non-sterile. | | |
| Level<br>of<br>barrier<br>protection<br>AAMI PB70 | Level 3 | Level 3 | Level 3 | Same | |
| Material<br>composition | Polypropylene<br>non-woven + PE | SMS | PP SMS non-woven + PE | Polypropylene SMS non<br>woven | Same as<br>K190306 |
| Design | Elastic cuffs<br>Tie (neck)<br>Blue waist belt<br>Reinforced seams | Thumb loop<br>Elastic cuffs<br>Extended cuff<br>(Thumb loop)<br>Flexneck™<br>Tie (neck)<br>Straight sleeve<br>Inclined sleeve<br>Blue belt tie<br>Reinforced seams | Medical Tape Neck<br>Closure<br>White Belt Tie<br>Snap fastener | Similar to<br>K190306 | |
| Color | Blue | Blue | Yellow | Same as<br>K190306 | |
| 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<br>(K212357) | Predicate Device<br>(K190306)<br>(1.17 oz/yd² ± 0.05) | Reference Device<br>(K171535)<br>performed | Comparison<br>to<br>K190306 | |
| Liquid barrier<br>performance | AATCC 127<br>Hydrostatic<br>Pressure<br>( cmH2O ) | Average:<br>Front: 160.29*<br>Back: 152.09*<br>Sleeve: 152.03*<br>Sleeve seam:<br>138.06*<br>Shoulder seam:<br>146.50*<br>Waistband seam:<br>72.19* | Chest:<br>109.34 ± 0.34<br>Sleeve seams:<br>110.67± 3.84<br>Belt attachments:<br>104 ± 5.19<br>Body/sleeve/belt<br>mean: 108 ±3.1 | CHEST/BACK/S<br>LEEVE:<br>Mean = 69<br>Ind Min = 54<br>Ind Max = 84 | Similar<br>to<br>K190306 |
| | AATCC 42<br>Impact<br>Penetration<br>( g ) | Front: <0.2<br>Back: <0.1<br>Sleeve: 0<br>Sleeve seam: 0<br>Shoulder seam: <0.1<br>Waistband<br>seam:<br><0.1 | Chest: <0.1<br>Sleeve seams: <0.1<br>Belt attachments: <<br>0.1<br>Body/sleeve/belt<br>mean: <0.1 | Sleeve Seams:<br>Mean = 0.04<br>Ind Min = 0.02<br>Ind Max = 0.08<br>CHEST:<br>Mean = 0.04<br>Ind Min = 0.02<br>Ind Max = 0.05<br>Back:<br>Mean = 0.05<br>Ind Min = 0.04<br>Ind Max = 0.07 | Similar |
| Flammability<br>16 CFR Part<br>1610-2008 | Class I | Class I | Class I | Same | |
| Tensile strength (MD) ASTM<br>D5034 | 134N* | 18.17 ± 0.31 lbf | Mean = 20.71 lbf<br>Ind Min = 19.73<br>Ind Max = 21.87 | Similar | |
| Tensile strength (CD) ASTM<br>D5034 | 80N* | 11.78 ± 0.33 lbf | Mean = 12.21 lbf<br>Ind Min = 11.20<br>Ind Max = 14.11 | Similar | |
| Tearing strength (MD) ASTM<br>D5733 | 39N* | 11.01 ± 0.64 lbf | Mean = 3.48 lbf<br>Ind Min = 2.82<br>Ind Max = 3.93 | Similar | |
| Tearing strength (CD) ASTM<br>D5733 | 21N* | 5.30 ± 0.35 lbf | Mean = 7.15 lbf<br>Ind Min = 6.20<br>Ind Max = 7.70 | Similar | |
| Seam strength<br>ASTM 1683/D | Sleeve seam<br>Armhole seam | 65N*<br>65N* | Testing not<br>performed | Testing not<br>performed | / |
| Non-clinical Performance | | | | | |
| Comparison Component | | Proposed Device<br>(K212357) | Predicate Device<br>(K190306) | Reference Device<br>(K171535) | Comparison |
| | | | | | |
| 1683M-17<br>(2018) | Shoulder seam | 62N* | | | |
| Linting (ISO 9073-10) | | Particulate size range(µm):<br>3 to 25<br>Side A: Total linting:<br>61*; Coefficient of<br>linting: 1.8*<br>Side B: Total linting:<br>154*; Coefficient of<br>linting: 2.1* | Particulate size range(µm): 1 to 25<br>Outside:<br>Total linting >0.3 :<br>2.07; >0.5 : 1.97<br>Index for Particulate<br>Matter (IPM): 1.50<br>Inside:<br>Total linting >0.3 :<br>2.16; >0.5 : 2.00<br>Index for Particulate<br>Matter (IPM): 1.35 | SIDE A:<br>OUTSIDE<br>TOTAL >0.3<br>1024<br>TOTAL >0.5<br>658<br>SIDE B: INSIDE<br>TOTAL >0.3<br>1066<br>TOTAL >0.5<br>697 | Better<br>than<br>K171535 |
| ASTM F1868-17 Evaporative<br>Resistance | | >1.00 kPa.m²/W | Testing not<br>performed | Testing not<br>performed | / |
| Biocompatibility | Irritation ISO<br>10993-10 | Under the condition<br>of the study, non<br>irritating | Under the condition<br>of the study, not an<br>irritant | The test was done<br>against<br>ISO10993-5 and<br>ISO10993-10. The | Same |
| | Sensitization<br>ISO 10993-10 | Under the condition<br>of the study, non<br>sensitizing | Under the condition<br>of the study, not a<br>sensitizer | result indicates the<br>gown is | Same |
| | Cytotoxicity<br>ISO 10993-5 | Under the condition<br>of the study, non-<br>cytotoxic | Under the condition<br>of the study, non-<br>cytotoxic | noncytotoxic,<br>non-irritating, and<br>non-sensitizing per<br>ISO 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 Part<br>1610-2008 | Class I | Lot1: Class I<br>Lot2: Class I<br>Lot2: Class I | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| AATCC 127 Hydrostatic Pressure<br>(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<br>(g) | Level 3:<1.0 | Front: <0.2<br>Back: <0.1<br>Sleeve: 0<br>Sleeve seam: 0<br>Shoulder seam: <0.1<br>Waistband seam: <0.1 | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Tensile Strength<br>ASTM D5034 | MD | ≥30N<br>Lot1: 135N<br>Lot2: 134N<br>Lot3: 133N | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | CD | ≥30N<br>Lot1: 82N<br>Lot2: 80N<br>Lot3: 78N | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Tearing Strength<br>ASTM D5733 | MD | ≥10N<br>Lot1: 39N<br>Lot2: 39N<br>Lot3: 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 ASTM<br>D1683/D<br>1683M-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)<br>Size of particles<br>counted: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 F1868-17<br>Resistance | Evaporative | / | Lot1: >1.0 kPa·m2 /W<br>Lot2: >1.0 kPa·m2 /W<br>Lot3: >1.0 kPa·m2 /W | | | | | | | | | | | |
Table 4 -Biological Specifications:
| Performance | Requirement | Results |
|----------------------------------|-----------------|-----------------------------------------------------------------------------------------|
| Cytotoxicity<br>EN ISO10993-5 | Non-Cytotoxic | PASS<br>Per the Biocompatibility Evaluation, the proposed device<br>is non-Cytotoxic. |
| Irritation<br>EN ISO 10993-10 | Non-Irritating | PASS<br>Per the Biocompatibility Evaluation, the proposed device<br>is non-Irritating. |
| Sensitization<br>EN ISO 10993-10 | Non-Sensitizing | PASS<br>Per the Biocompatibility Evaluation, the proposed device<br>is 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
{10}------------------------------------------------
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.
