(285 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of an isolation gown, with no mention of AI or ML technologies.
No.
This device is an isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
This device is an isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (Basic Gown, Belt, Cuff, Hook-and-loop Velcro, Seam Sealing Tape) made of materials like polypropylene and polyethylene, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical components and materials of a protective gown. There is no mention of reagents, assays, or any components used to test samples from the human body.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This gown does not perform any such examination.
The device is clearly described as a medical device intended for protection, specifically an isolation gown.
N/A
Intended Use / Indications for Use
The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.
Product codes
FYC
Device Description
The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile.
There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care personnel and patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test
- AATCC 42: 2017 Water Resistance: Impact Penetration Test
- ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- 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
- ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
Key results from performance testing:
- Flammability: Class 1
- Hydrostatic pressure: Gown sleeve: 188 cmH2O, Sleeve seam: 80 cmH2O, Body-sleeve seam: 65 cmH2O, Gown body: 199 cmH2O, Belt attachment: 74 cmH2O (Acceptance Criteria: >50 cm)
- Water impact: Gown sleeve: 0g, Sleeve seam: 0g, Body-sleeve seam: 0g, Gown body: 0g, Belt attachment: 0g (Acceptance Criteria: 20 N)
- Tearing strength: MD: Mean 31.6 N, CD: Mean 22.9 N (Acceptance Criteria: >20 N)
- Linting: Log10(lint count): Mean 2.5 (Acceptance Criteria: Log10(particle count) 50 N)
- Viral barrier (resistance to bacteriophage Phi-X174): No bacteriophage penetration (Acceptance Criteria: No bacteriophage penetration)
Results from biocompatibility testing:
- Cytotoxicity: The viability was >=70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic.
- Sensitization: Under the conditions of the study, the proposed device was non-sensitizing.
- Irritation: Under the conditions of the study, the proposed device was non-irritating.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 11, 2022
Hubei Xinxin Non-woven Co.,Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K214116
Trade/Device Name: AAMI4 Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: September 8, 2022 Received: September 13, 2022
Dear Diana Hong:
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.
1
542 of the Act); 21 CFR 1000-1050.
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-
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K214116
Device Name AAMI4 Isolation Gown
Indications for Use (Describe)
The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K214116
-
- Date of Preparation: 10/08/2022
-
- Sponsor Identification
Hubei Xinxin Non-woven Co., Ltd. Taizihu Industrial Park, Pengchang Town, Xiantao, Hubei,433018, China
Contact Person: Nicole Jin Position: QA Manager Tel: +86-728-2618155 Email: nicole jin(@xtxfsl.com
-
- Designated Submission Correspondent Ms.
Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent Ms.
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: AAMI4 Isolation Gown Common Name: Surgical Isolation Gown
Regulatory Information
Classification Name: Surgical Isolation Gown Classification: II Product Code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
Indications for Use:
The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown a single use, disposable medical device provided non-sterile.
Device Description:
The proposed device, AAMI4 Isolation Gown, is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile.
There is one model of AAMI4 Isolation Gown: 4015T. And the proposed AAMI4 Isolation Gown is available in one product size: U. The barrier protection level for AAMI4 Isolation Gown meets AAMI Level 4. The proposed device consists of five components: 1) Basic Gown, 2) Belt, 3) Cuff, 4) Hook-and-loop Velcro and 5) Seam Sealing Tape. The gown is made of polypropylene and polyethylene laminating. The gown is blue in color.
5. Identification of Predicate Device
510(k) Number: K190306 Product Name: AMD Ritmed AssureWear™ VersaGown
5
6. Summary of Technological characteristics
| Item | Proposed Device K214116 | Predicate Device K190306 | Remark |
|---|---|---|---|
| Product Code | FYC | FYC | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | The AAMI4 Isolation Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown a single use, disposable medical device provided non-sterile. | AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and X-large sizes. | Similar |
| Design | Tape, Neck closure, Belt tie, Elastic cuffs | Thumb loop, Elastic cuffs, Extended cuff (Thumb loop), Flexneck™, Tie (neck), Straight sleeve, Inclined sleeve, Blue belt tie, Reinforced seams | Similar |
| Use | Single use; disposable | Single use; disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device K214116 | Predicate Device K190306 | Remark |
| Weight per | |||
| square (g) | 43 g/m² | 39.97 ± 1.61 g/m² | |
| (1.17 oz/yd² ± 0.05) | Different | ||
| Size | Universal (U) | Large and X-large | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic | |||
| pressure | Gown sleeve: 188 cmH₂O | ||
| Sleeve seam: 80 cmH₂O | |||
| Body-sleeve seam: 65 cmH₂O | |||
| Gown body: 199 cmH₂O | |||
| Belt attachment: 74 cmH₂O | Chest: 109.34 ± 0.34 cmH₂O | ||
| Sleeve seams: 110.67 ± 3.84 cmH₂O | |||
| Belt attachments: 104 ± 5.19 cmH₂O | |||
| Body/sleeve/belt mean: 108 ± 3.1 cmH₂O | Different | ||
| Water impact | Gown sleeve: 0g | ||
| Sleeve seam: 0g | |||
| Body-sleeve seam: 0g | |||
| Gown body: 0g | |||
| Belt attachment: 0g | Chest: 0.3: 2.07; >0.5: 1.97 | ||
| Index for Particulate Matter (IPM): 1.50 | |||
| Inside: Total linting >0.3: 2.16; >0.5: 2.00 | |||
| Index for Particulate Matter (IPM): 1.35 | Different | ||
| Seam strength | Mean 70.9 N | / | Different |
| Barrier | |||
| protection level | Level 4 per AAMI PB 70 | Level 3 per AAMI PB 70 | Different |
| Viral barrier | |||
| (resistance to | |||
| bacteriophage | |||
| Phi-X174) | Pass | / | Different |
| Material | Polypropylene and polyethylene | ||
| laminating | PP SMS non-woven + PE | Same | |
| Biocompatibility | |||
| Cytotoxicity | Under the condition of the | Under the condition of the study, not | Same |
| study, not cytotoxic | cytotoxic | ||
| Irritation | Under the condition of the study, not an irritant. | Under the condition of the study, not an irritant. | Same |
| Sensitization | Under the condition of the study, not a sensitizer. | Under the condition of the study, not a sensitizer. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
6
Table 2 Safety and Effectiveness Comparison
7
Similar - Indications for Use
The indications for use of the proposed device and predicate device are not exactly the same, the main difference is that the proposed device is a level 4 isolation gown, while the predicate device is a level 3 isolation gown. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. And the performance testing for proposed device was also performed and the results demonstrated that the proposed AAMI4 Isolation Gown can meet the barrier protection level 4 requirement. Therefore, these differences will not affectiveness of the proposed device.
Similar - Design
The design of the proposed device and predicate device are not exactly the same. The proposed device does not have the Thumb loop and Flexneck™ patented design compared to the predicate device. However, this does not affect the intended use. In addition, the performance testing results demonstrated that the proposed AAMI4 Isolation Gown can meet the barrier protection level 4 required by PB70. Therefore, these differences will not affect the safety and effectiveness of the proposed device.
Different - Weight per square
The weight per square of the proposed device is different from the predicate device. The weight per of the proposed device is 43 g/m², and the predicate device is 39.97 g/m². However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrate that the proposed isolation gown can meet the barrier protection level 4 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Size
The size for the proposed device is different from the predicate device. The proposed device is available in one size universal (U), while the predicate device is available in sizes large and X-large. However, the difference in the size will not affect the device performance. This difference will not affect the safety and effectiveness of the proposed device.
Different - Hydrostatic pressure
The hydrostatic pressure for the proposed device is different from the predicate device. However, the hydrostatic pressure results demonstrate that the proposed device meets the barrier protection level 4
8
requirement, i.e., at least 50cmH2O, as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Water impact
The water impact for the proposed device is different from the predicate device. However, the water impact test was conducted on the proposed device and the results demonstrate that the proposed device meets the barrier protection level 4 requirement, i.e., no more than 1.0g, as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Breaking strength
The breaking strength for the proposed device is different from the predicate device. Breaking strength is one of the indicators to evaluate the ability of the isolation gown to withstand destructive force. The higher the breaking strength value, the stronger the ability to withstand destructive force. The MD and CD breaking strength of the proposed device are higher than the predicate device. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Tearing strength
The tearing strength for the proposed device is different from the predicate device. The CD tearing strength of the proposed device is similar to the predicate device, while the MD tearing strength of the proposed device is smaller than the predicate device. However, the CD and MD tearing strength of the proposed device meets ASTM F2407-20's requirement of greater than 10N. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Linting
The water linting for the proposed device is different from the predicate device. However, the linting test was conducted on the proposed device and the testing results demonstrate that the proposed device can meet the requirements of log10
-
AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
-
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
-
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
-
ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
-
ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
-
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test):
-
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:
- A ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
-
ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System:
| Test
Methodology | Purpose | Acceptance
Criteria | Result |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Flammability | The test was performed in
accordance with 16 CFR Part 1610
Standard for the Flammability of | Meets Class 1
requirements | Class 1 |
| | Clothing Textiles to evaluate the
flammability of the test sample. | | |
| Hydrostatic
pressure | The test was performed in
accordance with AATCC 127: 2017
Water Resistance: Hydrostatic
Pressure Test to determine the
hydrostatic pressure of the test
sample. | >50 cm | Gown sleeve: 188 cmH2O
Sleeve seam: 80 cmH2O
Body-sleeve seam: 65 cmH2O
Gown body: 199 cmH2O
Belt attachment: 74 cmH2O |
| Water impact | The test was performed in
accordance with AATCC 127: 2017
Water Resistance: Hydrostatic
Pressure Test to determine the
hydrostatic pressure of the test
sample. | ≤1.0 g | Gown sleeve: 0g
Sleeve seam: 0g
Body-sleeve seam: 0g
Gown body: 0g
Belt attachment: 0g |
| Breaking
strength | The test was performed in
accordance with ASTM D
5034:2009(2017) Standard Test
Method for Breaking Strength and
Elongation of Textile Fabrics (Grab
Test) to evaluate the breaking
strength of the test sample. | >20 N | MD: Mean 87.3 N
CD: Mean 66.7 N |
| Tearing
strength | The test was performed in
accordance with ASTM
D5587:2015(2019) Standard Test
Method for Tearing Strength of
Fabrics by Trapezoid Procedure to
evaluate the tearing strength of the
test sample. | >20 N | MD: Mean 31.6 N
CD: Mean 22.9 N |
| Linting | The test was performed in
accordance with ISO 9073-10:2003
Textiles-Test Methods for
Nonwovens-Pat 10: Lint and Other
Particles Generation in the Dry
State to evaluate the linting of the
test sample. | Log10(particle
count) 50 N | Mean 70.9 N |
| | evaluate the seam strength of the test sample. | | |
| Viral barrier
(resistance to
bacteriophage
Phi-X174) | The test was performed in accordance with ASTM F1671/F1671M-13 Standard Test
Method for Resistance of Materials
Used in Protective Clothing to
Penetration by Blood-Borne
Pathogens Using Phi-X174
Bacteriophage Penetration as a Test
System evaluate the resistance to
bacteriophage penetration | No
bacteriophage
penetration | No bacteriophage penetration |
Table 3 Summary of Performance Testing
10
11
| Table 4 Summary of Biocompatibility Testing | ||
|---|---|---|
| Test
| Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | performed | ||
| The test | |||
| was | |||
| in | |||
| accordance with ISO 10993-5 | |||
| Third | |||
| edition | |||
| 2009-06-01 | |||
| Biological evaluation of medical | |||
| devices - Part 5: Tests for in | |||
| vitro cytotoxicity to evaluate the | |||
| cytotoxicity of the test sample. | The viability should be | ||
| ≥ 70% of the blank. | |||
| And the 50% extract of | |||
| the test sample should | |||
| have at least the same or | |||
| a higher viability than | |||
| the 100% extract. | The viability was ≥70% | ||
| of the blank. And the | |||
| 50% extract of the test | |||
| sample had a higher | |||
| viability than the 100% | |||
| Under | |||
| extract. | |||
| the | |||
| conditions of the study, | |||
| the proposed device | |||
| was non-cytotoxic. | |||
| Sensitization | The test was performed | ||
| in | |||
| accordance with ISO 10993-10 | |||
| Third | |||
| Edition | |||
| 2010-08-01 | |||
| Biological evaluation of medical | |||
| devices - Part 10: Tests for | |||
| irritation and skin sensitization | |||
| to evaluate the sensitization of | |||
| the test sample. | Non-sensitizing | Under the conditions of | |
| the study, the proposed | |||
| device | |||
| was | |||
| non-sensitizing. | |||
| Irritation | The test was performed | ||
| in | |||
| accordance with ISO 10993-10 | |||
| Third | |||
| Edition | |||
| 2010-08-01 | |||
| Biological evaluation of medical | |||
| devices - Part 10: Tests for | |||
| irritation and skin sensitization | |||
| to evaluate the irritation of the | Non-irritating | Under the conditions of | |
| the study, the proposed | |||
| device | |||
| was | |||
| non-irritating. |
12
| test sample. | |||
|---|---|---|---|
| -- | -------------- | -- | -- |
8. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device K190306.
- Conclusion