(115 days)
Not Found
No
The device is a surgical gown, and the description focuses on material properties, barrier performance, and sterilization. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device, a surgical gown, is intended to protect operating room personnel and patients from the transfer of microorganisms and fluids, not to provide therapy.
No
The device described is a surgical gown, intended to protect from transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device described is a physical surgical gown made of SMS nonwoven material. The summary details its physical properties, barrier performance, and sterilization methods, with no mention of software components.
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 operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and construction of the gown for protection and barrier performance.
- Performance Studies: The performance studies evaluate the physical properties of the gown (hydrostatic pressure, water resistance, tearing strength, etc.) and biocompatibility, which are relevant to its barrier and protective function, not diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical gown does not fit that definition.
N/A
Intended Use / Indications for Use
The proposed surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
Product codes
FYA
Device Description
The proposed surgical gowns 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. The proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.
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
Operating room personnel / Operating Room
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 specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities:
Performance Testing:
- Hydrostatic Pressure (AATCC 127-2018):
- Purpose: To measure the resistance of a fabric to the penetration of water under hydrostatic pressure.
- Sample size: 3 non-consecutive lots tested, using a sample size of 32/lot.
- Key Result: Passed. All parts of test specimen met the level 3 requirements.
- Water Resistance (AATCC 42-2017):
- Purpose: To verify the impact penetration of the device.
- Sample size: 3 non-consecutive lots tested, using a sample size of 32/lot.
- Key Result: Passed. All parts of test specimen met the level 3 requirements.
- Tearing Strength (ASTM D5587-15 (2019)):
- Purpose: To determine the tearing strength of the device.
- Sample size: 10 pcs
- Key Result: Passed. MD Mean: 34.39N, CD Mean: 18.06N.
- Breaking Strength (ASTM D5034-09 (2017)):
- Purpose: To determine the breaking strength and elongation of the device.
- Sample size: 10 pcs
- Key Result: Passed. MD Mean: 138.64N, CD Mean: 75.10N.
- Seam Strength (ASTM D1683/D1683M-17(2018)):
- Purpose: To measure the sewn seam strength in surgical gown by applying a force perpendicular to the sewn seams.
- Sample size: 10 pcs
- Key Result: Passed. Mean 57.56 N.
- Evaporative Resistance (ASTM F1868-17):
- Purpose: To measure the evaporative resistance under steady-state conditions of fabrics of the device.
- Sample size: 3pcs
- Key Result: Passed. 0.00315 kPa ⋅ m²/W.
- Lint and other particles generation in the dry state (ISO 9073-10-2003):
- Purpose: To measure the linting of non-woven in the dry state.
- Sample size: 10pcs
- Key Result: Passed. Log₁₀ Mean: 2.7.
- Flammability (16 CFR 1610):
- Purpose: To determine the flammability of textiles for the surgical gowns.
- Sample size: 5 pcs
- Key Result: Passed. All samples are Class I.
Biocompatibility Testing:
- Cytotoxicity (ISO 10993-5:2009):
- Purpose: Assess the potential risk of cytotoxicity of surgical gown material.
- Key Result: Passed. Under the condition of this study, the device has no potential toxicity.
- Irritation (ISO 10993-10:2010):
- Purpose: Assess the potential risk of irritation of surgical gown material.
- Key Result: Passed. Under the condition of this study, the device is negligibly irritating.
- Sensitization (ISO 10993-10:2010):
- Purpose: Assess the potential risk of sensitization of surgical gown material.
- Key Result: Passed. Under the conditions of the study, the device is non-sensitizing.
- Ethylene Oxide Residuals (ISO 10993-7:2008):
- Purpose: Verify low levels of sterilant residuals.
- Key Result: Passed. The EO/ECH residuals shown in test report are far below the criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Hydrostatic Pressure: ≥50cm H2O
- Water Resistance: ≤1.0g
- Tearing Strength: ≥10N (MD Mean: 34.39N, CD Mean: 18.06N)
- Breaking Strength: ≥30N (MD Mean: 138.64N, CD Mean: 75.10N)
- Seam Strength: ≥30N (Mean 57.56 N)
- Evaporative Resistance: ≤1.0kPa·m²/W (0.00315 kPa • m²/W)
- Linting: Coefficient of linting Log₁₀≤4.0 (Log₁₀ Mean: 2.7)
- Flammability: Class I
- Cytotoxicity: Non-cytotoxic
- Irritation: Negligibly irritating
- Sensitization: Non-sensitizing
- Ethylene Oxide Residuals: EO residual
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
September 29, 2022
Allmed Medical (Hubei) Protective Products Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K221637
Trade/Device Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 2, 2022 Received: September 2, 2022
Dear Ivy Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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. 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
2
Indications for Use
510(k) Number (if known) K221637
Device Name
Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Indications for Use (Describe)
The proposed surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China
510(K) Summary
K221637
(As requirement by 21 CFR 807.92)
Date prepared: 29th, September, 2022
A. Applicant:
Name: Allmed Medical (Hubei) Protective Products Co., Ltd Address: No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Contact Person: Vince Tian Title: General Manager of Quality Tel: 86 717 4215906 Fax: 86 717 4215989 Email: vince@allmed.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile) Common Name: Surgical Gown Model: S, M, L, XL, XXL and XXXL
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
C. Predicate device:
K202706 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. Trade Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile)
4
Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China
Common Name: Surgical Gown
Regulatory Information Classification Name: Gown, Surgical Classification: II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
D. Indications for use of the device:
The surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms,body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EiO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
E. Device Description:
The proposed surgical gowns 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. The proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.
F. Comparison Tables of Proposed and Predicate Devices
| Item | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K221637 | K202706 | - |
| Manufacturer | Allmed Medical (Hubei) Protective | ||
| Products Co., Ltd | B.J.ZH.F.PANTHER MEDICAL | ||
| EQUIPMENT CO., LTD. | - | ||
| Product Name | Surgical Gown (Sterile); Surgical Gown | ||
| (Non-sterile) | Surgical Gown (Sterile); Surgical | ||
| Gown (Non-sterile) | Same | ||
| Level | Level 3 | Level 3 | Same |
Table 1 General Comparison of Proposed and Predicate Devices
5
Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China
| Product Code | FYA | FYA | Same |
|---|---|---|---|
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for use | The surgical gowns are intended to be | ||
| worn by operating room personnel | |||
| during surgical procedure to protect both | |||
| the surgical patient and the operating | |||
| room personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. Per ANSI/AAMI | |||
| PB70:2012 Liquid barrier performance | |||
| and classification of protective apparel | |||
| and drapes intended for use in health | |||
| care facilities, the surgical gowns met the | |||
| requirements for Level 3 classification. |
Non-sterile gowns are to be sold to
re-packager/re-labeler establishments for
ethylene oxide (EtO) sterilization
according to ISO 11135-1 prior to
marketing to the end users and sterile
surgical gowns are to be sold directly to
the end users after EtO sterilization
validation to ISO 11135-1. | Surgical gowns are intended to be
worn by operating room personnel
during surgical procedure to protect
both the surgical patient and the
operating room personnel from
transfer of microorganisms, body
fluids, and particulate material. Per
ANSI/AAMI PB70:2012 Liquid
barrier performance and classification
of protective apparel and drapes
intended for use in health care
facilities, the surgical gowns met the
requirements for Level 3
classification. | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
Table 2 Performance Comparison of Proposed and Predicate Devices
| Item | Proposed Device | Predicate Device K202706 | Result |
|---|---|---|---|
| Weight per square (g) | $41\pm3g/m^2$ | $55g/m^2$ | Similar |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | $\ge50$ cm | $\ge50$ cm | Same |
| Water impact | $\le1.0g$ | $\le1.0g$ | Same |
| Breaking strength | MD Mean 138.64N | ||
| CD Mean 75.10N | >20N | Similar | |
| Tearing strength | MD Mean 34.39N | ||
| CD Mean 18.06N | >20N | Similar | |
| Seam strength | Mean 57.56 N | Not available on Predicate Device's | |
| 510K Summary | Similar |
6
Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China
| Evaporative
Resistance | $0.00315kPa \cdot m^2/W$ | Not available on Predicate Device's
510K Summary | Similar |
|-----------------------------|-------------------------------------------------|-----------------------------------------------------|---------|
| Linting | $Log_{10}$ Mean 2.7 | $Log_{10}$ AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities
-
AATCC 127-2018, Water Resistance: Hydrostatic Pressure Test
-
AATCC 42-2017, Water Penetration Resistance: Impact Penetration Test
- A ASTM D5034-09 (2017), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
-
ASTM D5587-15 (2019), Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
-
ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Seams of Woven Fabrics
-
ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
ISO 9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
-
16 CFR 1610, Standard for the Flammability of Clothing Textiles
-
ASTMF88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
-
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
ASTM F1886/F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
| Testing Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Performance Testing | |||
| Hydrostatic Pressure | |||
| AATCC 127-2018 | To measure the resistance of | ||
| a fabric to the penetration of | |||
| water under hydrostatic | |||
| pressure | ≥50cm H2O | Passed | |
| 3 non-consecutive lots | |||
| tested, using a sample | |||
| size of 32/lot. | |||
| All parts of test | |||
| specimen met the level | |||
| 3 requirements. | |||
| Water Resistance | |||
| AATCC 42-2017 | To verify the impact | ||
| penetration of the device. | ≤1.0g | Passed | |
| 3 non-consecutive lots | |||
| tested, using a sample | |||
| size of 32/lot. | |||
| All parts of test | |||
| specimen met the level | |||
| 3 requirements. | |||
| Tearing Strength | |||
| ASTM D5587-15 (2019) | To determine the tearing | ||
| strength of the device. | ≥10N | Passed | |
| Sample size of 10 pcs | |||
| MD Mean: 34.39N | |||
| CD Mean: 18.06N | |||
| Breaking Strength | |||
| ASTM D5034-09 (2017) | To determine the breaking | ||
| strength and elongation of | |||
| the device. | ≥30N | Passed | |
| Sample size of 10 pcs | |||
| MD Mean: 138.64N | |||
| CD Mean: 75.10N | |||
| Seam Strength | |||
| ASTM | |||
| D1683/D1683M-17(2018) | To measure the sewn seam | ||
| strength in surgical gown by | |||
| applying a force | |||
| perpendicular to the sewn | |||
| seams | ≥30N | Passed | |
| Sample size of 10 pcs | |||
| Mean 57.56 N | |||
| Evaporative Resistance | |||
| ASTM F1868-17 | To measure the evaporative | ||
| resistance under steady-state | |||
| conditions of fabrics of the | |||
| device. | ≤1.0kPa·m²/W | Passed | |
| Sample size of 3pcs | |||
| 0.00315 kPa • m²/W | |||
| Lint and other particles | |||
| generation in the dry state | |||
| ISO 9073-10-2003 | To measure the linting of | ||
| non-woven in the dry state. | Coefficient of linting | ||
| Log₁₀≤4.0 | Passed | ||
| Sample size of 10pcs | |||
| Log₁₀ Mean: 2.7 | |||
| Flammability | |||
| 16 CFR 1610 | To determine the | ||
| flammability of textiles for | |||
| the surgical gowns. | Class I | Passed | |
| Sample size of 5 pcs | |||
| All samples are Class I | |||
| Biocompatibility Testing | |||
| Cytotoxicity | Assess the potential risk of | ||
| cytotoxicity of surgical | |||
| gown material | Non-cytotoxic | Passed | |
| Under the condition of | |||
| this study, the device | |||
| has no potential | |||
| toxicity. | |||
| Irritation | Assess the potential risk of | ||
| irritation of surgical gown | |||
| material | Negligibly irritating | Passed | |
| Under the condition of | |||
| this study, the device is | |||
| negligibly irritating. | |||
| Sensitization | Assess the potential risk of | ||
| sensitization of surgical | |||
| gown material | Non-sensitizing | Passed | |
| Under the conditions | |||
| of the study, the device | |||
| is non-sensitizing | |||
| Ethylene Oxide Residuals | Verify low levels of sterilant | ||
| residuals | EO residual |