(88 days)
Not Found
No
The device is a surgical gown, and the description focuses on its physical properties, barrier performance, and sterilization methods. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to treat or cure a disease or condition.
No.
The device is a surgical gown, intended to protect from transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device description clearly indicates it is a physical surgical gown made of SMMS and BVB materials, with varying weights and sizes. It is a tangible, disposable 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 clearly states the surgical gown is for protecting 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 function.
- Device Description: The description focuses on the physical properties of the gown (materials, weight, sizes, barrier levels) and its function as a protective barrier. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Performance Studies: The performance studies listed evaluate the physical and barrier properties of the gown (flammability, strength, barrier to fluids and viruses, biocompatibility, sterilization residuals, packaging integrity). These are not studies related to diagnosing a disease or condition.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not perform any of these functions.
Therefore, the surgical gown described is a medical device intended for protection and barrier function, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgical gown is 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/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 to ISO 11135-1.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The proposed devices 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. The proposed devices are single use, disposable medical devices and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.
The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.
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 during surgical procedure
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 devices. The test results demonstrated 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);
- ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
- ASTM F88/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;
- ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
- 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
- ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- 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
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
Key Results:
- Flammability: Class 1
- Hydrostatic pressure: All proposed devices met the acceptance criteria for their respective AAMI levels. For example, 35g Standard SMMS Surgical Gown (Non-sterile) had an average of 40.57cm (Level 2 requires >20 cm H2O). BVB Surgical Gown had an average of 161.71 cm (Non-sterile) and 162.11 cm (Sterile) (Level 4 requires >50 cm H2O).
- Water impact: All proposed devices met the acceptance criteria (≤1.0 g). For example, 35g Standard SMMS Surgical Gown (Non-sterile) had an average of 0.041g.
- Breaking strength: All proposed devices met the acceptance criteria (≥30N).
- Tearing strength: All proposed devices met the acceptance criteria (≥10N).
- Linting: All proposed devices met the acceptance criteria (Log10(particle count) = 70% of the blank. Non-cytotoxic.
- Sensitization: Non-sensitizing.
- Irritation: Non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. See Summary of Performance Studies for other metrics.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
September 19, 2022
Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K221819
Trade/Device Name: 35g Standard Surgical Gown; 35g Reinforced SMMS Surgical Gown; 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: May 18, 2022 Received: June 23, 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K221819
Device Name
35g Standard SMMS Surgical Gown, 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown, 50g Reinforced SMMS Surgical Gown, BVB Surgical Gown
Indications for Use (Describe)
Surgical gown is 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/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 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.
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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: K221819
-
- Date of Preparation: 09/19/2022
-
- Sponsor Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109
Establishment Registration Number: 9616433
Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnermedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
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: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown: 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown 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
Indications for Use:
Surgical gown is 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 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.
Device Description:
The proposed devices 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. The proposed devices are single use, disposable medical devices
5
and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.
The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.
| Proposed device | Size | Gram weight | Color | Style | AAMI Level | Sterilization |
|---|---|---|---|---|---|---|
| 35g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 35 g/m² | Blue | Standard | 2 | Sterile/Non-sterile |
| 35g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 35 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile |
| 43g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 43 g/m² | Blue | Standard | 3 | Sterile/Non-sterile |
| 43g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 43 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile |
| 50g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 50 g/m² | Blue | Standard | 3 | Sterile/Non-sterile |
| 50g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 50 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile |
| BVB Surgical Gown | M, L, LL, XL, XLL, XXL | 64 g/m² | Blue | Standard | 4 | Sterile/Non-sterile |
Table 1. Specification
6
ડ. Identification of Predicate Devices
Predicate Device 1 510K Number: K211422 Trade Name: Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown Level 3 Reinforced Surgical Gown
Predicate Device 2 510K Number: K192290 Trade Name: SMS Standard Surgical Gown SMS Surgical Gown with Reinforcement BVB Surgical Gown (used as predicate device 2) BVB Splicing Surgical Gown
Summary of Technological characteristics 6.
| Item | Proposed Device
K221819 | Predicate Device 1
K211422 | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product
Name | 35g Standard SMMS Surgical Gown,
35g Reinforced SMMS Surgical Gown,
43g Standard SMMS Surgical Gown,
43g Reinforced SMMS Surgical Gown,
50g Standard SMMS Surgical Gown,
50g Reinforced SMMS Surgical Gown | Level 2 Standard Surgical Gown,
Level 3 Standard Surgical Gown, /
Level 3 Reinforced Surgical Gown | |
| Product Code | FYA | FYA | Same |
| Regulation
No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for
Use | Surgical gown is 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. | Surgical gown is 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. | Same |
| | Per ANSI/AAMI PB70:2012 Liquid | Per ANSI/AAMI PB70:2012 Liquid | |
Table 2. General Comparison for SMMS Surgical Gown
7
| barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification. | barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification. | ||
|---|---|---|---|
| Style | Standard/Reinforced | Non-reinforced/Reinforced | Same |
| 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 3. Safety and Effectiveness Comparison for SMMS Surgical Gown
| Item | Proposed Device
K221819 | Predicate Device 1
K211422 | Remark |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Name | 35g Standard SMMS Surgical Gown,
35g Reinforced SMMS Surgical Gown,
43g Standard SMMS Surgical Gown,
43g Reinforced SMMS Surgical Gown,
50g Standard SMMS Surgical Gown,
50g Reinforced SMMS Surgical Gown | Level 2 Standard Surgical Gown,
Level 3 Standard Surgical Gown, /
Level 3 Reinforced Surgical Gown | |
| Weight
per
square (g) | 35g Standard SMMS Surgical Gown
and 35g Reinforced SMMS Surgical
Gown: 35g/m²
43g Standard SMMS Surgical Gown
and 43g Reinforced SMMS Surgical
Gown: 43g/m²
50g Standard SMMS Surgical Gown
and 50g Reinforced SMMS Surgical
Gown: 50g/m² | Level 2 Standard Surgical Gown:
35g/m²
Level 3 Standard Surgical Gown:
43g/m²
Level 3 Reinforced Surgical Gown:
35g/m² and 28g/m² | Different |
| Size | M, L, LL, XL, XLL, XXL | XS, S, M, L, XL, XXL, XXXL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic
pressure | 35g Standard SMMS Surgical Gown
(Non-sterile): Average 40.57cm; | Level 2 Standard Surgical
Gown: >20 cm; | Different |
| | 35g Standard SMMS Surgical Gown | Level 3 Standard Surgical | |
| | (Sterile): Average 40.21cm; | Gown: >50 cm; | |
| | 35g Reinforced SMMS Surgical Gown | Level 3 Reinforced Surgical | |
| | (Non-sterile): Average 83.53cm; | Gown: >50 cm | |
| | 35g Reinforced SMMS Surgical Gown
(Sterile): Average 83.57cm; | | |
| | 43g Standard SMMS Surgical Gown
(Non-sterile): Average 60.50 cm; | | |
| | 43g Standard SMMS Surgical Gown
(Sterile): Average 60.48 cm; | | |
| | 43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 99.59 cm; | | |
| | 43g Reinforced SMMS Surgical Gown
(Sterile): Average 98.90 cm; | | |
| | 50g Standard SMMS Surgical Gown
(Non-sterile): Average 83.19 cm; | | |
| | 50g Standard SMMS Surgical Gown
(Sterile): Average 83.02 cm; | | |
| | 50g Reinforced SMMS Surgical Gown
(Non-sterile): Average 108.37 cm; | | |
| | 50g Reinforced SMMS Surgical Gown
(Sterile): Average 108.37 cm; | | |
| Water impact | 35g Standard SMMS Surgical Gown
(Non-sterile): Average 0.041g; | ≤1.0 g | Different |
| | 35g Standard SMMS Surgical Gown
(Sterile): Average 0.03g; | | |
| | 35g Reinforced SMMS Surgical Gown
(Non-sterile): Average 0.03g; | | |
| | 35g Reinforced SMMS Surgical Gown
(Sterile): Average 0.029g; | | |
| | 43g Standard SMMS Surgical Gown
(Non-sterile): Average 0.036g; | | |
| | 43g Standard SMMS Surgical Gown
(Sterile): Average 0.033g; | | |
| | 43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 0.032g; | | |
| | 43g Reinforced SMMS Surgical Gown
(Sterile): Average 0.032g; | | |
| | 50g Standard SMMS Surgical Gown
(Non-sterile): Average 0.031g; | | |
| Breaking
strength | 50g Standard SMMS Surgical Gown (Sterile): Average 0.034g;
50g Reinforced SMMS Surgical Gown (Non-sterile): Average 0.033g
50g Reinforced SMMS Surgical Gown (Sterile): Average 0.031g
35g Standard SMMS Surgical Gown (Non-sterile):
Latitude: 108.37N;
Longitude: 161.87N;
35g Standard SMMS Surgical Gown (Sterile):
Latitude: 108.37N
Longitude: 161.87N;
35g Reinforced SMMS Surgical Gown (Non-sterile):
Latitude: 108.72N
Longitude: 161.19N;
35g Reinforced SMMS Surgical Gown (Sterile):
Latitude: 108.53N
Longitude: 161.31N; | | |
| | 43g Standard SMMS Surgical Gown (Non-sterile):
Latitude: 113.34N
Longitude: 182.30N;
43g Standard SMMS Surgical Gown (Sterile):
Latitude: 113.01N
Longitude: 181.05 N;
43g Reinforced SMMS Surgical Gown (Non-sterile):
Latitude: 113.72N
Longitude: 181.14 N;
43g Reinforced SMMS Surgical Gown (Sterile):
Latitude: 112.60N
Longitude: 181.26N;
50g Standard SMMS Surgical Gown (Non-sterile): | >20N | Different |
| Tearing
strength | Latitude: 137.58N
Longitude: 190.87 N;
50g Standard SMMS Surgical Gown
(Sterile):
Latitude: 137.77N
Longitude: 188.30 N;
50g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 138.02N
Longitude: 191.32N;
50g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 138.39N
Longitude: 190.07 N;
35g Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 32.49 N
Longitude: 39.67 N;
35g Standard SMMS Surgical Gown
(Sterile):
Latitude: 32.31N
Longitude: 39.81N;
35g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 32.44N
Longitude: 39.67N;
35g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 32.55N
Longitude: 39.92N;
43g Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 33.99N
Longitude: 41.40N;
43g Standard SMMS Surgical Gown
(Sterile):
Latitude: 33.92N
Longitude: 41.75N;
43g Reinforced SMMS Surgical Gown
(Non-sterile) | >20N | Different |
| | Latitude: 34.09N
Longitude: 41.51;
43g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 34.01N
Longitude: 41.18N;50g
Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 44.02N
Longitude: 54.18N;
50g Standard SMMS Surgical Gown
(Sterile):
Latitude: 44.36N
Longitude: 54.07N;
50g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 43.93N
Longitude: 53.96N;
50g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 44.30N
Longitude: 54.25N;
35g Standard SMMS Surgical Gown
(Non-sterile): Average 41.90N
35g Standard SMMS Surgical Gown
(Sterile): Average 42.21N
35g Reinforced SMMS Surgical Gown
(Non-sterile): Average 41.75N
35g Reinforced SMMS Surgical Gown
(Sterile): Average 41.74N
43g Standard SMMS Surgical Gown
(Non-sterile): Average 44.51N
43g Standard SMMS Surgical Gown
(Sterile): Average 44.56N
43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 44.55N
43g Reinforced SMMS Surgical Gown
(Sterile): Average 44.34N
50g Standard SMMS Surgical Gown
(Non-sterile): Average 50.52N | >30N | Different |
| Seam strength | | | |
| 50g Standard SMMS Surgical Gown
(Sterile): Average 50.45N
50g Reinforced SMMS Surgical Gown
(Non-sterile): Average 50.45N
50g Reinforced SMMS Surgical Gown
(Sterile): Average 50.57N | | | |
| Linting | Log10(particle count) 30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier
protection
level | Level 2 and 3 per AAMI PB 70 | Level 2 and 3 per AAMI PB 70 | Same |
| Material | Standard SMMS Surgical Gown:
Non-woven SMMS Fabric, Polyester,
Mixing polyester with nylon
Reinforced SMMS Surgical Gown:
Non-woven SMMS Fabric, Polyester,
Mixing polyester with nylon, PP and
PE fabric | Level 2 Standard Surgical Gown
and Level 3 Standard Surgical
Gown: SMS nonwoven, Polyester
and Polyamide;
Level 3 Reinforced Surgical Gown:
SMS nonwoven, Polyester,
Polyamide and Hydrophilic
nonwoven | Different |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, the | Under the conditions of the study, | |
| Irritation
Sensitization | device is non-toxic, non-irritating, and
non-sensitizing. | the device is non-toxic,
non-irritating, and non-sensitizing. | Same |
| Sterilization | Sterile/Non-sterile
Sterile Method: Ethylene Oxide (EO);
Sterilization Assurance Level (SAL):
10-6 | Sterile
Method: Ethylene Oxide (EO);
Sterilization Assurance Level
(SAL): 10-6 | Different |
| Ethylene
Oxide
Residuals | EO:50 cm | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking
strength | BVB Surgical Gown (Non-sterile):
Latitude: 148.44N
Longitude: 236.60N | Latitude: 92.3N
Longitude: 177.11N | Different |
| | BVB Surgical Gown (Sterile):
Latitude:148.93N
Longitude: 237.72 N | | |
| Tearing
strength | BVB Surgical Gown (Non-sterile):
Latitude: 49.76N
Longitude: 53.97N | Latitude: 35.30N
longitude: 56.46N | Different |
| | BVB Surgical Gown (Sterile):
Latitude: 49.23N
Longitude: 53.98 N | | |
| Seam strength | BVB Surgical Gown (Non-sterile):
70.27N
BVB Surgical Gown (Sterile): 70.35N | >70N | Different |
| Linting | Log10(particle count) 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- A AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
- A 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;
- A ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
-
ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
18
- ASTM F88/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;
-
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
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
-
ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
-
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
- ▲ ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
| Test
| Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Flammability | The test was performed in | ||
| accordance with 16 CFR | |||
| Part 1610 Standard for the | |||
| Flammability of Clothing | |||
| Textiles to evaluate the | |||
| flammability of the test | |||
| sample. | Meets Class 1 | ||
| requirements | Class 1 | ||
| Hydrostatic | |||
| pressure | The test was performed in | ||
| accordance with AATCC | |||
| 127: 2018 Water | |||
| Resistance: Hydrostatic | |||
| Pressure Test to determine | |||
| the hydrostatic pressure of | |||
| the test sample. | Level 2 Surgical | ||
| Gown: >20 cm H2O; | |||
| Level 3 Surgical | |||
| Gown: >50 cm H2O; | |||
| Level 4 Surgical | |||
| Gown: >50 cm H2O; | 35g Standard SMMS Surgical | ||
| Gown (Non-sterile): Average | |||
| 40.57cm; | |||
| 35g Standard SMMS Surgical | |||
| Gown (Sterile): Average | |||
| 40.21cm; | |||
| 35g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 83.53cm; | |||
| 35g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average | |||
| 83.57cm; | |||
| 43g Standard SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 60.50 cm; | |||
| 43g Standard SMMS Surgical | |||
| Gown (Sterile): Average 60.48 | |||
| cm; | |||
| 43g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 99.59 cm; | |||
| 43g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average 98.90 | |||
| cm; | |||
| 50g Standard SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 83.19 cm; | |||
| 50g Standard SMMS Surgical | |||
| Gown (Sterile): Average 83.02 | |||
| cm; | |||
| 50g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 108.37 cm; | |||
| 50g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average 108.37 | |||
| cm; | |||
| BVB Surgical Gown | |||
| (Non-sterile): Average 161.71 | |||
| cm; | |||
| BVB Surgical Gown (Sterile): | |||
| Average | |||
| 162.11 cm | |||
| 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; | 35g Standard SMMS Surgical | |
| Gown (Non-sterile): Average | |||
| 0.041g; | |||
| 35g Standard SMMS Surgical | |||
| Gown (Sterile): Average 0.03g; | |||
| 35g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 0.03g; | |||
| 35g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average 0.029g; | |||
| 43g Standard SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 0.036g; | |||
| 43g Standard SMMS Surgical | |||
| Gown (Sterile): Average 0.033g; | |||
| 43g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 0.032g; | |||
| 43g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average 0.032g; | |||
| 50g Standard SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 0.031g; | |||
| 50g Standard SMMS Surgical | |||
| Gown (Sterile): Average 0.034g; | |||
| 50g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): Average | |||
| 0.033g | |||
| 50g Reinforced SMMS Surgical | |||
| Gown (Sterile): Average 0.031g; | |||
| BVB Surgical Gown | |||
| (Non-sterile): Average 0.078g; | |||
| BVB Surgical Gown (Sterile): | |||
| Average | |||
| 0.079g | |||
| 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. | ≥30N | 35g Standard SMMS Surgical | |
| Gown (Non-sterile): | |||
| Latitude: 108.37N; | |||
| Longitude: 161.87N; | |||
| 35g Standard SMMS Surgical | |||
| Gown (Sterile): | |||
| Latitude: 108.37N | |||
| Longitude: 161.87N; | |||
| 35g Reinforced SMMS Surgical | |||
| Gown (Non-sterile): | |||
| Latitude: 108.72N | |||
| Longitude: 161.19N; |
Table 6. Summary of Performance Testing
19
20
21
| | 35g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 108.53N
Longitude: 161.31N; |
|--|--------------------------------------------------------------------------------------------------|
| | 43g Standard SMMS Surgical
Gown (Non-sterile):
Latitude: 113.34N
Longitude: 182.30N; |
| | 43g Standard SMMS Surgical
Gown (Sterile):
Latitude: 113.01N
Longitude: 181.05 N; |
| | 43g Reinforced SMMS Surgical
Gown (Non-sterile):
Latitude: 113.72N
Longitude: 181.14 N; |
| | 43g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 112.60N
Longitude: 181.26N; |
| | 50g Standard SMMS Surgical
Gown (Non-sterile):
Latitude: 137.58N
Longitude: 190.87 N; |
| | 50g Standard SMMS Surgical
Gown (Sterile):
Latitude: 137.77N
Longitude: 188.30 N; |
| | 50g Reinforced SMMS Surgical
Gown (Non-sterile):
Latitude: 138.02N
Longitude: 191.32N; |
| | 50g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 138.39N
Longitude: 190.07 N; |
| | BVB Surgical Gown
(Non-sterile):
Latitude: 148.44N
Longitude: 236.60N |
22
| 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. | ≥10N | BVB Surgical Gown (Sterile):
Latitude:148.93N
Longitude: 237.72 N
35g Standard SMMS Surgical
Gown (Non-sterile):
Latitude: 32.49 N
Longitude: 39.67 N;
35g Standard SMMS Surgical
Gown (Sterile):
Latitude: 32.31N
Longitude: 39.81N;
35g Reinforced SMMS Surgical
Gown (Non-sterile):
Latitude: 32.44N
Longitude: 39.67N;
35g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 32.55N
Longitude: 39.92N;
43g Standard SMMS Surgical
Gown (Non-sterile):
Latitude: 33.99N
Longitude: 41.40N;
43g Standard SMMS Surgical
Gown (Sterile):
Latitude: 33.92N
Longitude: 41.75N;
43g Reinforced SMMS Surgical
Gown (Non-sterile)
Latitude: 34.09N
Longitude: 41.51;
43g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 34.01N
Longitude: 41.18N;50g
Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 44.02N
Longitude: 54.18N;
50g
Standard SMMS
Surgical |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | | | Gown (Sterile):
Latitude: 44.36N
Longitude: 54.07N;
50g Reinforced SMMS Surgical
Gown (Non-sterile):
Latitude: 43.93N
Longitude: 53.96N;
50g Reinforced SMMS Surgical
Gown (Sterile):
Latitude: 44.30N
Longitude: 54.25N;
BVB Surgical Gown
(Non-sterile):
Latitude: 49.76N
Longitude: 53.97N
BVB Surgical Gown (Sterile):
Latitude: 49.23N
Longitude: 53.98 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)