(95 days)
No
The device description and performance studies focus on the physical properties and barrier performance of surgical gowns, with no mention of AI or ML.
No
The device is a surgical gown designed to protect against the transfer of microorganisms and fluids, not to treat or diagnose a medical condition.
No
This device is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to diagnose a condition.
No
The device described is a physical surgical gown, not a software application. The summary details physical properties and performance testing related to barrier protection and material strength.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are 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 one.
- Device Description: The description reinforces the barrier function and mentions the physical characteristics and classification levels (Level 3 and 4) based on liquid barrier performance.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. There are no reagents, calibrators, controls, or analytical procedures described, which are typical components of IVDs.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on physical properties like barrier performance (hydrostatic pressure, water impact), strength (breaking, tearing), linting, air permeability, and biocompatibility (cytotoxicity, sensitization, irritation). These are relevant to the protective function of a surgical gown, not a diagnostic function.
In summary, the device is a protective barrier intended for use during surgery, not a tool for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements for Level 4 classification.
Product codes
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.
There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
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. 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: 2017 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 F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- 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
- ASTM F1671/F1671M-13 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens
Flammability: Pass
Hydrostatic Pressure: Level 3 Standard Surgical Gown: Average 67cm; Level 4 Standard Surgical Gown: Average 196cm; Level 4 Reinforced Surgical Gown: Average 162cm
Water impact: Level 3 Standard Surgical Gown: Average 0.011g; Level 4 Standard Surgical Gown: Average 0.014g; Level 4 Reinforced Surgical Gown: Average 0.017g
Breaking strength (Level 3 Standard Surgical Gown): Latitude: average 96N; Longitude: average 116N
Tearing strength (Level 4 Standard Surgical Gown): Latitude: average 111N; Longitude: average 184N; (Level 4 Reinforced Surgical Gown): Latitude: average 109N; Longitude: average 122N
Linting: Level 3 Standard Surgical Gown: Average 3.1; Level 4 Standard Surgical Gown: Average 3.0; Level 4 Reinforced Surgical Gown: Average 3.1
Air permeability (Level 3 Standard Surgical Gown): Average 40 ft³/min/ft²
EO/ECH Residue: EO:
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 21, 2021 Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K212869
Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA
Dear Diana Hong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on December 13, 2021. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: 301-796-0270 or Email: Clarence.Murrav@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fugou County Shenxiang Manufacturing Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K212869
Trade/Device Name: Disposable Surgical Gown, Disposable Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 19, 2021 Received: September 9, 2021
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.
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
2
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212869
Device Name
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Indications for Use (Describe)
Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|× Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K212869
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 12/13/2021
-
- Sponsor Identification
Fugou County Shenxiang Manufacturing Co., LTD. Industrial Clusters, No.2 Road, Fugou County, Henan Province, China
Establishment Registration Number: 3017149307
Contact Person: Carina Si Position: Business Manager Tel: +86- 21-54889822 Fax: +86- 21-54889180 Email: mike.xu(@fgshenxiang.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
5
Identification of Proposed Device 4.
Trade Name: Disposable Surgical Gown, Disposable Reinforced 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;
Indication for use:
Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
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.
There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
Table 1. Surgical Gowns Description
| Proposed | Model | Size | Color | Style | AAMI | Material |
|---|---|---|---|---|---|---|
| ---------- | ------- | ------ | ------- | ------- | ------ | ---------- |
2 / 13
6
| device | Level | |||||
|---|---|---|---|---|---|---|
| Disposable | ||||||
| Surgical | ||||||
| Gown | ML515M45U | S, M, L, XL, | ||||
| XXL, | ||||||
| XXXL | Blue | Non-reinforced | 3 | 45g/m² PP SMS | ||
| nonwoven, Polyester, | ||||||
| Blue masterbatch | ||||||
| GD524ME65 | S, M, L, XL, | |||||
| XXL, | ||||||
| XXXL | Blue | Non-reinforced | 4 | 45g/m² SMS | ||
| nonwoven, 20g/m² PE | ||||||
| film, Polyester, Blue | ||||||
| masterbatch | ||||||
| Disposable | ||||||
| Reinforced | ||||||
| Surgical | ||||||
| Gown | PA528ME45R | S, M, L, XL, | ||||
| XXL, | ||||||
| XXXL | Blue | Reinforced | 4 |
5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown
Predicate Device 2 510(k) Number: K192290 Product Name: SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Surgical Gown
Predicate Device 3 510(k) Number: K121152 Product Name: Surgical Gown
-
- Summary of Clinical Testing
No clinical study is included in this submission.
- Summary of Clinical Testing
7
7. Summary of Technological characteristics
| Item | Proposed Device | Predicate Device K211422 | Remark |
|---|---|---|---|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | Disposable Surgical Gown and | ||
| Disposable Reinforced Surgical | |||
| Gown 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, Disposable | |||
| Surgical Gown ML515M45U met | |||
| the requirements for Level 3 | |||
| classification, Disposable Surgical | |||
| Gown GD524ME65 and | |||
| Disposable Reinforced Surgical | |||
| Gown met the requirements of | |||
| Level 4 classification. | 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, the Level 2 | |||
| standard surgical gowns met the | |||
| requirements for Level 2 | |||
| classification, the Level 3 standard | |||
| surgical gowns and Level 3 | |||
| reinforced 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 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per square (g) | 45g/m2 | Level 3 Standard Surgical Gown: | |
| 43g/m² | Different | ||
| Size | S, M, L, XL, XXL, XXXL | XS, S, M, L, XL, XXL, XXXL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | >50 cm | Level 3 Standard Surgical | |
| Gown: >50 cm | Same | ||
| Water impact | 20N | >20N | Same |
| ----------------------------- | ----------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------- | ----------- |
| Tearing strength | >20N | >20N | Same |
| Linting | $Log_{10}30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection | |||
| level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | SMS, Polyester, Blue masterbatch | Level 3 Standard Surgical Gown: | |
| SMS nonwoven, Polyester and | |||
| Polyamide | Different | ||
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, | Under the conditions of the study, | Same |
| Irritation | the device is non-toxic, | ||
| non-irritating, and | the device is non-toxic, | ||
| non-irritating, and non-sensitizing. | |||
| Sensitization | non-sensitizing. | ||
| Sterilization | Sterile | ||
| Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level | |||
| (SAL): 10-6 | Sterile | ||
| Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level | |||
| (SAL): 10-6 | Same |
Different - Weight per square
The weight per square for the proposed surgical gowns is different from the predicate device. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection level 3 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 surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. And the specifications of the proposed device can be covered by the predicated products. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different- Material
The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
9
| Item | Proposed Device | Predicate Device K192290 | Predicate Device K121152 | Remark |
|---|---|---|---|---|
| Product Code | FYA | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | II | Same |
| Indication for Use | Disposable Surgical Gown and Disposable Reinforced Surgical Gown 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. | 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, SMS Standard Surgical Gown and SMS Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification. | Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This product may be sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135. | Same |
| Style | Non-reinforced/Reinforced | Non-reinforced | Reinforced | Different |
| Durability | Disposable | Disposable | Disposable | Same |
| Color | Blue | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per | Level 4 Standard Surgical | 68 g/m² | 45 g/m² | Different |
| square (g) | Gown: 45g/m² and 20g/m² | |||
| PE film | ||||
| Level 4 Reinforced Surgical | ||||
| Gown: 45g/m² and 25g/m² | ||||
| PE film reinforced film | ||||
| Size | S, M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL, | ||
| XXXL-XLONG | XL | Different | ||
| Flammability | Class I | Class I | Class I | Same |
| Hydrostatic | ||||
| pressure | Level 4 Standard Surgical | |||
| Gown: >50 cm; | ||||
| Level 4 Reinforced Surgical | ||||
| Gown: >50 cm | >50 cm | >20 | Same | |
| Water impact | ≤1.0 g | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | Level 4 Standard Surgical | |||
| Gown: | ||||
| latitude: 111 N | ||||
| longitude: 184 N | ||||
| Level 4 Reinforced Surgical | ||||
| Gown: | ||||
| latitude: 109 N | ||||
| longitude: 122 N | latitude: 92.3N | |||
| longitude: 177.11N | Passed | Different | ||
| Tearing strength | Level 4 Standard Surgical | |||
| Gown: | ||||
| latitude: 90 N | ||||
| longitude: 137 N | ||||
| Level 4 Reinforced Surgical | ||||
| Gown: | ||||
| latitude: 80 N | ||||
| longitude: 137 N | latitude: 35.30N | |||
| longitude: 56.46N | Passed | Different | ||
| Linting | Log10 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles; |
-
AATCC 127: 2017 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 F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
-
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
13
-
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;
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
ASTM F1671/F1671M-13 Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens
| Name of Testing
Methodology | Purpose | Acceptance
Criteria | Results |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Pass |
| 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 | Level 3 Standard Surgical
Gown:
Average 67cm;
Level 4 Standard Surgical
Gown:
Average 196cm;
Level 4 Reinforced Surgical
Gown:
Average 162cm |
| 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 | Level 3 Standard Surgical
Gown:
Average 0.011g;
Level 4 Standard Surgical
Gown:
Average 0.014g;
Level 4 Reinforced Surgical
Gown:
Average 0.017g |
| Breaking strength | The test was performed in | >20N | Level 3 Standard Surgical |
| | 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. | | Gown:
Latitude: average 96N;
Longitude: average 116N;
Level 4 Standard Surgical |
| | | | |
| 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. | >20N | Level 4 Standard Surgical
Gown:
Latitude: average 111N;
Longitude: average 184N;
Level 4 Reinforced Surgical
Gown:
Latitude: average 109N;
Longitude: average 122N |
| | | | Level 3 Standard Surgical
Gown:
Latitude: average 77N;
Longitude: average 128N;
Level 4 Standard Surgical
Gown:
Latitude: average 90N;
Longitude: average 137N;
Level 4 Reinforced Surgical
Gown:
Latitude: average 80N;
Longitude: average 137N |
| 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) 30 ft³/min/ft² | Level 3 Standard Surgical
Gown:
Average 40 ft³/min/ft² |
| EO/ECH Residue | | | |
| | The test was performed in
accordance with ISO
10993-7:2008 Biological
evaluation of medical
devices - Part 7: Ethylene
oxide sterilization residuals
to evaluate the level of
sterilant residues. | Level 3 Standard Surgical
Gown:
EO: