(56 days)
Not Found
No
The 510(k) summary describes a standard surgical gown and its barrier properties, with no mention of AI or ML technology in its intended use, device description, or performance studies.
No.
The device functions as a barrier to prevent the transfer of contaminants, it does not treat or cure any medical condition.
No
This device is a surgical gown, which is personal protective equipment intended to prevent the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly identifies the device as a physical surgical gown, a single-use, disposable medical device made of material intended to provide a barrier. There is 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 surgical patients and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and barrier performance of the gowns.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies focus on physical properties and biocompatibility, not diagnostic accuracy or clinical performance related to diagnosing a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. Surgical gowns, while medical devices, serve a different purpose related to infection control and protection.
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, 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.
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.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
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 testing was performed to demonstrate that the subject devices meet acceptance criteria in the standard.
Flammability:
- Purpose: Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.
- Acceptance Criteria: Meets Class 1 requirements.
- Results: Pass.
Hydrostatic pressure:
- Purpose: Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test.
- Acceptance Criteria: Level 2 Standard Surgical Gown: >20 cm; Level 3 Standard Surgical Gown: >50 cm; Level 3 Reinforced Surgical Gown: >50 cm.
- Results: Level 2 Standard Surgical Gown: 37.6 cm; Level 3 Standard Surgical Gown: 52.6 cm; Level 3 Reinforced Surgical Gown: 83.1 cm.
Water impact:
- Purpose: Evaluate the water impact of the test sample in accordance with AATCC 42: 2017 Water Resistance: Impact Penetration Test.
- Acceptance Criteria: 20N.
- Results: Level 2 Standard Surgical Gown: 73N; Level 3 Standard Surgical Gown: 70.3N; Level 3 Reinforced Surgical Gown: 45.6N.
Tearing strength:
- Purpose: Evaluate the tearing strength of the test sample in accordance with ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure.
- Acceptance Criteria: >20N.
- Results: Level 2 Standard Surgical Gown: 24.1N; Level 3 Standard Surgical Gown: 48.4N; Level 3 Reinforced Surgical Gown: 24.6N.
Linting:
- Purpose: Evaluate the linting of the test sample in accordance with ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State.
- Acceptance Criteria: Log10(particle count) 30 ft^3/min/ft^2.
- Results: Level 2 Standard Surgical Gown: 32.9 ft^3/min/ft^2; Level 3 Standard Surgical Gown: 33.8 ft^3/min/ft^2; Level 3 Reinforced Surgical Gown: 31.7 ft^3/min/ft^2.
EO/ECH Residue:
- Purpose: Evaluate the level of sterilant residues in accordance with ISO 11135:2014 Annex B.
- Acceptance Criteria: 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
July 2, 2021
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, Jiangsu 200120 China
Re: K211422
Trade/Device Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: April 8, 2021 Received: May 7, 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.
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 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.
Clarence W. Murray, III, PhD 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)
Device Name
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced 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, the Level 2 standard surgical gowns met the requirements for Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211422
-
- Date of Preparation: 06/24/2021
-
- Sponsor Identification
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone, Siyang, Jiangsu, 223700, China.
Establishment Registration Number: 3017194442
Contact Person: Shuying An Position: Product Manager Tel: +86-527-80300123 Fax: +86-527-80300123 Email: zongzhu@medplusgroup.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: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 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:
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.
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 three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
5. Identification of Predicate Device
5
510(k) Number: K172987 Product Name: Surgical Gown
6. Comparison of Technological characteristics
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device K211422 | Predicate Device K172987 | Remark |
| 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. | ||
| 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. | 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 AE series surgical gowns met the requirements for Level 2 classification, the AG series surgical gowns met the requirements for Level 3 classification. | Same | ||
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
Table 1 General Comparison
| Table 2 Safety and Performance Comparison | |
|---|---|
| Item | Proposed Device | Reference Device K172987 | Remark | |
|---|---|---|---|---|
| Weight | ||||
| square (g) | per | Level 2 Standard Surgical Gown: | ||
| 35g/m²; | ||||
| Level 3 Standard Surgical Gown: | 44g/m² | Different | ||
| 43g/m² | ||||
| Level 3 Reinforced Surgical Gown: | ||||
| 35g/m² and 28g/m² | ||||
| Size | XS, S, M, L, XL, XXL, XXXL | XL | Different | |
| Flammability | Class I | Class I | Same | |
| Hydrostatic | ||||
| pressure | Level 2 Standard Surgical | |||
| Gown: >20 cm; | ||||
| Level 3 Standard Surgical | ||||
| Gown: >50 cm; | ||||
| Level 3 Reinforced Surgical | ||||
| Gown: >50 cm | AE series: >20 cm; | |||
| AG series: >50 cm | Same | |||
| Water impact | ≤1.0 g | ≤1.0 g | Same | |
| Breaking | ||||
| strength | >20N | >20N | Same | |
| Tearing strength | >20N | >30N | Different | |
| 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 | 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 | SMMMS, Polypropylene, | |||
| Polyethylene, Polyester | Different | |||
| Biocompatibility | ||||
| Cytotoxicity | ||||
| Irritation | ||||
| Sensitization | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Same | |
| Sterilization | Sterile | |||
| Method: Ethylene Oxide (EO); | ||||
| Sterilization Assurance Level | ||||
| (SAL): 10⁻⁶ | Non-sterile | Different |
Page 3 of 7
6
7
510(k) Summary
7. Summary of non-clinical testing
The following performance and biocompatibility testing data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard
| 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. | Level 2 Standard | ||
| Surgical Gown: >20 | |||
| cm; | |||
| Level 3 Standard | |||
| Surgical Gown: >50 | |||
| cm; | |||
| Level 3 Reinforced | |||
| Surgical Gown: >50 cm | Level 2 Standard Surgical Gown: | ||
| 37.6 cm; | |||
| Level 3 Standard Surgical Gown: | |||
| 52.6 cm; | |||
| Level 3 Reinforced Surgical Gown: | |||
| 83.1 cm | |||
| Water impact | The test was performed in | ||
| accordance with AATCC | |||
| 42: 2017 Water | |||
| Resistance: Impact | |||
| Penetration Test to | |||
| evaluate the water impact | |||
| of the test | |||
| sample. | ≤1.0 g | Level 2 Standard Surgical Gown: | |
| 0.4 g; | |||
| Level 3 Standard Surgical Gown: | |||
| 0.5 g; | |||
| Level 3 Reinforced Surgical Gown: | |||
| 0.2 g | |||
| Breaking | |||
| strength | The test was performed | ||
| in accordance with | |||
| ASTM D5034: | |||
| 2009(2017) Standard | |||
| Test Method for | |||
| Breaking Strength and | |||
| Elongation of Textile | |||
| Fabrics (Grab Test) to | |||
| evaluate the breaking | |||
| strength of the test | |||
| sample. | >20N | Level 2 Standard Surgical | |
| Gown: 73N; | |||
| Level 3 Standard Surgical | |||
| Gown: 70.3N; | |||
| Level 3 Reinforced Surgical Gown: | |||
| 45.6N |
| Table 3 Summary of Performance Testing |
|---|
| ---------------------------------------- |
Page 5 of 7
8
| 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 2 Standard Surgical
Gown: 24.1N;
Level 3 Standard Surgical
Gown: 48.4N;
Level 3 Reinforced Surgical
Gown: 24.6N |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Linting | The test was performed
in accordance with ISO
9073-10: 2003
Textiles-Test Methods
for Nonwovens-Part 10:
Lint and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample. | $Log_{10}$ (particle count) 30 ft3/min/ft2 | Level 2 Standard Surgical
Gown: 32.9 ft3/min/ft2;
Level 3 Standard Surgical
Gown: 33.8 ft3/min/ft2;
Level 3 Reinforced Surgical
Gown: 31.7 ft3/min/ft2 |
| EO/ECH
Residue | The test was performed
in accordance with
ISO 11135:2014 Annex
B to evaluate the level of
sterilant residues. | EO: