← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K211422 # Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (K211422) _Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · FYA · Jul 2, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K211422 ## Device Facts - **Applicant:** Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Jul 2, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended 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 Story Single-use, disposable surgical gowns; available in Level 2 standard, Level 3 standard, and Level 3 reinforced configurations. Used by operating room personnel to provide barrier protection against microorganisms, body fluids, and particulates during surgical procedures. Gowns are provided sterile. Protection levels verified per ANSI/AAMI PB70:2012. Available in seven sizes (XS-XXXL). ## Clinical Evidence No clinical data. Bench testing only. Performance verified via flammability (16 CFR 1610), hydrostatic pressure (AATCC 127), water impact (AATCC 42), breaking strength (ASTM D5034), tearing strength (ASTM D5587), linting (ISO 9073-10), and air permeability (ASTM D737). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10. ## Technological Characteristics Materials: SMS nonwoven, polyester, polyamide, and hydrophilic nonwoven. Sterilization: Ethylene Oxide (EO) to SAL 10⁻⁶. Barrier performance: AAMI Level 2 and 3 per ANSI/AAMI PB70:2012. Standards: 16 CFR 1610 (flammability), AATCC 127/42 (liquid barrier), ASTM D5034/D5587 (strength), ISO 9073-10 (linting), ASTM D737 (air permeability), ISO 10993 (biocompatibility). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Surgical Gown ([K172987](/device/K172987.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) K211422 ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {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 - 1. Date of Preparation: 06/24/2021 - 2. 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 - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person) ## 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) <4 | Log10(particle count) <4 | Same | | | Air permeability | >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) < 4 | Level 2 Standard Surgical
Gown: 2.85;
Level 3 Standard Surgical
Gown: 2.85;
Level 3 Reinforced Surgical
Gown: 2.86 | | Air
permeability | The test was performed
in accordance with
ASTM D737: 2018
Standard Test Method
for Air Permeability of
Textile Fabrics to
evaluate the air
permeability of the test
sample. | >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: < 4 mg/device
ECH: < 9 mg/device | Level 2 Standard Surgical
Gown: 0.22 mg/device EO
0.08 mg/device ECH
Level 3 Standard Surgical
Gown: 0.22 mg/deviceEO
0.12 mg/device ECH
Level 3 Reinforced Surgical
Gown: 0.35 mg/device EO
0.24 mg/device ECH | {9}------------------------------------------------ | Name of
Testing
Methodology | Purpose | Acceptance Criteria | Results | | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------| | Cytotoxicity | The test was performed
in accordance with ISO
10993-5: 2009
Biological Evaluation of
Medical Devices-Part 5:
Tests for in Vitro
Cytotoxicity to evaluate
the cytotoxicity of the
test sample. | Non-cytotoxic | Under the conditions of the
study, the device
is non-cytotoxic. | | | | | Irritation | The test was performed
in accordance with ISO
10993-10: 2010
Biological Evaluation of
Medical Devices-Part
10: Tests for Irritation
and Skin Sensitization to
evaluate the irritation of
the test sample. | Non-irritating | Under the conditions of the
study, the device is non-
irritating. | | | | | Sensitization | The test was performed
in accordance with ISO
10993-10: 2010
Biological Evaluation of
Medical Devices-Part
10: Tests for Irritation
and Skin Sensitization to
evaluate the
sensitization of the test
sample. | Non-sensitizing | Under the conditions of the
study, the device is non-
sensitizing. | Table 4 Summary of Biocompatibility Testing - 8. Clinical Test Conclusion No clinical study is included in this submission. ### 9. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device K172987. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K211422](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K211422) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com