← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K233183 # Surgical Gown (40083) (K233183) _Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · FYA · Feb 1, 2024 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K233183 ## Device Facts - **Applicant:** Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Feb 1, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile. ## Device Story Surgical gown (model 40083) designed for use by operating room personnel; provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Constructed from SSMMS non-woven material with cotton cuffs; available in multiple sizes (XS-3XL). Device is single-use, disposable, and provided sterile. Functions as a physical barrier; performance verified via standardized bench testing for seam strength, breaking strength, tear strength, lint generation, flammability, and water penetration resistance. No clinical data included. ## Clinical Evidence No clinical data. Bench testing only. Performance verified against ANSI/AAMI PB70:2012, ASTM D1683M-17, ASTM D5034-09, ASTM D5587-15, ISO 9073-10, and CPSC 16 CFR 1610. Biocompatibility confirmed per ISO 10993-5, 10993-10, and 10993-23. ## Technological Characteristics Materials: SSMMS non-woven body/sleeve/belt, cotton cuffs. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Standards: ASTM D5587-15 (tear), ASTM D5034-09 (breaking), ASTM D1683M-17 (seam), ISO 9073-10 (lint), CPSC 16 CFR 1610 (flammability), AATCC 42/127 (water resistance). Sterilization: Ethylene Oxide (EO) per ISO 10993-7. ## 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 XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD ([K231510](/device/K231510.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). On the left is the Department of Health & Human Services 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. February 1, 2024 Ammex-Weida (Hubei) Health and Safety Products Co., Ltd % Jarvis Wu Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China Re: K233183 Trade/Device Name: Surgical Gown (40083) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 29, 2023 Received: December 29, 2023 Dear Jarvis Wu: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Bifeng Qian -S 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233183 Device Name Surgical Gown (40083) #### Indications for Use (Describe) Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile. | 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) | #### 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." {4}------------------------------------------------ # 510(K) Summary K233183 Document prepared date: 2024/1/30 ## A. Applicant: Name: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Address: Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei China, 433011 Contact Person: Melody Wang Tel: +86 13476816925 Mail: office@hborient.com Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122. China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com ### B. Device: Trade Name: Surgical Gown Common Name: Surgical Gown Model(s): 40083 Regulatory Information Classification Name: Gown. Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel ## C. Predicate device: K231510 Surgical Gown XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD #### D. Intended use /Indications for Use: Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile. {5}------------------------------------------------ # E. Device Description: The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color. | Table 1 General Comparison | | | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Device | Proposed Device | Predicate Device | Remark | | Manufacturer | Ammex-Weida (Hubei) Health and
Safety Products Co., Ltd | XIANTAO ZHIBO NON-WOVEN
PRODUCTS CO.,LTD. | - | | 510K number | K233183 | K231510 | - | | Product
Name | Surgical Gown | Surgical Gown | Same | | Classification | Class II Device, FYA (21
CFR878.4040) | Class II Device, FYA
(21CFR878.4040) | Same | | Intended use
/Indications
for Use | Surgical Gowns are intended to be
worn by operating room personnel
during surgical procedures to protect
the surgical patient and operating
room personnel from the transfer of
microorganisms, body fluids and
particulate material. This surgical
gown meets the requirements of
AAMI Level 3 barrier protection for
a surgical gown per ANSI/AAMI
PB70:2012 Liquid barrier
performance and classification of
protective apparel and drapes
intended for use in health care
facilities (AAMI PB70). The
Surgical Gowns are single use,
disposable medical devices,
provided sterile. | Surgical Gown is intended to be
worn by room personnel during
surgical procedures or other invasive
tests to protect both the surgical
patient and operating room
personnel from the transfer of
microorganisms, body fluids and
particulate material. This is single
use, disposable device, provided
sterile.
Per ANSI/AAMI PB70:2012 Liquid
barrier performance and
classification of protective apparel
and drapes intended for use in health
care facilities, the Surgical Gown
met the requirements for Level 3
classification. | Same | | Style | Non-reinforced | Non-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 | | Item | Proposed Device(K233183) | Predicate Device(K231510) | Remark | | Size | XS, S, M, L, XL, 2XL, 3XL | S, M, L, XL, XXL, XXXL | Different.
resolved by
performance
testing | | Weight per
square(g) | 45 g/m2 | 50 g/m2 | Different.
No affect on
safety or
efficacy | | Hydrostatic
Pressure(cm)
AATCC-127 | >50 cm | >50 cm | Same | | Water impact
AATCC-42 | ≤1.0 g | ≤1.0 g | Same | | Breaking
strength | MD: 120.61N
CD: 88.19N | MD: 144.87N
CD: 88.89N | Similar | | Tearing
strength | MD: 60.03N
CD: 39.78N | MD: 69.61N
CD: 32.25N | Similar | | Seam
Strength | >30N | >30N | Same | | Flammability | Class I | Class I | Same | | EO residue | EO ≤ 4mg/d
ECH ≤ 9mg/d | EO ≤ 4mg/d
ECH ≤ 9mg/d | Same | | Shelf life | 3 years | 3 years | Same | | Barrier
protection level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same | | Material | SSMMS non-woven, Cotton,
and Nylon + polyester | SMMS non-woven, Cotton, and Nylon | Different | | Biocompatibility | Under the conditions of the study, the device extract was not cytotoxic.
Under the conditions of the study, the non-polar and polar device
extracts were not found to be an irritant.
Under conditions of the study, the non-polar and polar device
extracts were not found to be a sensitizer. | | Same | ## F. Comparison with predicate device Table 1 General Comparison {6}------------------------------------------------ Table 2 Safety and Performance Comparison # Analysis The weight per square (g) ,size and material are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard. Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the material. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier {7}------------------------------------------------ Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns. # G. Summary of Non-Clinical Tests Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints. | Test Item | Test standard | Acceptance Criteria | Result | |------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Seam strength
ASTM D1683M-
17 Standard Test
Method for
Failure in Sewn
Seams of Woven
Fabrics. | The test was performed
In accordance with
ASTM D1683M-17
Standard. Test Method
for Seam Strength of
Textile Fabrics (Grab
Test) to evaluate Failure
in Sewn Seams of the test
sample. | ≥30N(7lbf)
per standard
F2407-20 for level 3 | PASS
68.46 N
(Average result from 30
samples) | | Breaking
strength
ASTM D5034-09
(2017)
Standard Test
Method for
Breaking Strength
and Elongation of
Textile Fabrics
(Grab Test) | The test was performed
In accordance with
D5034-09 (2017) .
Standard. Test Method
for Breaking Strength
and Elongation of Textile
Fabrics (Grab Test) to
evaluate the breaking
strength of the test
sample. | ≥30N(7lbf)
per standard
F2407-20 for level 3 | PASS
MD: 120.61N
CD: 88.19N
(Average result from 30
samples) | | Tear strength(N)
ASTM D5587-15,
Standard Test
Method for
Tearing Strength
of Fabrics by
Trapezoid
Procedure | 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 | PASS
MD: 60.03N
CD: 39.78N
(Average result from 30
samples) | | Lint and other
generation in the
dry state
ISO 9073-
10:2003(E) | 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. | Log10(particle count)
< 4 | PASS
1.9
(Average result from 6
samples ) | | Flammability
CPSC 16 CFR | The test was performed
in accordance with 16 | Class I | PASS | | Part
1610-2008,
Standard for the
Flammability of
clothing textiles | CFR Part 1610 Standard
for the Flammability of
Clothing Textiles to
evaluate the flammability
of the test sample. | | Class I | | Water
Penetration
Resistance
AATCC 42-2013,
Impact
Penetration Test | The test was performed
in accordance with
AATCC 42: 2013
Water Resistance: Impact
Penetration Test to
evaluate the water impact
of the test sample. | ≤1.0g AQL: 4%
Level 3 per standard
ANSI/AAMI
PB70:2012 for level 3 | PASS
≤1.0g | | Static
hydrostatic
resistance
AATCC 127-
2014,
Water Resistance:
Hydrostatic
Pressure Test; | The test was performed
in accordance with
AATCC 127: 2014
Water Resistance:
Hydrostatic Pressure Test
to determine the
hydrostatic pressure of
the test sample. | ≥50 cmH2O per
standard ANSI/AAMI
PB70:2012 for level 3 | PASS
≥50 cm | | EO and ECH
sterilization
residual
ISO 10993-
7:2008
Ethylene oxide
sterilization
residuals | The test was performed
in accordance with ISO
10993-7:2008 Ethylene
oxide sterilization
residuals to determine the
EO and ECH residuals of
the test sample. | EO ≤ 4mg/d
ECH ≤ 9mg/d | PASS
EO ≤ 4mg/d
ECH ≤ 9mg/d | | Cytotoxicity
ISO 10993-5
Biological
evaluation of
medical devices
- Part 5: Tests
for in vitro
cytotoxicity | The test was performed
in accordance with ISO
10993-5 to determine
cytotoxicity of the test
sample | Non-Cytotoxic | PASS
Under the conditions of the
study, the device is non-
cytotoxic. | | Irritation
ISO 10993-23
Biological
evaluation of
medical devices -
Part 23: Tests for
irritation | The test was performed
in accordance with ISO
10993-23 to determine
Irritation of the test
sample | Non-Irritating | PASS
Under the conditions of the
study, the device is non-
irritating. | | Sensitization
ISO 10993-10
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Sensitization | The test was performed
in accordance with ISO
10993-10 to determine
skin sensitization of the
test sample | Non-Sensitizing | PASS
Under the conditions of the
study, the device is non-
sensitizing | {8}------------------------------------------------ Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei,China, 433011 {9}------------------------------------------------ ## H. Summary of Clinical Test No clinical study is included in this submission. ## I. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device proposed in this 510(k) is safe, as effective, and performs as well as or better than the legally marketed predicate device under K231510. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K233183](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K233183) **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