(98 days)
Not Found
No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.
No
A surgical gown is a protective barrier, not a device intended to treat or manage a disease or condition. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material.
No
Explanation: The device, a surgical gown, is intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. It does not diagnose, treat, or prevent a disease or condition by providing information through analysis.
No
The device description clearly states the device is a physical surgical gown made of non-woven material and cotton, with physical properties and performance metrics related to barrier protection and material strength. 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 operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures or other invasive tests. This is a barrier function for personal protection.
- Device Description: The device is a surgical gown made of non-woven material and cotton, with some models having reinforcement. It's a physical barrier.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on physical properties like flammability, liquid barrier performance (hydrostatic pressure, water impact), strength, linting, and biocompatibility (cytotoxicity, irritation, sensitization). These are all related to the gown's function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. It doesn't involve testing or analyzing biological samples.
In summary, the device is a medical device intended for personal protection in a healthcare setting, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 2 classification, and the 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 Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.
The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL 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.
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
room personnel during surgical procedures or other invasive tests / 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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:
- A 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
- A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
- A AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
- A AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test;
-
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
-
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective A Apparel and Drapes Intended For Use In Health Care Facilities.
Flammability:
Purpose: 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.
Acceptance Criteria: Meets Class 1 requirements
Results: PASS, Surgical Gown: Class 1, Reinforced Surgical Gown: Class 1
Hydrostatic pressure:
Purpose: The test was performed in accordance with AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test to determine the hydrostatic pressure of the test sample.
Acceptance Criteria: Surgical Gown (Level 2): >20cm; Reinforced Surgical Gown (Level 3): >50 cm
Results: PASS, Surgical Gown: 60cm, Reinforced Surgical Gown: 95cm
Water impact:
Purpose: The test was performed in accordance with AATCC 42: 2017 Water Resistance: Impact Penetration Test to evaluate the water impact of the test sample.
Acceptance Criteria: ≤1.0 g
Results: PASS, Surgical Gown: 0.1g, Reinforced Surgical Gown: 0g
Breaking strength:
Purpose: 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.
Acceptance Criteria: >20N
Results: PASS, Surgical Gown: 124N, Reinforced Surgical Gown: 123N
Tearing strength:
Purpose: 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.
Acceptance Criteria: >20N
Results: PASS, Surgical Gown: 52N, Reinforced Surgical Gown: 61N
Linting:
Purpose: 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.
Acceptance Criteria: Log10(particle count)
§ 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.
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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.
December 15, 2021
Wuhan Zonsen Medical Products Co.,Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K212861
Trade/Device Name: Surgical Gown, Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 8, 2021 Received: September 8, 2021
Dear Ivy Wang:
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K212861
Device Name Surgical Gown, Reinforced Surgical Gown
Indications for Use (Describe)
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 2 classification, and the 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
SECTION 5
4
Wuhan Zonsen Medical Products Co.,Ltd No 8 Jinchao Road Zhucheng Street Xinzhou District Wuhan City Hubei Province, China,431400
510(K) Summary K212861
Document prepared date: 2021/12/13
A. Applicant:
Wuhan Zonsen Medical Products Co.,Ltd Address: No.8 Jinchao Road Zhucheng Street Xinzhou District Wuhan City Hubei Province, China, 431400 Contact Person: Cynthia Ye Tel : +86 02782737771
Submission Correspondent: ` Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Gown, Reinforced Surgical Gown Common Name: Surgical Gown Model(s): ZSG1005, ZSG1006
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
D. Intended use of the device:
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.
5
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 2 classification, and the reinforced surgical gown met the requirements for Level 3 classification.
E. Device Description:
The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.
The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL 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.
F. Comparison with predicate device
| Device | Predicate Device | Proposed Device | Remark |
|---|---|---|---|
| Manufacturer | Jiangsu Medplus Non-woven | ||
| Manufacturer Co., Ltd. | Wuhan Zonsen Medical Products | ||
| Co.,Ltd | - | ||
| 510K number | K211422 | K212861 | - |
| Model Name | Level 2 Standard Surgical Gown, | ||
| Level 3 Standard Surgical Gown, | |||
| Level 3 Reinforced Surgical Gown | Surgical Gown, | ||
| Reinforced Surgical Gown, | - | ||
| Classification | Class II Device, FYA (21 | ||
| CFR878.4040) | Class II Device, FYA | ||
| (21CFR878.4040) | Same | ||
| Intend use | Surgical gown is intended to be | ||
| worn by operating room personnel | |||
| during surgical procedure to | |||
| protect both the surgical patient | |||
| and the operating room personnel | |||
| from transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. | Surgical Gown is intended to be | ||
| worn by 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. | Similar. | ||
| No issues | |||
| of safety or | |||
| efficacy | |||
| raised. | |||
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Use | Single Use; Disposable; Sterile | Single Use; Disposable; Sterile | Same |
| Color | Blue | Blue | Same |
Table 1 General Comparison
6
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
|---|---|---|---|
| ---------- | ----------------------------- | ----------------------------- | ------ |
Table 2 Safety and Performance Comparison
| Item | Predicate Device | Proposed Device | Remark |
|---|---|---|---|
| Weight per square (g) | Level 2 Standard Surgical Gown: 35g/m2; | ||
| Level 3 Standard Surgical Gown: 43g/m2 | |||
| Level 3 Reinforced Surgical Gown: 35g/m2 and 28g/m2 | Surgical Gown: 45g/ m2; | ||
| Reinforced Surgical Gown: 45g/m2 | Difference resolved by performance testing | ||
| Size | XS, S, M, L, XL, XXL, XXXL | M, L, XL | Different. No affect on safety or efficacy |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | Level 2 Standard Surgical Gown: >20 cm; | ||
| Level 3 Standard Surgical Gown: >50 cm; | |||
| Level 3 ReinforcedSurgical Gown: >50 cm | Surgical Gown: >20 cm; | ||
| Reinforced Surgical Gown: >50 cm | Same | ||
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Linting | Log10(particle count) ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test); |
-
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective A Apparel and Drapes Intended For Use In Health Care Facilities.
| Name of | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Testing | |||
| Methodology | |||
| 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 | ||
| Surgical Gown: | |||
| Class 1 | |||
| Reinforced | |||
| Surgical Gown: | |||
| Class 1 | |||
| The test was performed in accordance | |||
| with AATCC 127: 2017 Water | |||
| Resistance: Hydrostatic Pressure Test to | Surgical Gown | ||
| (Level2): >20cm; | PASS | ||
| Surgical Gown: |
Table 3 Performance Testing
8
| determine the hydrostatic pressure of | 60cm | ||
|---|---|---|---|
| Hydrostatic | |||
| pressure | the test sample. | Reinforced | |
| Surgical Gown | |||
| (Level 3): >50 cm | Reinforced | ||
| Surgical Gown: | |||
| 95cm | |||
| 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 | PASS | |
| Surgical Gown: | |||
| 0.1g | |||
| Reinforced | |||
| Surgical | |||
| Gown:0g | |||
| 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 | PASS | |
| Surgical Gown: | |||
| 124N | |||
| Reinforced | |||
| Surgical Gown: | |||
| 123N | |||
| 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 | PASS | |
| Surgical Gown: | |||
| 52N | |||
| Reinforced | |||
| Surgical | |||
| Gown:61N | |||
| 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) |