(209 days)
No
The device description and performance studies focus solely on the physical barrier properties and material characteristics of a surgical gown, with no mention of AI or ML.
No
A therapeutic device is one that treats or alleviates a medical condition. This device, a surgical gown, is for protection and barrier purposes, not treatment.
No
Explanation: The device is a high protection surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its function is to provide a barrier and does not involve diagnosing medical conditions.
No
The device description clearly states it is a "single use, disposable medical device" and describes physical characteristics like sizes and barrier protection levels, indicating it is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "High protection surgical gown" intended to be worn by operating room personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a barrier device used during a medical procedure, not a device used to diagnose a condition in vitro (outside the body).
- Device Description: The description reinforces that it's a "single use, disposable medical device" worn by personnel for protection.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide any diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties and barrier performance (flammability, hydrostatic pressure, breaking strength, resistance to penetration, etc.), which are relevant to protective apparel, not diagnostic tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
High protection 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 high protection surgical gown met the requirements for Level 4 classification.
Product codes
FYA
Device Description
The proposed device 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. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel during surgical procedure / 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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
- AATCC 42: 2017 Water Resistance: Impact Penetration Test;
- ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
- ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
- ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
- ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System;
- ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residues;
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
Key Metrics
- Flammability: Class 1
- Hydrostatic pressure: 204.6 cm H2O (Acceptance Criteria: ≥50 cm H2O)
- Water impact: 0.02g (Acceptance Criteria: ≤1.0 g)
- Breaking strength: Longitude:131.5N, Latitude:75.2N (Acceptance Criteria: ≥30 N)
- Tearing strength: Longitude:79.0N, Latitude:33.8N (Acceptance Criteria: ≥10 N)
- Linting: Side A:3.1, Side B:3.2 (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.
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 12, 2023
3A Medical Products Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K222456
Trade/Device Name: High Protection Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 6, 2023 Received: February 8, 2023
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.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222456
Device Name High Protection Surgical Gown
Indications for Use (Describe)
High protection 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 high protection surgical gown met the requirements for Level 4 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."
3
510(k) Summary K222456
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222456
-
- Date of Preparation: 02/07/2023
-
- Sponsor Identification
ЗА MEDICAL PRODUCTS СО., LTD
Yuan Industrial Park, Liuan City, China 237100 Establishment Registration Number: 3013735189
Contact Person: Amy Ma Position: Sales Director Tel: 86-551-64456982 Fax: 86-551-6556979 Email: info@3a-medical.cn
-
- 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: High Protection 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:
High protection 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 high protection surgical gown met the requirements for Level 4 classification.
Device Description:
The proposed device 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. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
-
- Identification of Predicate Device
510(k) Number: K212869
- Identification of Predicate Device
Product Name: Disposable Surgical Gown ML515M45U Disposable Surgical Gown GD524ME65 (Selected as the predicate device) Disposable Reinforced Surgical Gown
-
- Identification of Reference Device
5
510(k) Number: K221819 Product Name: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown; 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown (Sterile status was selected as the reference device)
-
Summary of Non-Clinical Test 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
-
A AATCC 42: 2017 Water Resistance: Impact Penetration Test;
-
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
-
ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
-
ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
-
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
-
ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System;
-
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
-
ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
6
| Test
Methodology | Purpose | Acceptance
Criteria | Result |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
requirements | Class 1 |
| Hydrostatic
pressure | The test was performed in accordance
with AATCC 127: 2017 Water
Resistance: Hydrostatic Pressure Test
to determine the hydrostatic pressure
of the test sample. | ≥50 cm H2O | 204.6 cm H2O |
| Water impact | The test was performed in accordance
with AATCC 127: 2017 Water
Resistance: Hydrostatic Pressure Test
to determine the hydrostatic pressure
of the test sample. | ≤1.0 g | 0.02g |
| Breaking
strength | The test was performed in accordance
with ASTM D 5034:2009(2017)
Standard Test Method for Breaking
Strength and Elongation of Textile
Fabrics (Grab Test) to evaluate the
breaking strength of the test sample. | ≥30 N | Longitude:131.5N
Latitude:75.2N |
| 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. | ≥10 N | Longitude:79.0N;
Latitude:33.8N |
| Linting | The test was performed in accordance
with ISO 9073-10:2003 Textiles-Test
Methods for Nonwovens-Pat 10: Lint
and Other Particles Generation in the
Dry State to evaluate the linting of
the test sample. | Log10(particle
count) 50 cm H2O | | >50 cm H2O | Same |
| Water impact | ≤1.0 g | ≤1.0 g | | ≤1.0 g | Same |
| Breaking strength | Longitude:131.5N
Latitude:75.2N | Longitude: 184 N
Latitude: 111 N | | Longitude: 237.72 N
Latitude: 148.93N | Different |
| Tearing strength | Longitude:79.0N;
Latitude:33.8N | Longitude: 137 N
Latitude: 90 N | | Longitude: 53.98 N
Latitude: 49.23N | Different |
| Linting | Log10