(90 days)
No
The device description and performance studies focus on material properties and barrier protection, with no mention of AI or ML.
No
The device is a disposable surgical gown intended for protection, not for treating or diagnosing a disease or condition.
No
The device description indicates that it is a disposable surgical gown, intended to protect from transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device is a disposable surgical gown, which is a physical product and not software. The summary describes physical characteristics and performance testing related to barrier protection and material properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Description: The description clearly states the device is a "Disposable 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 on the body, not a device used to test samples from the body.
- Intended Use: The intended use is for protection during surgical procedures, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, based on the provided information, this device is a medical device, specifically a surgical gown, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable 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 disposable surgical gowns met the requirements for Level 3 classification.
Product codes
FYA
Device Description
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are two types of disposable surgical gown: standard disposable surgical gown, reinforced disposable surgical gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for standard and reinforce disposable surgical gown meet AAMI Level 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical 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 D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
- ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
- 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;
- ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flammability: Class I
Hydrostatic pressure: Standard Disposable Surgical Gown: >50 cm; Reinforced Disposable Surgical Gown: >50 cm
Water impact: 20N
Tearing strength: >20N
Linting: Log1030 ft³/min/ft²
Barrier protection level: Level 3 per AAMI PB 70
Biocompatibility: Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing.
Sterilization Assurance Level (SAL): 10-6
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains 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.
December 13, 2021
Henan Robestain Medical Products Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K212925
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 16, 2021 Received: September 14, 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-reporting-
mdr-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).
Sincerely.
For 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) K212925
Device Name Disposable Surgical Gown
Disposable 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 disposable surgical gowns met the requirements for Level 3 classification.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K212925
-
- Date of Preparation: 11/23/2021
-
- Sponsor Identification
Henan Robestain Medical Products Co., Ltd
No.590, Zhangnan Industry Zone, Zhangsanzhai Town, Changyuan County, Henan Province, China Establishment Registration Number: 3017195371
Contact Person: Yonghong Liu Position: Quality Manager Tel: +86-373-8701888 Email: echo@robestain.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Disposable 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;
Indications for Use:
Disposable 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 disposable 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 two types of disposable surgical gown: standard disposable surgical gown, reinforced disposable surgical gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for standard and reinforce disposable surgical gown meet AAMI Level 3.
న్. Identification of Predicate Device
510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown (used as Predicate Device)
5
Level 3 Reinforced Surgical Gown (used as Predicate Device)
-
- Non-Clinical Test Conclusion
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:
- Non-Clinical Test Conclusion
-
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 D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
-
ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
-
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;
-
ISO 10993-1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Summary of Technological characteristics
| Item | Proposed Device | Predicate Device K211422 | Remark |
|---|---|---|---|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication | |||
| for | |||
| Use | Disposable 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 disposable
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 Level 3
standard surgical gowns and
Level 3 reinforced 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 |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Table 1 General Comparison | |
|---|---|
| Table 2 Safety and Effectiveness Comparison | |
|---|---|
| Item | Proposed Device | Reference Device K211422 | Remark |
|---|---|---|---|
| Weight per | |||
| square (g) | 45 g/m² | Level 3 Standard Surgical Gown: | |
| 43g/m² | |||
| Level 3 Reinforced Surgical | |||
| Gown: 35g/m² and 28g/m² | Different | ||
| Size | S, M, L, XL, XXL, XXXL | XS, S, M, L, XL, XXL, XXXL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic | |||
| pressure | Standard Disposable Surgical | ||
| Gown: >50 cm | Level 3 Standard Surgical | ||
| Gown: >50 cm; | Same |
4 / 6
7
| Reinforced Disposable Surgical Gown: >50 cm | Level 3 Reinforced Surgical Gown: >50 cm | ||
|---|---|---|---|
| Water impact | ≤0.42 g | ≤1.0 g | Different |
| Breaking strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Linting | Log1030 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | Standard disposable Surgical Gown: SMMS nonwoven, Polyester | ||
| Reinforced disposable Surgical Gown: SMMS nonwoven, PE Breathable Film, Polyester | Level 3 Standard Surgical Gown: SMS nonwoven, Polyester and Polyamide; | ||
| Level 3 Reinforced Surgical Gown: SMS nonwoven, Polyester, Polyamide and Hydrophilic nonwoven | Different | ||
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, | Under the conditions of the study, | |
| Irritation | the device is non-toxic, non-irritating, and non-sensitizing. | the device is non-toxic, non-irritating, and non-sensitizing. | Same |
| Sensitization | |||
| Sterilization | Sterile | ||
| Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Sterile | ||
| Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Same |
Different - Weight per square
The weight per square for the proposed disposable surgical gowns is different from the predicate device. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection level 3 requirement as required by PB70. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
8
Different - Size
The size for the proposed disposable surgical gowns is different from the predicate device. The proposed surgical gowns are available in 6 product sizes, including S, M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Water impact
Although the water impact for the proposed disposable surgical gowns is different from the predicate device, the water impact of the proposed device is better than the predicate device. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Material
The material for the proposed disposable surgical gowns is different from the predicated device. However, the biocompatibility test for proposed device was performed and the results showed no adverse effect. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
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 K211422.