(393 days)
Not Found
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 surgical gown intended for barrier protection, not for treating or preventing a disease or condition in a patient.
No
The device is a surgical gown, which is a protective barrier, not an instrument for diagnosing medical conditions.
No
The device is a physical surgical gown made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gown is for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties of the gown (material, layers, barrier level). There is no mention of any components or functions related to testing or analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical gown does not perform any such function.
The device is a medical device intended for barrier protection during surgical procedures.
N/A
Intended Use / Indications for Use
The Disposable Ultra Reinforced Surgical Gown is 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. In addition, 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. It is single use, disposable medical devices, provided sterile
Product codes
FYA
Device Description
The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
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 / health care facilities
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. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:
- 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 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ASTM F2407-06, Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities.
- CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles:
- AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
- 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 Apparel > and Drapes Intended For Use In Health Care Facilities.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). The logo consists of two parts: the Department of Health & 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.
January 16, 2019
Xiantao Rayxin Medical Products Co., Ltd. Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, 102401 Cn
Re: K173847
Trade/Device Name: Disposable Ultra Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 4, 2018 Received: December 7, 2018
Dear Ray 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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) K173847
Device Name
Disposable Ultra Reinforced Surgical Gown
Indications for Use (Describe)
The Disposable Ultra Reinforced Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile
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 Title 21 CFR Section 807.92.
The assigned 510(k) Number: K173847
-
- Date of Preparation:2019/01/16
-
- Sponsor Identification
Xiantao Rayxin Medical Products Co., Itd. No. 258 Pengchang Road, Middle Street, Xiantao city, Hubei 433018, China
Contact Person: Liang Zhang Position: General Manager Tel: +86-728-2617592 Fax: +86-728-2617777 Email: zl@rayxin.com
- Designated Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd
Email: Ray.Wang(@believe-med.com
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4. Identification of Predicate Device(s)
Predicate Device K170762 Cardinal Health Surgical Gown Cardinal Health 200, LLC
ર . Identification of Proposed Device
Trade Name: Disposable Ultra Reinforced Surgical Gown Common Name: Surgical Gown Model(s): S. M., L., XL
Regulatory Information Classification Name: Surgical Gown Classification: 2 Product Code: FYA Regulation Number: 878.4040 Review Panel: General & Plastic Surgery
Device Description
The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The subject devices 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 materials.
In addition, 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.
The proposed devices are single use, disposable medical devices and provided sterile.
Indication for use Statement:
The Disposable Ultra Reinforced Surgical Gown is 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. In addition, 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. It is single use, disposable medical devices, provided sterile
5
Technological Characteristic Comparison Table 6.
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Intended Use | Disposable Ultra Reinforced Surgical Gown is 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. In addition, 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. It is single use, disposable | ||||
| medical devices, provided sterile | Cardinal Health™ Non-Reinforced Surgical Gown is 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. In addition, 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 Cardinal Health™ | ||||
| Non-Reinforced Surgical Gowns are single use, disposable medical devices; | ||||
| provided sterile and non-sterile. | SAME | |||
| Material | SMS polypropylene nonwoven | SMS polypropylene nonwoven | SAME | |
| Use | Single Use; Disposable | Single Use; Disposable | SAME | |
| Sterility | Sterile | Sterile and non-sterile | SAME | |
| Color | Blue | Blue | SAME | |
| Weight per square (g) | $44 g/m^2$ | $31g/ m^2 (1.32 oz/yd^2)$ | Similar | |
| Tensile | MD Mean ≥30 lbs; | |||
| CD Mean≥25 lbs | MD Mean 21.57 lbs | |||
| CD Mean 13.6 lbs | Similar |
6
| Tear | MD Mean ≥9 lbs;
CD Mean≥18 lbs | MD Mean 3.47 lbs
CD Mean 5.63 lbs | Similar |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------|
| Flammability (sec.)
CPSC, Part 1610 | Class I | Class I | SAME |
| Hydrostatic Pressure
(cm)
AATCC-127 | >50 cm | >50 cm | SAME |
| Water Impact (g)
AATCC-42 | ≤1.0 g | ≤1.0 g | SAME |
| Resistance to blood
and liquid penetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | SAME |
| Biocompatibility | Under the conditions of the study, the device extract was not cytotoxic. | | SAME |
| | 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. | | |
| Sterilization Method
& SAL | Ethylene Oxide (EO), SAL=10-6
The EO/ECH residues meet the requirements of ISO 10993-7 | Ethylene Oxide (EO), SAL=10-6
The EO/ECH residues meet the requirements of ISO 10993-7 | SAME |
| Size | S, M, L, XL | M-S, M, L, XL, XXL | SAME |
Analysis: The proposed device has same or better performance to the predicate device. So we consider which is same with the predicate.
7
-
- Summary of Non-Clinical Performance Test
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:
- Summary of Non-Clinical Performance Test
-
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 10993-7: 2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
ASTM F2407-06, Standard Specification For Surgical Gowns Intended For Use In Healthcare Facilities.
-
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles:
-
AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
-
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 Apparel > and Drapes Intended For Use In Health Care Facilities.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K170762.
- Conclusion: