(392 days)
Not Found
Not Found
No
The 510(k) summary describes a chemotherapy gown, a physical barrier device, and focuses on its material properties and testing against chemotherapy drugs and liquid barriers. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a protective gown intended for healthcare personnel to prevent exposure to chemotherapy drugs, not to treat a condition or disease in a patient.
No
Explanation: The device is a chemotherapy gown, which is a protective apparel, not a diagnostic tool. Its purpose is to protect healthcare personnel, not to diagnose medical conditions.
No
The device description clearly indicates a physical garment (gown) intended for barrier protection, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The provided text clearly states that the Plus Medical Chemotherapy Gowns are intended to "protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration." This describes a protective barrier worn by individuals, not a device used to analyze biological samples.
- Intended Use: The intended use is focused on personal protection from hazardous substances, not on diagnosing or monitoring a medical condition through the analysis of in vitro samples.
The device is a piece of personal protective equipment (PPE) designed for safety in a healthcare setting.
N/A
Intended Use / Indications for Use
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
Plus Medical Chemotherapy Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. Testing data is provided per test procedure ASTM F739-12, the following 12 chemotherapy drugs has no breakthrough at the Standardized Breakthrough Rate of 0.1ug/cm2/minute, up to 480 minutes.
Test Chemotherapy Drugs Average Standardized Breakthrough Time Carmustine (BCNU) [3.3mg/ml] >480mins Cisplatin [1.0mg/ml] >480mins Cyclophosphamide (Cytoxan) [20.0mg/ml] >480mins Dacarbazine [10.0mg/ml] >480mins Doxorubicin HCI [2.0mg/ml] >480mins Etoposide [20.0mg/ml] >480mins Fluorouracil [50mg/ml] >480mins Methotrexate [25mg/ml] >480mins Mitomycin C [0.5mg/ml] >480mins Paclitaxel [6.0mg/ml] >480mins Thio Tepa [10mg/ml] >480mins Vincristine Sulfate [1.0mg/ml] >480mins *No permeation was detected at either the minimum detectable permeation or 0.1ug/cm2/minute. When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.
Product codes
FYA, QSO
Device Description
The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
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
healthcare personnel
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)
Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
Plus Medical Chemotherapy Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. Testing data is provided per test procedure ASTM F739-12, the following 12 chemotherapy drugs has no breakthrough at the Standardized Breakthrough Rate of 0.1ug/cm2/minute, up to 480 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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May 4, 2022
Foshan Nanhai Plus Medical CO LTD % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K211036
Trade/Device Name: Plus Medical Chemotherapy Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA, QSO Dated: April 1, 2022 Received: April 7, 2022
Dear Olivia Meng:
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 Oian, M.D., Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K211036
Device Name Plus Medical Chemotherapy Gown
Indications for Use (Describe)
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
Plus Medical Chemotherapy Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. Testing data is provided per test procedure ASTM F739-12, the following 12 chemotherapy drugs has no breakthrough at the Standardized Breakthrough Rate of 0.1ug/cm2/minute, up to 480 minutes.
Test Chemotherapy Drugs Average Standardized Breakthrough Time Carmustine (BCNU) [3.3mg/ml] >480mins Cisplatin [1.0mg/ml] >480mins Cyclophosphamide (Cytoxan) [20.0mg/ml] >480mins Dacarbazine [10.0mg/ml] >480mins Doxorubicin HCI [2.0mg/ml] >480mins Etoposide [20.0mg/ml] >480mins Fluorouracil [50mg/ml] >480mins Methotrexate [25mg/ml] >480mins Mitomycin C [0.5mg/ml] >480mins Paclitaxel [6.0mg/ml] >480mins Thio Tepa [10mg/ml] >480mins Vincristine Sulfate [1.0mg/ml] >480mins *No permeation was detected at either the minimum detectable permeation or 0.1ug/cm2/minute. When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.
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.
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