(617 days)
No
The device is a disposable isolation gown and the summary describes its material, construction, and barrier performance testing, with no mention of AI or ML.
No.
The device is an isolation gown intended for barrier protection, not for treating a disease or medical condition.
No
The device is described as an isolation gown intended to provide barrier protection against microorganisms, body fluids, and particulate material, and in one model, resistance to chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical gown constructed of PPSB Coated PE materials with seams sealed by adhesive tape. It is a tangible, disposable medical device.
Based on the provided text, 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.
- Device Description and Intended Use: The description and intended use of the CoverU Disposable Gown clearly state its purpose is to provide barrier protection for healthcare personnel and patients from the transfer of microorganisms, body fluids, particulate material, and chemotherapy drugs. It is a physical barrier worn on the body.
- No mention of testing samples: There is no indication that this gown is used to analyze or test any biological samples.
Therefore, the CoverU Disposable Gown with Tape is a protective medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CoverU Disposable Gown with Tape - AAMI Level 4 Isolation Gown (Model number: IL-4036YKTP-L4) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile.
CoverU Disposable Gown with Tape- Chemo Gown (Model number: IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have 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 Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480
*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min
Product codes (comma separated list FDA assigned to the subject device)
FYC, QSO
Device Description
The CoverU Disposable Gown with Tape is constructed of PPSB Coated PE materials with the color in yellow. It is sealed the seam by Adheresive tape provide protection from liquid borne. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. Tie at the neck and waist for secure protection AAMI level 4 standard provides high performance on hydrostatic pressure and fluids impact.
The CoverU Disposable Gown with Tape is sold in one size, non-sterile and is intended to be a single use, disposable device, and does NOT contain any drugs or biologics and not made with natural rubber latex. The two gown models are exact the same gowns, except the chemo-drug labeling claim. one is intended to protect workers from high fluid level (blood body fluids etc.) and blood borne pathogen, and the other is intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. Ten (10) pieces of CoverU Disposable Gown with Tape are packaged in a plastic bag and ten bags are outer packaging with a paper carton box. These gowns are offered in a universal size.
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; health care facilities. Not intended for use in the 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 testing was performed per Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings. The standards followed include:
- AATCC 42: Test Method for Water Resistance: Impact Penetration.
- AATCC TM127-2017: Test Method for Water Resistance: Hydrostatic Pressure.
- 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 D3776/D3776M (2020), Test Methods for Mass Per Unit Area (Weight) of Woven Fabric.
- ASTM D5034-09(2013), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test).
- ASTM D5733-99, Standard Test Method for Tear Strength of Non Woven Fabrics by Trapezoid Procedure
- ASTM D1683/D1683M-17, Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D1777-96(2019): Standard Test Method for Thickness of Textile Materials
- CPSC 16 Part 1610, Standard for The Flammability of Clothing Textiles.
- ASTM F739 12, Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact
- ISO 10993- 1: 2009/(R)2013, Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process.
- 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 9073-10:2004, Textiles-Test methods for nonwovens-Part 10: Lint and other particles generation in the dry state.
Key results:
- Hydrostatic pressure: >50 cm H2O (Pass)
- Water impact: =7 lbf (>=30N) (Pass)
- Seam Strength: Seam Strength in critical zone >=7 lbf (>=30N) (Pass)
- Trapezoid Test Tear Strength: Seam Strength in critical zone >=10N (>=2.3 lbf) (Pass)
- Flammability: Class 1 does not Ignite (Pass)
- Resistance to Linting of Nonwoven Fabrics (Dry): Requirement Coefficient of linting
§ 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). 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.
October 21, 2022
Medtecs (Taiwan) Corp. % Sandy Liu Consultant Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, 70447 Taiwan
Re: K210414
Trade/Device Name: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC. OSO Dated: September 26, 2022 Received: September 26, 2022
Dear Sandy Liu:
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 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.
Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210414
Device Name
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
Indications for Use (Describe)
CoverU Disposable Gown with Tape - AAMI Level 4 Isolation Gown (Model number: IL-4036YKTP-LA) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-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)
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
Indications for Use
510(k) Number (if known) K210414
Device Name
CoverU Disposable Gown with Tape - Chemo Gown
Indications for Use (Describe)
CoverU Disposable Gown with Tape- Chemo Gown (Model number: IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have 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 Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/m]] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480 *No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min
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.
4
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."
5
510(k) Summarv
510(k) Number: K210414
Applicant Information
| Company Name: | MEDTECS (TAIWAN) CORP. |
|---|---|
| Company Address: | 11F., No. 9, Songgao Road |
| Xinyi Dist., 11073, Taiwan | |
| Telephone: | +886-2-27392222 |
| Fax: | +886-2-27297896 |
| Submitter: | William Yang |
| Summary Preparation Date: | 2022.10.17 |
Official Correspondent
| Company Name: | Jin Services Co. |
|---|---|
| Company Address: | 9F-1, No13, Lane41, Changrong Rd, Sec. 5, |
| North Distrit, Tainan City, 70447 Taiwan | |
| Telephone: | +886-917535026 |
| Email: | contact@fdaclass.com |
| Contact Person: | Sandy Liu, Consultant |
Device Name:
| Trade Name: | 1) CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown
2) CoverU Disposable Gown with Tape - Chemo Gown |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Gown, Isolation, Surgical |
| Regulation Number: | 878.4040 |
| Product Code: | FYC, QSO |
| Device Class: | Class 2 |
| Panel: | General Hospital |
PREDICATE DEVICE:
- K190306, AMD Ritmed AssureWear VersaGown AMD Medicom Inc. ●
REFERENCE DEVICE:
- K 193327, Cardinal Health ChemoPlus Full Coverage Gown, Closed Back Cardinal Health ● 200, LLC,
Device Description
The CoverU Disposable Gown with Tape is constructed of PPSB Coated PE materials with the color in yellow. It is sealed the seam by Adheresive tape provide protection from liquid borne. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. Tie at the neck and waist for secure protection AAMI level 4 standard provides high performance on hydrostatic pressure and fluids impact.
The CoverU Disposable Gown with Tape is sold in one size, non-sterile and is intended to be a single use, disposable device, and does NOT contain any drugs or biologics and not made with natural rubber latex. The two gown models are exact the same gowns, except the chemo-drug labeling claim. one is intended to protect workers from high fluid level (blood body fluids etc.) and blood borne pathogen, and the other is intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. Ten (10) pieces of CoverU Disposable Gown
6
with Tape are packaged in a plastic bag and ten bags are outer packaging with a paper carton box. These gowns are offered in a universal size.
Intended Use/Indications for Use:
The CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown (Model number: IL4036YKTP-L4) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile.
The CoverU Disposable Gown with Tape - Chemo Gown (Model number IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have 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. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480
*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min Technological characteristics Comparison for the proposed and predicate devices The following is a summary of the technological characteristics of the CoverU Disposable Gown with Tape as compared to the predicate device.
7
| Items | Subject Device
The CoverU Disposable Gown with
Tape
(K210414) | Predicate Device
AMD Ritmed AssureWear
VersaGown
(K190306) | Comparison
Result |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Submitter | MEDTECS (TAIWAN) CORP. | Yanbian Pacific Textile Co., LTD | N/A |
| Device
Regulation
number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | 2 | 2 | Same |
| FDA Product
Code | FYC | FYC | Same |
| Sub-model | AAMI Level 4 Isolation Gown
(Model number: IL-4036YKTP-L4)
and Chemo Gown (Model number IL-
4036YKTP-CM) | No information on 510(k)
summary | N/A |
| Indications for
Use
(CoverU
Disposable
Gown with
Tape AAMI
Level 4
Isolation Gown) | The CoverU Disposable Gown
with Tape AAMI Level 4 Isolation
Gown (Model number:
IL4036YKTP-L4) is intended to
provide barrier protection and
protect healthcare personnel and
patients from the transfer of
microorganisms, body fluids and
particulate material. CoverU
Disposable Gown with Tape meets
the requirements of AAMI Level 4
barrier protection for a surgical
isolation gown per ANSI/ AAMI
PB70:2012 Liquid barrier
performance and classification of
protective apparel and drapes
intended for use in health care
facilities. Not intended for use in
the operating room. CoverU
Disposable Gown with Tapes is a
single use, disposable medical
device provided non-sterile | AMD Ritmed AssureWear™
VersaGown is intended to be worn by
healthcare personnel to protect health
care patients and health care
personnel from the transfer of
microorganisms, body fluids and
particulate material.
AssureWear™ VersaGown meets the
requirements of an AAMI Level 3
barrier protection for an isolation
gown per ANSI/AAMI PB70:2012
Liquid Barrier Performance
Classification of Protective Apparel
Drapes Intended for Use in Health
Care Facilities (ANSI/AAMI PB70).
AMD Ritmed AssureWear™ Versa
Gown is a single use, non-sterile
disposable medical device and not
intended for use in operating rooms.
The medical device will be available
in 18 models in large and Xlarge
sizes. | Identical |
| Indications for
Use
(The CoverU
Disposable
Gown with
Tape - Chemo
Gown) | The CoverU Disposable Gown
with Tape - Chemo Gown (Model
number IL-4036YKTP-CM) is
intended to provide barrier
protection and protect healthcare
personnel and patients from the
transfer of microorganisms, body
fluids and particulate material.
CoverU Disposable Gown with
Tape meets the requirements of
AAMI Level 4 barrier protection
for a surgical isolation gown per
ANSI/ AAMI PB70:2012 Liquid
barrier performance and
classification of protective apparel
and drapes intended for use in
health care facilities. Not intended
for use in the operating room.
CoverU Disposable Gown with
Tapes is a single use, disposable
medical device provided non-
sterile
The gowns have 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.
Chemotherapy drug permeation
resistance, average standardized
breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml]
480
Cytarabine Hydrochloride [100
mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5
mg/ml] >480
Doxorubicin Hydrochloride [2
mg/ml] > 480
Etopside [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
Ifosfamide [50 mg/ml] > 480 | No related indication for use of
"intended to protect healthcare
personnel from exposure to
chemotherapy drugs" was
claimed | Different |
| | Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml]
480
Docetaxel [10mg/ml] >480
Oxaliplatin [5mg/ml] >480
Leucovorin [10mg/ml] >480
*No permeation was detected at
either the minimum detectable
permeation or 0.1 µg/cm2/min
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. | | |
| Color | Yellow | Blue | Different |
| Gown Style | Close-back | Close-back | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| AAMI Level | AAMI Level 4 | AAMI Level 3 | Different |
| Made with
natural rubber
latex | No | No | Same |
| Body fabric | Spunbonded Polypropylene
coated with Polyethylene (PPSB
Coated PE materials) | PP SMS non-woven + PE | Different |
| Flammability | CPSC 16 CFR 1610:2010
Class 1 | CPSC 16 CFR 1610:2010
Class 1 | Identical |
| Thickness of
Textile
Materials | ASTM D1777-96
Avg. 0.14mm
Meet claimed specification | Not reported in 510k
Summary | N/A |
| Basic Weight | ASTM D3776/D3776M-20
Between 40 ± 2 g/m2
Meet claimed specification | ASTM D3776/D3776M-20
Meet claimed specification | Identical |
| Liquid Barrier
Performance | ANSI/AAMI PB70:2012
All areas tested meet Level 4
performance requirements | ANSI/AAMI PB70:2012
All areas tested meet Level 3
performance requirements | Different |
| Trapezoid Test
Tear Strength | ASTM F3352 - 19 /ASTM D5733-99
Seam Strength in critical zone
CD >=10N (>=2.3 lbf)
MD >=10N (>=2.3 lbf) | ASTM F3352 - 19 /ASTM - D5587
Seam Strength in critical zone CD
=10N (>=2.3 lbf)
MD >=10N (>=2.3 lbf) | Different |
| IGrab Tensile
Strength | ASTM D5034-17
Breaking strength
CD>=30N (7 lbf)
MD>=30N (7 lbf) | ASTM D5034
Breaking strength
CD>=30N (7 lbf)
MD>=30N (7 lbf) | Identical |
| Seam Strength
test | ASTM D1683/D1683M-17(R18)
12.0 (9.7/ 14.2 lbf) (>=7 lbf) | Not reported in 510k
Summary | N/A |
| Hydrostatic
Pressure | AATCC Test Method 127
Hydrostatic Pressure(cm):>50cmH2O | AATCC Test Method 127
Hydrostatic
Pressure(cm):>50cmH2O | Identical |
| Impact
Penetration | AATCC Test Method 42
Water Impact(g) : ≤1.0 | AATCC Test Method 42
Water Impact(g): ≤1.0 | Identical |
| Resistance to
Linting of
Nonwoven
Fabrics (Dry) | ISO 9073-10
Particulate size range(µm): 3 to 25
Coefficient of linting 480
Cisplatin [1.0 mg/ml] >480
Cyclophosphamide [20 mg/ml]
480
Cytarabine Hydrochloride [100
mg/ml] >480
Dacarbazine [10 mg/ml] >480
Daunorubicin Hydrochloride [5
mg/ml] >480
Doxorubicin Hydrochloride [2
mg/ml] > 480
Etopside [20 mg/ml] >480
Fluorouracil [50 mg/ml] >480
lfosfamide [50 mg/ml] > 480 | The Cardinal Health™
ChemoPlus™ Full Coverage
Gowns, Closed Back, are
intended to protect healthcare
personnel from exposure to
chemotherapy drugs during
preparation, handling, and
administration. The closed back
gowns are single use, disposable
medical devices. The non-sterile,
closed back gowns are not
intended for use in the operating
room.
The proposed gowns meet the
barrier protection
requirements of AAMI Level
3 per ANSI/AAMI Standard
PB70:2012 Liquid Barrier
Performance and
Classification of Protective
Apparel and Drapes intended
for use in Health Care
Facilities. The gowns have
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.
Chemotherapy drug
permeation resistance, average
standardized breakthrough
time in minutes *:
Carmustine [3.3 mg/ml]
480 Cisplatin [1.0 mg/ml]
480 Cyclophosphamide [20
mg/ml] >480 Cytarabine
Hydrochloride [100 mg/ml]
480 Dacarbazine [10 mg/ml]
480 Daunorubicin
Hydrochloride [5 mg/ml]
480 Doxorubicin
Hydrochloride [2 mg/ml] >
480 Etopside [20 mg/ml]
480 Fluorouracil [50 mg/ml]
480 lfosfamide [50 mg/ml] > | Similar |
| | Fluorouracil [50 mg/ml] >480
lfosfamide [50 mg/ml] > 480 | >480 Fluorouracil [50 mg/ml]
480 lfosfamide [50 mg/ml] > | |
| | Methotrexate [25 mg/ml] >480 | | |
8
9
10
To compare with the legal marketed Chemo gown, another cleared device, Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Non-sterile, was selected for reference. The following is a summary of the technological characteristics of CoverU Disposable Gown with Tape - Chemo Gown, Model number: IL-4036YKTP-CM as compared to the reference device.
11
12
13
| Mitomycin C [0.5 mg/ml] >480
Mitoxantrone [2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480
Docetaxel [10mg/ml] >480
Oxaliplatin [5mg/ml] >480
Leucovorin [10mg/ml] >480
*No permeation was detected at
either the minimum detectable
permeation or 0.1 $µ$ g/cm2/min
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. | 480 Methotrexate [25 mg/ml]
480 Mitomycin C [0.5
mg/ml] >480 Mitoxantrone
[2.0 mg/ml] >480
Paclitaxel [6 mg/ml] >480
Thiotepa [10 mg/ml] >480
Vincristine Sulfate [1 mg/ml] >480
*No permeation was
detected at either the minimum
detectable permeation or 0.1
$µ$ g/cm2/min 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. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription
| for use | No | No | Same |
|---|---|---|---|
| AAMI Level | AAMI Level 4 | AAMI Level 3 | Different |
| Over the | |||
| Counter | Yes | Yes | Same |
| Drug | |||
| claimed | |||
| for protection | 15 drugs | ||
| • Carmustine | |||
| • Cisplatin | |||
| • Cyclophosphamide | |||
| • Cytarabine Hydrochloride | |||
| • Dacarbazine | |||
| • Daunorubicin Hydrochloride | |||
| • Doxorubicin Hydrochloride | |||
| • Etoposide | |||
| • Fluorouracil | |||
| • Ifosfamide | |||
| • Methotrexate | |||
| • Mitomycin C | |||
| • Paclitaxel | |||
| • Thiotepa | |||
| • Vincristine Sulfate | 12 drugs | ||
| • Carmustine | |||
| • Cisplatin | |||
| • Cyclophosphamide | |||
| • Dacarbazine | |||
| • Doxorubicin Hydrochloride | |||
| • Etoposide | |||
| • Fluorouracil | |||
| • Methotrexate | |||
| • Mitomycin C | |||
| • Paclitaxel | |||
| • Thiotepa | |||
| • Vincristine Sulfate | Different |
14
| Summary of Non-Clinical Performance Testing | ||||
|---|---|---|---|---|
| Resistance to | ||||
| permeation of | ||||
| chemotherapy | ||||
| drugs test | ASTM F739-12 | |||
| Results showed no average | ||||
| standardized breakthrough for up to | ||||
| 480 minutes for claimed 15 drugs | ASTM F739-12 | |||
| Results showed no average | ||||
| standardized breakthrough for up | ||||
| to 480 minutes for claimed 12 | ||||
| drugs | Similar |
Discussion
The difference in the designs, materials and colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
Summary of Non-Clinical Testing
Per Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, the following standards and the requirements have been confirmed for CoverU Disposable Gown with Tape:
- AATCC 42: Test Method for Water Resistance: Impact Penetration .
- AATCC TM127-2017: Test Method for Water Resistance: Hydrostatic Pressure .
- . 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 D3776/D3776M (2020), Test Methods for Mass Per Unit Area (Weight) of Woven Fabric. .
- ASTM D5034-09(2013), Standard Test Method for Breaking Strength and Elongation of Textile . Fabrics (Grab Test).
- ASTM D5733-99, Standard Test Method for Tear Strength of Non Woven Fabrics by Trapezoid . Procedure
- . ASTM D1683/D1683M-17, Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D1777-96(2019): Standard Test Method for Thickness of Textile Materials .
- CPSC 16 Part 1610, Standard for The Flammability of Clothing Textiles. .
- ASTM F739 12, Standard Test Method for Permeation of Liquids and Gases through Protective . Clothing Materials under Conditions of Continuous Contact
- . ISO 10993- 1: 2009/(R)2013, Biological Evaluation of Medical Devices- Part 1:
Evaluation and testing within a risk management process.
15
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices Part 5: Tests Forln Vitro . Cytotoxicity.
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And . Skin Sensitization.
- ISO 9073-10:2004, Textiles-Test methods for nonwovens-Part 10: Lint and other particles • generation in the dry state.
| Test Performed | Purpose | Test method/
Standard followed | Acceptance Criteria | Test
result |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Hydrostatic
pressure | To determine
the
hydrostatic
pressure of
the test
sample. | ATCC 127/AAMI
Standard PB70 Level
4 | >50 cm H2O | Pass |
| Water impact | The test was
performed to
determine the
Water impact
of the test
sample. | ATCC 42/AAMI
Standard PB70 Level
4 | =7 lbf
(>=30N) | Pass |
| Seam Strength | To evaluate
the seam | ASTM D1683 /
D1683M - 17(2018) | Seam Strength in critical zone
=7 lbf(>=30N) | Pass |
| Test Performed | Purpose | Test method/
Standard followed | Acceptance Criteria | Test
result |
| | strength of the
test sample by
the method of
Failure in
Sewn Seams
of Woven
Fabrics | | | |
| Trapezoid Test
Tear Strength | To evaluate
the tearing
strength of the
test sample | ASTM D5733-
99/ASTM D5733-99 | Seam Strength in critical zone
=10N (>=2.3 lbf) | Pass |
| 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. | 16 CFR Part
1610/ASTM F2407-
06(2013) e1, Section
6.3 flame spread | Class 1 does not Ignite | Pass |
| Resistance to
Linting of
Nonwoven
Fabrics (Dry) | To evaluate
the linting of
the test
sample by the
method of
Nonwovens-
Pat 10: Lint
and Other
Particles
Generation in
the Dry State | EN ISO 9073-
10:2004/EN 13795-
1:2019 | Requirement Coefficient of
linting