(617 days)
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
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.
The provided document is a 510(k) premarket notification for a medical device, specifically a disposable gown. The acceptance criteria and the proof of meeting those criteria are detailed in the non-clinical performance testing section.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| 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 | To determine the Water impact of the test sample. | ATCC 42/AAMI Standard PB70 Level 4 | <1.0 g | Pass |
| Resistance of Materials to Penetration by Viral | To measure blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. | ASTM F1671/F1671M-13/ANSI/AAMI Standard PB70 Level 4 | Penetration Does Not Appear | Pass |
| Basic Weight | To determine the Basic weight of the test article. | ASTM D3776 / D3776M (2020) | Avg. 40 g/m2 ±5% | Pass |
| Grab Tensile Strength | To evaluate the breaking strength of the test sample by test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). | ASTM D5034-09(2017) /ASTM D5034-09(2017) | Tensile strength >=7 lbf (>=30N) | Pass |
| Seam Strength | To evaluate the seam strength of the test sample by the method of Failure in Sewn Seams of Woven Fabrics. | ASTM D1683 / D1683M - 17(2018) | Seam Strength in critical zone >=7 lbf (>=30N) | Pass |
| 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 | To evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | 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 <=4.0 | Pass |
| Resistance to permeation of chemotherapy drugs test | To measure the absorbance of test chemicals, which permeated through the specimens into the collection medium. | ASTM F739-12 | Results showed no average standardized breakthrough for up to 480 minutes for claimed 15 drugs | Pass |
| Cytotoxicity | To evaluate the cytotoxicity of the test sample. | ISO10993-5 | The averaged result concluded that the "Disposable Isolation Gown" extract did not induce cytotoxic to L929 cells. | Pass |
| Irritation | To evaluate the irritation of the test sample. | ISO10993-10 | No erythema and no edema were observed on the skin of the rabbits. Furthermore, the PII values were 0. | Pass |
| Sensitization | To evaluate the sensitization of the test sample. | ISO10993-10 | The submitted sample under the conditions of this study, the test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical performance testing of the device itself (materials, barrier properties, etc.). It does not refer to a "test set" in the context of clinical data or AI model evaluation. The tests performed are laboratory-based and measure physical and chemical properties of the gown.
- Sample size: The document does not explicitly state the number of individual gown samples or material specimens tested for each criterion. It mentions "Avg. 40 g/m2 ±5%" for Basic Weight, which implies an average was taken from multiple measurements, but the N is not provided. For biocompatibility tests (cytotoxicity, irritation, sensitization), typical sample sizes are small (e.g., a few rabbits or cell culture replicates), but they are not specified here.
- Data provenance: The testing was non-clinical (laboratory-based). The applicant company is MEDTECS (TAIWAN) CORP., suggesting the testing may have been conducted there or by a contracted lab. The document does not specify the country of origin of the testing data, nor does it refer to retrospective or prospective data as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The product is a physical medical device (gowns), not an AI/software device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests is defined by established international standards (ASTM, AATCC, ISO, ANSI/AAMI, CPSC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth for diagnostic accuracy, often in imaging or pathology. These are not relevant to the physical and chemical performance testing of medical gowns.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The device is a medical gown, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a medical gown, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is based on established national and international consensus standards for barrier protection, material properties, flammability, and biocompatibility of protective apparel (e.g., ANSI/AAMI PB70:2012, ASTM F1671/F1671M-13, ISO 10993 series, etc.). These standards define the test methods and the acceptable performance thresholds.
8. The sample size for the training set
This question is not applicable. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established
This question is not applicable. There is no AI model or "training set" for this device.
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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.
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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
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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."
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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 RoadXinyi 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 Gown2) 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.
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| Items | Subject DeviceThe CoverU Disposable Gown withTape(K210414) | Predicate DeviceAMD Ritmed AssureWearVersaGown(K190306) | ComparisonResult |
|---|---|---|---|
| Submitter | MEDTECS (TAIWAN) CORP. | Yanbian Pacific Textile Co., LTD | N/A |
| DeviceRegulationnumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | 2 | 2 | Same |
| FDA ProductCode | 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 forUse(CoverUDisposableGown withTape AAMILevel 4Isolation Gown) | The CoverU Disposable Gownwith Tape AAMI Level 4 IsolationGown (Model number:IL4036YKTP-L4) is intended toprovide barrier protection andprotect healthcare personnel andpatients from the transfer ofmicroorganisms, body fluids andparticulate material. CoverUDisposable Gown with Tape meetsthe requirements of AAMI Level 4barrier protection for a surgicalisolation gown per ANSI/ AAMIPB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapesintended for use in health carefacilities. Not intended for use inthe operating room. CoverUDisposable Gown with Tapes is asingle use, disposable medicaldevice provided non-sterile | AMD Ritmed AssureWear™VersaGown is intended to be worn byhealthcare personnel to protect healthcare patients and health carepersonnel from the transfer ofmicroorganisms, body fluids andparticulate material.AssureWear™ VersaGown meets therequirements of an AAMI Level 3barrier protection for an isolationgown per ANSI/AAMI PB70:2012Liquid Barrier PerformanceClassification of Protective ApparelDrapes Intended for Use in HealthCare Facilities (ANSI/AAMI PB70).AMD Ritmed AssureWear™ VersaGown is a single use, non-steriledisposable medical device and notintended for use in operating rooms.The medical device will be availablein 18 models in large and Xlargesizes. | Identical |
| Indications forUse(The CoverUDisposableGown withTape - ChemoGown) | The CoverU Disposable Gownwith Tape - Chemo Gown (Modelnumber IL-4036YKTP-CM) isintended to provide barrierprotection and protect healthcarepersonnel and patients from thetransfer of microorganisms, bodyfluids and particulate material.CoverU Disposable Gown withTape meets the requirements ofAAMI Level 4 barrier protectionfor a surgical isolation gown perANSI/ AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealth care facilities. Not intendedfor use in the operating room.CoverU Disposable Gown withTapes is a single use, disposablemedical device provided non-sterileThe gowns have been evaluatedfor resistance to permeation ofvarious chemotherapy drugs perASTM F739-12, Standard TestMethod for Permeation of Liquidsand Gases Through ProtectiveClothing Materials UnderConditions of Continuous Contact.Chemotherapy drug permeationresistance, average standardizedbreakthrough time in minutes *:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml] >480Doxorubicin Hydrochloride [2mg/ml] > 480Etopside [20 mg/ml] >480Fluorouracil [50 mg/ml] >480Ifosfamide [50 mg/ml] > 480 | No related indication for use of"intended to protect healthcarepersonnel from exposure tochemotherapy drugs" wasclaimed | Different |
| Mitomycin C [0.5 mg/ml] >480Mitoxantrone [2.0 mg/ml] >480Paclitaxel [6 mg/ml] >480Thiotepa [10 mg/ml] >480Vincristine Sulfate [1 mg/ml]>480Docetaxel [10mg/ml] >480Oxaliplatin [5mg/ml] >480Leucovorin [10mg/ml] >480*No permeation was detected ateither the minimum detectablepermeation or 0.1 µg/cm2/minWhen chemotherapy drugs arepresent, gown selection should bebased on the specific type(s) ofchemicals used. Users arerecommended to review druglabeling or material safety datasheets for the chemicals being usedto determine an adequate level ofprotection. | |||
| 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 withnatural rubberlatex | No | No | Same |
| Body fabric | Spunbonded Polypropylenecoated with Polyethylene (PPSBCoated PE materials) | PP SMS non-woven + PE | Different |
| Flammability | CPSC 16 CFR 1610:2010Class 1 | CPSC 16 CFR 1610:2010Class 1 | Identical |
| Thickness ofTextileMaterials | ASTM D1777-96Avg. 0.14mmMeet claimed specification | Not reported in 510kSummary | N/A |
| Basic Weight | ASTM D3776/D3776M-20Between 40 ± 2 g/m2Meet claimed specification | ASTM D3776/D3776M-20Meet claimed specification | Identical |
| Liquid BarrierPerformance | ANSI/AAMI PB70:2012All areas tested meet Level 4performance requirements | ANSI/AAMI PB70:2012All areas tested meet Level 3performance requirements | Different |
| Trapezoid TestTear Strength | ASTM F3352 - 19 /ASTM D5733-99Seam Strength in critical zoneCD >=10N (>=2.3 lbf)MD >=10N (>=2.3 lbf) | ASTM F3352 - 19 /ASTM - D5587Seam Strength in critical zone CD>=10N (>=2.3 lbf)MD >=10N (>=2.3 lbf) | Different |
| IGrab TensileStrength | ASTM D5034-17Breaking strengthCD>=30N (7 lbf)MD>=30N (7 lbf) | ASTM D5034Breaking strengthCD>=30N (7 lbf)MD>=30N (7 lbf) | Identical |
| Seam Strengthtest | ASTM D1683/D1683M-17(R18)12.0 (9.7/ 14.2 lbf) (>=7 lbf) | Not reported in 510kSummary | N/A |
| HydrostaticPressure | AATCC Test Method 127Hydrostatic Pressure(cm):>50cmH2O | AATCC Test Method 127HydrostaticPressure(cm):>50cmH2O | Identical |
| ImpactPenetration | AATCC Test Method 42Water Impact(g) : ≤1.0 | AATCC Test Method 42Water Impact(g): ≤1.0 | Identical |
| Resistance toLinting ofNonwovenFabrics (Dry) | ISO 9073-10Particulate size range(µm): 3 to 25Coefficient of linting <=4.0 | ISO 9073-10Particulate size range(µm): 1 to 25Coefficient of linting <=4.0 | Identical |
| Resistance toPenetration byBlood-BornePathogens | ANSI/AAMI Standard PB70 Level 4/ ASTM F1671/F1671M-13Penetration Does Not Appear | Not reported in 510kSummary | Different |
| Cytotoxicity,ISO10993-5 | Non-cytotoxic | Non-cytotoxic | Identical |
| Irritation,ISO10993-10 | Non-irritating | Non-irritating | Identical |
| Sensitization,ISO10993-10 | Non-sensitizing | Non-sensitizing | Identical |
| Items | Subject DeviceThe CoverU Disposable Gown withTape Chemo Gown, Modelnumber: IL-4036YKTP-CM(K210414) | Reference DeviceCardinal Health ChemoPlusFull Coverage Gown, ClosedBack, Non-sterile(K193327) | ComparisonResult |
| Submitter | MEDTECS (TAIWAN) CORP. | Cardinal Health 200, LLC | N/A |
| DeviceRegulationnumber | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | 2 | 2 | Same |
| FDA ProductCode | FYC, QSO | FYA | Different |
| Indications forUse | The CoverU Disposable Gownwith Tape - Chemo Gown (Modelnumber IL-4036YKTP-CM) isintended to provide barrierprotection and protect healthcarepersonnel and patients from thetransfer of microorganisms, bodyfluids and particulate material.CoverU Disposable Gown withTape meets the requirements ofAAMI Level 4 barrier protectionfor a surgical isolation gown perANSI/ AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealth care facilities. Not intendedfor use in the operating room.CoverU Disposable Gown withTapes is a single use, disposablemedical device provided non-sterile:The gowns have been evaluated forresistance to permeation of variouschemotherapy drugs per ASTMF739-12, Standard Test Method forPermeation of Liquids and GasesThrough ProtectiveClothing Materials UnderConditions of Continuous Contact.Chemotherapy drug permeationresistance, average standardizedbreakthrough time in minutes *:Carmustine [3.3 mg/ml] >480Cisplatin [1.0 mg/ml] >480Cyclophosphamide [20 mg/ml]>480Cytarabine Hydrochloride [100mg/ml] >480Dacarbazine [10 mg/ml] >480Daunorubicin Hydrochloride [5mg/ml] >480Doxorubicin Hydrochloride [2mg/ml] > 480Etopside [20 mg/ml] >480Fluorouracil [50 mg/ml] >480lfosfamide [50 mg/ml] > 480 | The Cardinal Health™ChemoPlus™ Full CoverageGowns, Closed Back, areintended to protect healthcarepersonnel from exposure tochemotherapy drugs duringpreparation, handling, andadministration. The closed backgowns are single use, disposablemedical devices. The non-sterile,closed back gowns are notintended for use in the operatingroom.The proposed gowns meet thebarrier protectionrequirements of AAMI Level3 per ANSI/AAMI StandardPB70:2012 Liquid BarrierPerformance andClassification of ProtectiveApparel and Drapes intendedfor use in Health CareFacilities. The gowns havebeen evaluated for resistanceto permeation of variouschemotherapy drugs perASTM F739-12, StandardTest Method for Permeationof Liquids and Gases ThroughProtective Clothing MaterialsUnder Conditions ofContinuous Contact.Chemotherapy drugpermeation resistance, averagestandardized breakthroughtime in minutes *:Carmustine [3.3 mg/ml]>480 Cisplatin [1.0 mg/ml]>480 Cyclophosphamide [20mg/ml] >480 CytarabineHydrochloride [100 mg/ml]>480 Dacarbazine [10 mg/ml]>480 DaunorubicinHydrochloride [5 mg/ml]>480 DoxorubicinHydrochloride [2 mg/ml] >480 Etopside [20 mg/ml]>480 Fluorouracil [50 mg/ml]>480 lfosfamide [50 mg/ml] > | Similar |
| Fluorouracil [50 mg/ml] >480lfosfamide [50 mg/ml] > 480 | >480 Fluorouracil [50 mg/ml]>480 lfosfamide [50 mg/ml] > | ||
| Methotrexate [25 mg/ml] >480 |
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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.
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| Mitomycin C [0.5 mg/ml] >480Mitoxantrone [2.0 mg/ml] >480Paclitaxel [6 mg/ml] >480Thiotepa [10 mg/ml] >480Vincristine Sulfate [1 mg/ml] >480Docetaxel [10mg/ml] >480Oxaliplatin [5mg/ml] >480Leucovorin [10mg/ml] >480*No permeation was detected ateither the minimum detectablepermeation or 0.1 $µ$ g/cm2/minWhen chemotherapy drugs arepresent, gown selection should bebased on the specific type(s) ofchemicals used. Users arerecommended to review druglabeling or material safety datasheets for the chemicals being usedto determine an adequate level ofprotection. | 480 Methotrexate [25 mg/ml]>480 Mitomycin C [0.5mg/ml] >480 Mitoxantrone[2.0 mg/ml] >480Paclitaxel [6 mg/ml] >480Thiotepa [10 mg/ml] >480Vincristine Sulfate [1 mg/ml] >480*No permeation wasdetected at either the minimumdetectable permeation or 0.1$µ$ g/cm2/min Whenchemotherapy drugs arepresent, gown selection shouldbe based on the specifictype(s) of chemicals used.Users are recommended toreview drug labeling ormaterial safety data sheets forthe chemicals being used todetermine an adequate level ofprotection. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescriptionfor use | No | No | Same |
|---|---|---|---|
| AAMI Level | AAMI Level 4 | AAMI Level 3 | Different |
| Over theCounter | Yes | Yes | Same |
| Drugclaimedfor 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 |
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| Summary of Non-Clinical Performance Testing | ||||
|---|---|---|---|---|
| Resistance topermeation ofchemotherapydrugs test | ASTM F739-12Results showed no averagestandardized breakthrough for up to480 minutes for claimed 15 drugs | ASTM F739-12Results showed no averagestandardized breakthrough for upto 480 minutes for claimed 12drugs | 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.
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- 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 | Testresult |
|---|---|---|---|---|
| Hydrostaticpressure | To determinethehydrostaticpressure ofthe testsample. | ATCC 127/AAMIStandard PB70 Level4 | >50 cm H2O | Pass |
| Water impact | The test wasperformed todetermine theWater impactof the testsample. | ATCC 42/AAMIStandard PB70 Level4 | <1.0 g | Pass |
| Resistance ofMaterials toPenetration byViral | T0 measureblood-bornepathogensusing asurrogatemicrobe underconditions ofcontinuousliquid contact. | ASTMF1671/F1671M-13/ANSI/AAMIStandard PB70 Level4 | Penetration Does Not Appear | Pass |
| Basic weight | To determinethe Basicweight of thetest article. | ASTM D3776 /D3776M (2020) | Avg. 40 g/m2 ±5% | Pass |
| Grab TensileStrength | To evaluatethe breakingstrength of thetest sample bytest Methodfor BreakingStrength andElongation ofTextileFabrics (GrabTest) | ASTM D5034-09(2017) /ASTMD5034-09(2017) | Tensile strength >=7 lbf(>=30N) | Pass |
| Seam Strength | To evaluatethe seam | ASTM D1683 /D1683M - 17(2018) | Seam Strength in critical zone>=7 lbf(>=30N) | Pass |
| Test Performed | Purpose | Test method/Standard followed | Acceptance Criteria | Testresult |
| strength of thetest sample bythe method ofFailure inSewn Seamsof WovenFabrics | ||||
| Trapezoid TestTear Strength | To evaluatethe tearingstrength of thetest sample | ASTM D5733-99/ASTM D5733-99 | Seam Strength in critical zone>=10N (>=2.3 lbf) | Pass |
| Flammability | The test wasperformed inaccordancewith 16 CFRPart 1610Standard fortheFlammabilityof ClothingTextiles toevaluate theflammabilityof the testsample. | 16 CFR Part1610/ASTM F2407-06(2013) e1, Section6.3 flame spread | Class 1 does not Ignite | Pass |
| Resistance toLinting ofNonwovenFabrics (Dry) | To evaluatethe linting ofthe testsample by themethod ofNonwovens-Pat 10: Lintand OtherParticlesGeneration inthe Dry State | EN ISO 9073-10:2004/EN 13795-1:2019 | Requirement Coefficient oflinting <=4.0 | Pass |
| Resistance topermeation ofchemotherapydrugs test | To measuretheabsorbance oftestchemicals,whichpermeatedthrough thespecimensinto thecollectionmedium | ASTM F739-12 | Results showed no averagestandardized breakthrough forup to 480 minutes for claimed15 drugs | Pass |
| Test Performed | Purpose | Test method/Standard followed | Acceptance Criteria | Testresult |
| Cytotoxicity | To evaluatethecytotoxicityof the testsample. | ISO10993-5 | the averaged result whichconcluded that the "DisposableIsolation Gown" extract didnot induce cytotoxic to L929cells. | Pass |
| Irritation | To evaluatethe irritationof the testsample. | ISO10993-10 | No erythema and no edemawere observed on the skin ofthe rabbits. Furthermore, thePII values were 0. | Pass |
| Sensitization | To evaluatethesensitizationof the testsample. | ISO10993-10 | The submitted sample underthe conditions of this study,the test article extract showedno evidence of causingdelayed dermal contactsensitization in the guinea pig. | Pass |
Test Summary Table
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Summary of Clinical Testing:
Clinical testing is not needed for the subject devices.
Conclusions:
The conclusion drawn from the non-clinical tests demonstrates that the subject device, the CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown and CoverU Disposable Gown with Tape - Chemo Gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K190306.
§ 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.