CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

K210414 · Medtecs (Taiwan) Corp. · FYC · Oct 21, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K210414
• Device Name: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
• Applicant: Medtecs (Taiwan) Corp.
• Product Code: FYC · General, Plastic Surgery
• Decision Date: Oct 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

Disposable isolation gown; provides AAMI Level 4 barrier protection against microorganisms, body fluids, and particulates. Constructed from spunbonded polypropylene coated with polyethylene (PPSB Coated PE); features adhesive-taped seams, knit cuffs, and neck/waist ties. Chemo Gown variant tested for permeation resistance against 15 chemotherapy drugs per ASTM F739-12. Used in healthcare facilities by personnel to prevent cross-contamination or exposure to hazardous drugs. Single-use; non-sterile; universal size. Provides physical barrier; does not contain drugs, biologics, or natural rubber latex.

Clinical Evidence

No clinical data; bench testing only. Performance verified via AATCC 42 (impact penetration), AATCC 127 (hydrostatic pressure), ASTM F1671 (viral penetration), ASTM D3776 (weight), ASTM D5034 (tensile strength), ASTM D5733 (tear strength), ASTM D1683 (seam strength), 16 CFR 1610 (flammability), ISO 9073-10 (linting), and ASTM F739-12 (chemo permeation). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Materials: Spunbonded Polypropylene coated with Polyethylene (PPSB Coated PE). Construction: Adhesive-taped seams, knit cuffs, neck/waist ties. Barrier: AAMI Level 4 per ANSI/AAMI PB70:2012. Standards: ASTM D3776 (weight), ASTM D5034 (tensile), ASTM D5733 (tear), ASTM D1683 (seam), ASTM F1671 (viral), ASTM F739 (chemo), CPSC 16 CFR 1610 (flammability), ISO 9073-10 (linting). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile, single-use, universal size.

Indications for Use

Indicated for healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulate material. Chemo Gown model indicated for protection against chemotherapy drug exposure during preparation, handling, and administration. Not for use in operating rooms. Single-use, non-sterile.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AMD Ritmed AssureWear VersaGown (K190306)

Reference Devices

• Cardinal Health ChemoPlus Full Coverage Gown, Closed Back (K193327)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|--|
| <input type="checkbox"/> | |
| <input type="checkbox"/> | |

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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 [e-mail]

"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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# 510(k) Summarv

510(k) Number: K210414

### Applicant Information

| Company Name: | MEDTECS (TAIWAN) CORP. |
|---------------------------|---------------------------------------------------------|
| Company Address: | 11F., No. 9, Songgao Road<br>Xinyi Dist., 11073, Taiwan |
| Telephone: | [phone] |
| Fax: | [phone] |
| 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,<br>North Distrit, Tainan City, 70447 Taiwan |
| Telephone: | [phone] |
| Email: | [e-mail] |
| Contact Person: | Sandy Liu, Consultant |

## Device Name:

| Trade Name: | 1) CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown<br>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

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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 Device<br>The CoverU Disposable Gown with<br>Tape<br>(K210414) | Predicate Device<br>AMD Ritmed AssureWear<br>VersaGown<br>(K190306) | Comparison<br>Result |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Submitter | MEDTECS (TAIWAN) CORP. | Yanbian Pacific Textile Co., LTD | N/A |
| Device<br>Regulation<br>number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | 2 | 2 | Same |
| FDA Product<br>Code | FYC | FYC | Same |
| Sub-model | AAMI Level 4 Isolation Gown<br>(Model number: IL-4036YKTP-L4)<br>and Chemo Gown (Model number IL-<br>4036YKTP-CM) | No information on 510(k)<br>summary | N/A |
| Indications for<br>Use<br>(CoverU<br>Disposable<br>Gown with<br>Tape AAMI<br>Level 4<br>Isolation Gown) | The CoverU Disposable Gown<br>with Tape AAMI Level 4 Isolation<br>Gown (Model number:<br>IL4036YKTP-L4) is intended to<br>provide barrier protection and<br>protect healthcare personnel and<br>patients from the transfer of<br>microorganisms, body fluids and<br>particulate material. CoverU<br>Disposable Gown with Tape meets<br>the requirements of AAMI Level 4<br>barrier protection for a surgical<br>isolation gown per ANSI/ AAMI<br>PB70:2012 Liquid barrier<br>performance and classification of<br>protective apparel and drapes<br>intended for use in health care<br>facilities. Not intended for use in<br>the operating room. CoverU<br>Disposable Gown with Tapes is a<br>single use, disposable medical<br>device provided non-sterile | AMD Ritmed AssureWear™<br>VersaGown is intended to be worn by<br>healthcare personnel to protect health<br>care patients and health care<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material.<br>AssureWear™ VersaGown meets the<br>requirements of an AAMI Level 3<br>barrier protection for an isolation<br>gown per ANSI/AAMI PB70:2012<br>Liquid Barrier Performance<br>Classification of Protective Apparel<br>Drapes Intended for Use in Health<br>Care Facilities (ANSI/AAMI PB70).<br>AMD Ritmed AssureWear™ Versa<br>Gown is a single use, non-sterile<br>disposable medical device and not<br>intended for use in operating rooms.<br>The medical device will be available<br>in 18 models in large and Xlarge<br>sizes. | Identical |
| Indications for<br>Use<br>(The CoverU<br>Disposable<br>Gown with<br>Tape - Chemo<br>Gown) | The CoverU Disposable Gown<br>with Tape - Chemo Gown (Model<br>number IL-4036YKTP-CM) is<br>intended to provide barrier<br>protection and protect healthcare<br>personnel and patients from the<br>transfer of microorganisms, body<br>fluids and particulate material.<br>CoverU Disposable Gown with<br>Tape meets the requirements of<br>AAMI Level 4 barrier protection<br>for a surgical isolation gown per<br>ANSI/ AAMI PB70:2012 Liquid<br>barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities. Not intended<br>for use in the operating room.<br>CoverU Disposable Gown with<br>Tapes is a single use, disposable<br>medical device provided non-<br>sterile<br>The gowns have been evaluated<br>for resistance to permeation of<br>various chemotherapy drugs per<br>ASTM F739-12, Standard Test<br>Method for Permeation of Liquids<br>and Gases Through Protective<br>Clothing Materials Under<br>Conditions of Continuous Contact.<br>Chemotherapy drug permeation<br>resistance, average standardized<br>breakthrough time in minutes *:<br>Carmustine [3.3 mg/ml] >480<br>Cisplatin [1.0 mg/ml] >480<br>Cyclophosphamide [20 mg/ml]<br>>480<br>Cytarabine Hydrochloride [100<br>mg/ml] >480<br>Dacarbazine [10 mg/ml] >480<br>Daunorubicin Hydrochloride [5<br>mg/ml] >480<br>Doxorubicin Hydrochloride [2<br>mg/ml] > 480<br>Etopside [20 mg/ml] >480<br>Fluorouracil [50 mg/ml] >480<br>Ifosfamide [50 mg/ml] > 480 | No related indication for use of<br>"intended to protect healthcare<br>personnel from exposure to<br>chemotherapy drugs" was<br>claimed | Different |
| | Mitomycin C [0.5 mg/ml] >480<br>Mitoxantrone [2.0 mg/ml] >480<br>Paclitaxel [6 mg/ml] >480<br>Thiotepa [10 mg/ml] >480<br>Vincristine Sulfate [1 mg/ml]<br>>480<br>Docetaxel [10mg/ml] >480<br>Oxaliplatin [5mg/ml] >480<br>Leucovorin [10mg/ml] >480<br>*No permeation was detected at<br>either the minimum detectable<br>permeation or 0.1 µg/cm2/min<br>When chemotherapy drugs are<br>present, gown selection should be<br>based on the specific type(s) of<br>chemicals used. Users are<br>recommended to review drug<br>labeling or material safety data<br>sheets for the chemicals being used<br>to determine an adequate level of<br>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<br>natural rubber<br>latex | No | No | Same |
| Body fabric | Spunbonded Polypropylene<br>coated with Polyethylene (PPSB<br>Coated PE materials) | PP SMS non-woven + PE | Different |
| Flammability | CPSC 16 CFR 1610:2010<br>Class 1 | CPSC 16 CFR 1610:2010<br>Class 1 | Identical |
| Thickness of<br>Textile<br>Materials | ASTM D1777-96<br>Avg. 0.14mm<br>Meet claimed specification | Not reported in 510k<br>Summary | N/A |
| Basic Weight | ASTM D3776/D3776M-20<br>Between 40 ± 2 g/m2<br>Meet claimed specification | ASTM D3776/D3776M-20<br>Meet claimed specification | Identical |
| Liquid Barrier<br>Performance | ANSI/AAMI PB70:2012<br>All areas tested meet Level 4<br>performance requirements | ANSI/AAMI PB70:2012<br>All areas tested meet Level 3<br>performance requirements | Different |
| Trapezoid Test<br>Tear Strength | ASTM F3352 - 19 /ASTM D5733-99<br>Seam Strength in critical zone<br>CD >=10N (>=2.3 lbf)<br>MD >=10N (>=2.3 lbf)…