Who is the manufacturer of Copioumed Chemotherapy Isolation Gown?

Copioumed International, Inc. filed the 510(k) submission for Copioumed Chemotherapy Isolation Gown (K230135).

What is the FDA product code for Copioumed Chemotherapy Isolation Gown?

FYC. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Copioumed Chemotherapy Isolation Gown?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Copioumed Chemotherapy Isolation Gown?

AMD Ritmed AssureWear VersaGown (K190306).

Who can help prepare an FDA 510(k) submission like Copioumed Chemotherapy Isolation Gown?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Copioumed Chemotherapy Isolation Gown

K230135 · Copioumed International, Inc. · FYC · Oct 4, 2023 · General, Plastic Surgery

Device Facts

Record ID	K230135
Device Name	Copioumed Chemotherapy Isolation Gown
Applicant	Copioumed International, Inc.
Product Code	FYC · General, Plastic Surgery
Decision Date	Oct 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Indications for Use

Copioumed Chemotherapy Isolation Gown 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. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown 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). Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration.

Device Story

Disposable isolation gown; provides AAMI Level 3 barrier protection. Constructed from polypropylene laminated with polyethylene; features knit cuffs and three neck closure styles (tie, Velcro, sticker). Used by healthcare personnel in clinical settings during chemotherapy drug preparation, handling, and administration. Protects against transfer of microorganisms, body fluids, and particulates; provides resistance to chemotherapy drug permeation (tested per ASTM F739-20). Device is non-sterile and single-use. Clinical benefit: reduces risk of healthcare worker exposure to hazardous chemotherapy agents and cross-contamination.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including AAMI PB70:2012 liquid barrier performance, ASTM F739-20 chemotherapy drug permeation resistance, tensile/tear strength (ASTM D5034, D5587), flammability (16 CFR 1610), and biocompatibility (ISO 10993-5, -10, -23).

Technological Characteristics

Polypropylene laminated with polyethylene; knit cuffs. AAMI Level 3 barrier protection. Tested per ASTM F739-20 for chemotherapy permeation. Tensile strength (ASTM D5034), tear strength (ASTM D5587), hydrostatic pressure (AATCC 127), impact penetration (AATCC 42). Flammability Class 1 (16 CFR 1610). Biocompatible per ISO 10993. Non-sterile, single-use.

Indications for Use

Indicated for healthcare personnel to protect patients and themselves from microorganisms, body fluids, and particulates. Indicated for protection against chemotherapy drug exposure during preparation, handling, and administration. For single-use, non-sterile, OTC use in healthcare facilities.

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

CoverU Disposable Gown with Tape - Chemo Gown (K210414)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". October 4, 2023 Copioumed International Inc. % Ming-Yie Jan Principle Consultant RusCert Technology Co., Ltd. 8F., No. 187, Lequn 2nd Rd., Zhongshan Dist. Taipei City, 10462 Taiwan Re: K230135 Trade/Device Name: Copioumed Chemotherapy Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC, QSO Dated: August 28, 2023 Received: September 5, 2023 Dear Ming-Yie Jan: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Bifeng Qian -S BiFeng Qian, 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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K230135 Device Name Copioumed Chemotherapy Isolation Gown #### Indications for Use (Describe) Copioumed Chemotherapy Isolation Gown 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. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown 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). Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "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 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [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 *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}------------------------------------------------ # 新萬盟有限公司 ### 510(k) SUMMARY | A. 510(K) NUMBER | K230135 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | B. DATE PREPARED | September 27, 2023 | | C. SUBMITTER | COPIOUMED INTERNATIONAL INC. | | D. CONTACT PERSON | Primary Contact Title: General Manager Name: James Liu Tel: + 886 928 644 966 E-Mail: james.liu@gcv.com.tw Official Correspondent Title: Principal Consultant Name: Ming-Yie Jan Tel: + 8886 2 8785 8989 E-Mail: mingyie.jan@ruscert.net | | E. SUBJECT DEVICE | Proprietary Name: Copioumed Chemotherapy Isolation Gown Product Code: FYC, QSO Classification Names: Gown, Isolation, Surgical; Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs Regulation Number 21 CFR 878.4040 Regulation Name: Surgical Apparel Device Class: Class II Review Panel: General Hospital | | F. INDICATIONS FOR USE | Copioumed Chemotherapy Isolation Gown 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. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown 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). Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact." | {6}------------------------------------------------ # 新萬盟有限公司 | | | 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 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [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 | |--|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | *No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm2/min | | | G. PREDICATE DEVICE | Proprietary Name: AMD Ritmed AssureWear VersaGown Product Code: FYC Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel 510(k) Number: K190306 510(k) Submitter: AMD Medicom Inc. Device Class: Class II Review Panel: General Hospital | | | H. REFERENCE DEVICE | Proprietary Name: CoverU Disposable Gown with Tape - Chemo Gown Product Code: FYC, QSO Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel 510(k) Number: K210414 510(k) Submitter: Medtecs (Taiwan) Corp. Device Class: Class II Review Panel: General Hospital | | | I. DEVICE DESCRIPTION | Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. This device is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gown laminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcro neck closure and Sticker neck closure. | K230135 {7}------------------------------------------------ # 新萬盟有限公司 | Elements of Comparison | Proposed Device: Copioumed Chemotherapy Isolation Gown K230135 | Predicate Device: AMD Ritmed AssureWear VersaGown K190306 | Comparisons | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FYC, QSO | FYC | Same for FYC | | Intended Use/Indications for Use | Copioumed Chemotherapy Isolation Gown 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. Copioumed Chemotherapy Isolation Gown is non- sterile and for single use only. Copioumed Chemotherapy Isolation Gown 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). Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact " | AMD Ritmed Assure Wear™ 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™ VersaGown 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 X-large sizes. Flexneck Models Flexneck Plus Models Tie Models A69964 A69933 A8300 A69965 A69934 A8301 A69966 A69935 A8302 A69967 A69936 A8303 A69968 A69937 A8304 A69969 A69938 A8305 | Same: 1. AAMI Level 3 Isolation Gowns 2. Meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 3. Non- sterile and single use only. Similar¹: 1. Protection description Different¹: 1. Evaluated for resistance to permeation of various chemotherapy | # J. COMPARISON OF CHARACTERISTICS WITH THE PREDICATE DEVICE {8}------------------------------------------------ # 新萬盟有限公司 | | 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 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [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 *No permeation was detected at either the minimum detectable permeation or 0.1 µg/cm2/min | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material Composition | Polypropylene Gown laminated with polyethylene | PP SMS non-woven + PE | Similar2 | | Design Features | Knit cuff in three style(model) Tie neck closure, Velcro neck closure and Sticker neck closure | Thumb loop Elastic cuffs Extended cuff (Thumb loop) Flexneck™ Tie (neck) Straight sleeve Inclined sleeve Blue belt tie | Similar3 | | Sterility | Non-sterile | Non-sterile | Same | | Color | Blue | Blue | Same | | Use | OTC | OTC | Same | | Contact Durations | Surface, < 24 hours | Surface, < 24 hours | Same | | Disposable | Disposable | Disposable | Same | | Single Use/Reusable | Single Use | Single Use | Same | | Performance per AAMI PB70:2012 | AAMI Level 3 | AAMI Level 3 | Same | | Basis weight ASTM D3776 | 51.2 ± 1.2 g/m² (1.5 oz/yd² ± 0.04) | 39.97 ± 1.61 g/m² (1.17 oz/yd² ± 0.05) | Similar5 | | Liquid barrier performance: Hydrostatic Pressure AATCC 127 | Pass. Met the standard's requirement (≥ 50 cm H2 O) Testing targets: main body fabric, sleeve seam, shoulder seam, belt, armpit | Chest: 109.34 ± 0.34 cmH2O Sleeve seams: 110.67± 3.84 cmH2O Belt attachments: 104 ± 5.19 cmH2O Body/sleeve/belt mean: 108 ± 3.1 cm H2O | Similar6 | | Liquid barrier performance: Impact Penetration AATCC 42 | Pass, Met the standard's requirement. (≤ 1.0 g) | Chest: <0.1 g Sleeve seams: <0.1 g Belt attachments: < 0.1 g Body/sleeve/belt mean: <0.1 g | Same | | Breaking strength (MD) ASTM D5034 | 15.8 ± 3.7 lbf…

Copioumed Chemotherapy Isolation Gown

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Copioumed Chemotherapy Isolation Gown

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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