Dream Medi Sterile Surgical Gown (SurgicalGownUL)

K242937 · Dae Myung Chemical Co., Ltd. (Vietnam) · FYA · May 5, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K242937
• Device Name: Dream Medi Sterile Surgical Gown (SurgicalGownUL)
• Applicant: Dae Myung Chemical Co., Ltd. (Vietnam)
• Product Code: FYA · General, Plastic Surgery
• Decision Date: May 5, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.

Device Story

Single-use, disposable sterile surgical gown; constructed from SMS (spunbond-meltblown-polypropylene) nonwoven fabric; features raglan sleeves, hook-and-loop neck closure, and tie waist. Provides AAMI Level 3 liquid barrier protection. Used by operating room personnel during surgical procedures to prevent cross-contamination of microorganisms, body fluids, and particulates between patient and staff. Device is provided sterile via ethylene oxide.

Clinical Evidence

No clinical data. Bench testing only, including AATCC 42 (impact penetration), AATCC 127 (hydrostatic resistance), ASTM D5034 (tensile strength), ASTM D5587 (tear resistance), ASTM D1683 (seam strength), ISO 9073-10 (lint generation), 16 CFR Part 1610 (flammability), and ISO 10993 series (cytotoxicity, irritation, sensitization).

Technological Characteristics

Material: SMS (spunbond-meltblown-polypropylene) nonwoven fabric. Barrier Level: AAMI Level 3. Sterilization: Ethylene Oxide (ISO 11135:2014). Standards: AATCC 42, AATCC 127, ASTM D5034, ASTM D5587, ASTM D1683, ISO 9073-10, 16 CFR 1610, ISO 10993-5/10/23.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to provide AAMI Level 3 barrier protection against microorganisms, body fluids, and particulate matter.

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

• Hubei Woozon Healthcare Co., Ltd. (K222999)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 5, 2025

Dae Myung Chemical Co., Ltd. (vietnam)
Tri Do Minh
QA Manager
Lot CI.II-7a and Lot CI.II-7a', Street No. 5,
Long Thanh Industrial Zone, Tam An Ward
Long Thanh, Dong Nai 810000
Vietnam

Re: K242937
Trade/Device Name: Dream Medi Sterile Surgical Gown (SurgicalGownUL)
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FYA
Dated: June 14, 2024
Received: March 31, 2025

Dear Tri Do Minh:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242937 - Tri Do Minh
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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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K242937 - Tri Do Minh
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assistance/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 Qian -S

Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242937 | |
| Device Name Dream Medi Sterile Surgical Gown (SurgicalGownUL) | |
| Indications for Use (Describe) The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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 [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) Summary
K242937

# 510(k) Summary K242937

(As required by 21 CFR 807.92)

## 1.0 Submitter's information

Name: DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)

Address: Lot CI.II-7a and Lot CI.II-7a', Street No. 5, Long Thanh Industrial Zone, Tam An Ward, Long Thanh Dong Nai 810000 Vietnam

Contac: Mr. Tri Do Minh

Phone Number: [phone]

Email: [e-mail]

Date of Preparation: April 04, 2025

## 2.0 Device information

Trade name: Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Common name: Surgical Gown

Classification name: Gown, Surgical

Model: SurgicalGownUL

Size: S, M, L, XL, XXL

## 3.0 Classification

Production code: FYA - Gown, Surgical

Regulation number: 21CFR 878.4040 - Surgical apparel

Classification: Class II

Panel: Surgical apparel

## 4.0 Predicate device information

Name: Hubei Woozon Healthcare Co., Ltd.

Address: Nongfeng Road, Nonwoven Fabric Industrial Park, Wangzhou Avenue, Pengchang Town, Xiantao City, Hubei, China

K number: K222999

## 5.0 Intended Use/Indication for Use Statement

The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.

In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.

## 6.0 Device description

Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection.

The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL).

SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene.

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510(k) Summary
K242937

The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.

7.0 Technological Characteristic Comparison Table
Table - General Comparison

| Feature | Dream Medi Sterile Surgical Gown | Predicate (K222999) | Comparison |
| --- | --- | --- | --- |
| Regulatory Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Product Code | FYA | FYA | Same |
| Device Name | Surgical Gown | Surgical Gown | Same |
| Models | S, M, L, XL, XXL | S, M, L, XL, XXL | Same |
| Intended Use | Dream Medi Sterile Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). Dream Medi Sterile Surgical Gown are single use, disposable medical devices; the Surgical Gowns were sterilized by EO sterilization based on ISO 11135:2014 | Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided non-sterile. Before the use, the Surgical Gowns must be sterilized by EO sterilization based on ISO 11135:2014. | Same |
| Material | SMS Nonwoven Fabric | SMS Nonwoven Fabric | Same |
| Color | Blue | Blue | Same |
| Sterility | Sterile (by EO sterilization) | Sterile (by EO sterilization) | Same |
| Single Use | Yes | Yes | Same |
| AAMI Barrier Level | Level 3 | Level 3 | Same |
| Impact Penetration (AATCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Hydrostatic Resistance (AATCC) | ≥50 cm | ≥50 cm | Similar |

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510(k) Summary
K242937

| 127) | | | |
| --- | --- | --- | --- |
| Tensile Strength (ASTM D5034) | Machine Direction Wet: 115.44 N (25.9 lbf)
Machine Direction Dry: 114.62 N (25.7 lbf) | Machine Direction Mean: 32.9 lbf
Cross Direction Mean: 26.3 lbf
Cross Direction Wet: 88.5 N (19.89 lbf)
Cross Direction Dry: 94.66 N (21.28 lbf) | Similar |
| Tear Resistance (ASTM D5587) | Machine Direction Mean: 22.59 N
Cross Direction Mean: 15.14 N | Machine Direction Mean: 9.3 lbf
Cross Direction Mean: 18.2 lbf | Similar |
| Seam Strength (ASTM D1683) | Mean 67.17 N | Shoulder: 48.7N
Armhole: 33.9N
Sleeve: 49.6N | Similar |
| Flammability (16 CFR Part 1610) | Ignited but self-extinguished (Class 1) | Class 1, Non Flammable | Same |
| Lint Generation (ISO 9073-10) | Log10 < 4 | Log10 < 4 | Same |
| Cytotoxicity | No potential cytotoxicity | No potential cytotoxicity | Same |
| Irritation | No irritation | No irritation | Same |
| Sensitization | No sensitization | No sensitization | Same |
| Acute Systemic Toxicity | Not performed | No acute systemic toxicity in vivo | Different(A cute Systemic toxicity not required if Cytotoxicity passed.) |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Similar |
| Shelf life | 03 years | 03 years | Same |

## 8.0 Summary of Non-Clinical Testing

Non-clinical testing was performed to confirm that the proposed device met all design specifications. The performance of the subject surgical gown was evaluated using established standards and test methods in accordance with FDA-recognized consensus standards and applicable guidance documents to ensure compliance with safety and performance requirements.

The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints

| Purpose | Test | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Impact Penetration | AATCC 42 | Level 3, ≤1.0 g | Pass |

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510(k) Summary
K242937

| Hydrostatic Resistance | AATCC 127 | Level 3, ≥50 cm | Pass |
| --- | --- | --- | --- |
| Tensile strength | ASTM D5034 | ≥30 N (≥ 7 lbf) | Pass |
| Tear resistance | ASTM D5587 | ≥10 N (≥ 2.3 lbf) | Pass |
| Seam strength | ASTM D1683 | ≥30 N (≥ 7 lbf) | Pass |
| Lint and Other particles generation in the dry state | ISO 9073-10 | Log 10 < 4 | Pass |
| Flammability testing | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Biocompatibility irritation | ISO 10993-23 | Non-irritant | Pass |
| Biocompatibility Sensitization | ISO 10993-10 | Non-sensitizing | Pass |

## 9.0 Summary of Clinical Testing

No clinical study was conducted.

## 10.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device, the Dream Medi Sterile Surgical Gown, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K222999.