(222 days)
Not Found
No.
The device is a surgical gown, which is a physical product and contains no electronic components or software capable of supporting an AI model.
No.
The Dream Medi Sterile Surgical Gowns are protective apparel designed to prevent the transfer of microorganisms, body fluids, and particulate matter, not to treat or cure a disease or condition.
No
The document describes surgical gowns intended to protect patients and personnel from the transfer of microorganisms and bodily fluids during surgical procedures. This is a protective device, not a device used to diagnose a medical condition.
No
The device is a physical medical device (surgical gowns) and its description clearly outlines its material composition, physical dimensions, and performance characteristics based on physical testing, not software. It has no mention of software components.
No.
This device is a sterile surgical gown, intended for physical barrier protection during surgical procedures. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for 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.
Product codes
FYA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed 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.
Tests performed: Impact Penetration (AATCC 42), Hydrostatic Resistance (AATCC 127), Tensile strength (ASTM D5034), Tear resistance (ASTM D5587), Seam strength (ASTM D1683), Lint and Other particles generation in the dry state (ISO 9073-10), Flammability testing (16 CFR Part 1610), Biocompatibility cytotoxicity (ISO 10993-5), Biocompatibility irritation (ISO 10993-23), Biocompatibility Sensitization (ISO 10993-10). All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
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.
Page 2
K242937 - Tri Do Minh Page 2
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-
Page 3
K242937 - Tri Do Minh Page 3
assistance/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 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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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
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."
Page 5
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
Contact: Mr. Tri Do Minh
Phone Number: +84 251-3514 017
Email: qc.tri@dmpoly.com
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.
Page 6
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 127) | ≥50 cm | ≥50 cm | Similar |
Page 7
| Feature | Dream Medi Sterile Surgical Gown | Predicate (K222999) | Comparison |
|---|---|---|---|
| Tensile Strength (ASTM D5034) | Machine Direction Wet: 115.44 N (25.9 lbf) | ||
| Machine Direction Dry: 114.62 N (25.7 lbf) | |||
| Cross Direction Wet: 88.5 N (19.89 lbf) | |||
| Cross Direction Dry: 94.66 N (21.28 lbf) | Machine Direction Mean: 32.9 lbf | ||
| Cross Direction Mean: 26.3 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 |