(242 days)
Not Found
No
The device is a disposable surgical isolation gown, and the description focuses on material properties and barrier protection levels, with no mention of AI or ML.
No
The device is a Disposable Surgical Isolation Gown, which protects against the transfer of microorganisms, body fluids, and particulate material; it does not provide therapeutic benefits.
No
Explanation: The device is a Disposable Surgical Isolation Gown, intended to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material. It is a protective barrier, not a diagnostic tool used to identify or determine the nature of a disease or condition.
No
The device described is a physical garment (surgical isolation gown) made of fabric, not software. The description focuses on material properties, barrier protection levels, and physical dimensions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "Disposable Surgical Isolation Gown" intended to "protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material." This is a barrier protection device, not a device used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, reagents, or diagnostic testing.
Therefore, this device falls under the category of personal protective equipment (PPE) and is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns 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 Disposable Surgical Isolation Gowns are single use, disposable medical devices: provided non-sterile.
Product codes
FYC
Device Description
Surgical Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is SMS compound non-woven fabric. It is a kind of Non- Reinforced surgical isolation gown. Disposable Surgical Isolation Gowns are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Surgical Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S, M, L, XL, XXL, and XXXL.
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
health care patients and health care personnel / medical environment (Not intended for use in the 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
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards: ISO 10993-5: 2009, ISO 10993-10: 2010, CPSC 16 CFR Part 1610-2008, ASTM D5034-09, ASTM D5587-15, AAMI/ANSI PB70:2012, ASTM F1868-17, ISO9073-10-2003, ASTM D1683/D1683M-17(2018).
Key results: All performance tests (Seam strength, Breaking strength, Tear strength, Water-vapour resistance, Lint and other particles generation (material and sleeve seam), Flammability, Waterproof property, Static hydrostatic resistance) passed their respective acceptance criteria. Biocompatibility tests (Cytotoxicity, Irritation, Sensitization) also passed. No clinical study was included.
Key Metrics
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.
0
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.
November 13, 2021
Chongqing Litai Fashion Group Limited Company % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K210785
Trade/Device Name: Disposable Surgical Isolation Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: August 11, 2021 Received: August 16, 2021
Dear Eva Li:
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.
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence Murray, PhD 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
2
Indications for Use
510(k) Number (if known) K210785
Device Name Disposable Surgical Isolation Gowns
Indications for Use (Describe)
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices: provided non-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."
3
510(K) Summary
K210785
A. Applicant
Chongqing Litai Fashion Group Limited Company Address: Building D7-1, Chongqing Textile & Garment City Project, Maliu Yanjiang Development Zone, Banan District, Chongqing City Contact Person: David Ni Tel: 0086-15678607429 Email: nidewei@126.com
Date of prepared: Oct. 20th 2021
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device
Trade Name: Disposable Surgical Isolation Gowns Common Name: Surgical Isolation Gown Model: LT3
Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K202310 Wildcat PE Surgical Isolation Gown Full Back Wildcat PPE, LLC
D. Intended use of the device:
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate
4
material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 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 (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices; provided non-sterile.
E. Device Description:
Surgical Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is SMS compound non-woven fabric. It is a kind of Non- Reinforced surgical isolation gown. Disposable Surgical Isolation Gowns are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Surgical Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S, M, L, XL, XXL, and XXXL.
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Chongqing Litai Fashion Group Company | Wildcat PPE, LLC | — |
| 510(K) number | K210785 | K202310 | — |
| Model Name | Disposable Surgical Isolation Gowns | Wildcat PE Surgical Isolation Gown Full Back | — |
| Classification | Class II Device, FYC (21 CFR878.4040) | Class II Device, FYC (21 CFR878.4040) | Same |
| Intend use | Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes | Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier and Performance | same |
F. Comparison of technological characteristics between the subject and predicate devices Table 1 General Comparison
5
| | intended for use in health care facilities (AAMI PB70). The
Disposable Surgical Isolation
Gowns are single use, disposable
medical devices; provided non-
sterile. | Classification of Protective
Apparel and Surgical Drapes
Intended for Use in Health Care
Facilities (ANSI/AAMI PB70). The
Wildcat PE Surgical Isolation
Gown Full Back is a single use,
disposable medical device
provided non-sterile. | |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Material
Composition | Sleeve/body (polyethylene SMS
Nonwoven )
Cuff ( Polyester ) | Linear Low-Density Polyethylene
(LLDPE) | Similar |
| Color | Blue | Blue | same |
| Sterility | Non-Sterile | Non-Sterile | same |
| Use | Single Use; Disposable | Single Use; Disposable | same |
| Liquid Barrier
Performance
Classification
Properties | Level 3 AAMI PB70 | Level 3 AMI PB70 | same |
| Flammability of
Clothing Textiles-
16CFR Part 1610
(a) | Class I | Class I | same |
| Biocompatibility | Under the conditions of the study, the device extract was not
cytotoxic. Under the conditions of
the study, the non-polar and polar
device extracts were not found to be
an irritant.
Under conditions of the study, the
non-polar and polar device extracts
were not found to be a sensitizer | Pass: ISO 10993-1 | same |
G. Summary of Non-Clinical Test Results
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:
A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For A Irritation And Skin Sensitization
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; A
A ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
6
- A AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
- A ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state
- ▲ ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strength(sleeve seam) | ASTM D1683/D1683M-2017(2018)Method A | ≥30N(7lbf) per standard F2407-20 for level 3 | Pass |
| Breaking strength | ASTM D 5034-2009(2017), Grab method | ≥30N(7lbf) per standard F2407-20 for level 3 | Pass |
| Tear strength(N) | ASTM D 5587-2015(2019), trapezoid method | ≥20N | Pass |
| Water-vapour resistance | ASTM F 1868-2017, Sweating guarded-hotplate test | ≥30cmH2O (0.00294Kpa) | Pass |
| Lint and other particles generation in the dry state(material) | ISO 9073-10:2003, Size of particles counted:3μm-25 μm | Critical area≤4.0 Less critical area≤ 4.0 | Pass |
| Lint and other particles generation in the dry state(sleeve seam) | ISO 9073-10:2003, Size of particles counted:3μm-25 μm | Critical area≤4.0 Less critical area≤ 4.0 | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Pass |
| Water proof property(material, seam) | AATCC42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Pass |
| Static hydrostatic resistance(material, seam) | AATCC 127-2018 | ≥50 cmH2o per standard ANSI/AAMI PB70:2012 for level 3 | Pass |
Table 2 performance test
7
| Item | Proposed device | Acceptance
Criteria | Result |
|---------------|------------------------------------------------------------------------|------------------------|--------|
| Cytotoxicity | Under the conditions of
the study, the device is
non-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions of
the study, the device is
non-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions of
the study, the device is
non-sensitizing | Non-Sensitizing | PASS |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The nonclinical tests performed demonstrate that the subject device, Disposable surgical Isolation Gowns, is as safe, as effective, and performs as well as the legally marketed predicate device Wildcat PE Surgical Isolation Gown Full Back under K202310.