(85 days)
Not Found
No
The 510(k) summary describes a physical medical device (isolation gown) and its material properties and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an isolation gown intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material, not to provide therapy.
No
Explanation: The document describes a Disposable Isolation Gown, which is a protective apparel for healthcare personnel and patients, not a device used for diagnosing medical conditions. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material.
No
The device is a physical garment made of fabric, not software. The description details material composition and physical characteristics.
No, 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, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that this device is a "Disposable 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 used on the body, not for testing samples from the body.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, analytical procedures, or the analysis of biological samples, which are all hallmarks of IVD devices.
The device described is a medical device (specifically, a protective barrier device), but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Disposable 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 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 Isolation Gowns are single use, disposable medical devices; provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.
The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
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 personnel using in medical environment
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 tests were conducted to verify that the proposed device met all design specifications.
Tests performed include:
- Seam strength (sleeve seam) ASTM D1683/D1683M-2017(2018) Method A: Result - Pass; Acceptance Criteria - >=30N per standard F2407-20 for level 3
- Tensile strength ASTM D 5034-2009(2017), Grab method: Result - Pass; Acceptance Criteria - >=30N per standard F2407-20 for level 3
- Tear strength ASTM D 5587-2015(2019), trapezoid method: Result - Pass; Acceptance Criteria - >=10N
- Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back) AATCC 127-2018: Result - Pass; Acceptance Criteria - >=50cmH2O AQL: 4% 32 of 32 samples pass each location
- Lint and other particles generation in the dry state (material) ISO 9073-10:2003, Size of particles counted:3μm- 25μm: Result - Pass; Acceptance Criteria - Critical area
§ 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.
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Image /page/0/Picture/0 description: The image contains 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.
February 10, 2023
Nanning TECBOD Biological Technology Co.,Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Company Ltd. Room 1401, Dongfang Building, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K223467
Trade/Device Name: Disposable Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: November 17, 2022 Received: November 17, 2022
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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 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
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Indications for Use
Submission Number (if known)
Device Name
Disposable Isolation Gown
Indications for Use (Describe)
Disposable 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 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 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary K223467
A. Applicant
Nanning TECBOD Biological Technology Co.,Ltd. Address: Room 601 Floor 6, B2 Building, No. 19 Guokai Dadao, Naning, Guangxi, PEOPLE'S REPUBLIC OF CHINA, 530033 Contact Person: Bing Yao Chen Tel: 008613959211156 Email: tecbod@163.com
Date prepared: Feb 10th, 2023
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
K223467 Trade Name: Disposable Isolation Gown Common Name: Isolation Gown
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:
K210785 Disposable Surgical Isolation Gowns Chongqing Litai Fashion Group Limited Company Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
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D. Indications For Use:
Disposable 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 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 Isolation Gowns are single use, disposable medical devices; provided non-sterile.
E. Device Description:
Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.
The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
| Device | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Manufacturer | Chongqing Litai Fashion Group Company | Nanning TECBOD Biological Technology Co., Ltd. | - |
| 510(K) number | K210785 | K223467 | - |
| Device Name | Disposable Surgical Isolation Gown | Disposable Isolation Gown | - |
| Classification | Class II Device, FYC (21 CFR878.4040) | Class II Device, FYC (21 CFR878.4040) | Same |
| 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. | Disposable 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 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 Isolation Gowns are single use, disposable medical devices; provided non-sterile. | Same |
| Material Composition | Sleeve/body (polyethylene SMS Nonwoven) Cuff (polyester) | Sleeve/body (PP+PE compound Nonwoven) Cuff (Polyester) Seam tap (Eva) | Similar |
F. Comparison with predicate device
Table 1 General Comparison
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Tecbod Biological Technology Co., LTD
| Color | Blue | Blue | Same |
|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Shelf Life | Not specified | 2 Years | Different |
| Liquid Barrier | |||
| Performance | |||
| Classification | |||
| Properties | Level 3 AAMI PB70 | Level 3 AAMI 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. | 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. | Same |
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
| Test Name | Purpose | Test Standard | Acceptance Criteria | Result |
|---|---|---|---|---|
| Seam strength (sleeve seam) | To evaluate the strength of the sleeve seam | ASTM D1683/D1683M-2017(2018) Method A | ≥30N per standard F2407-20 for level 3 | Pass |
| Tensile strength | To evaluate the tensile strength of the test sample | ASTM D 5034-2009(2017), Grab method |
- Media Direction
- Cross Direction | ≥30N per standard F2407-20 for level 3 | Pass |
| Tear strength | To evaluate the tear resistance of the test sample | ASTM D 5587-2015(2019), trapezoid method - Media Direction
- Cross Direction | ≥10N | Pass |
| Hydrostatic pressure test (front, sleeve, sleeve seam, shoulder seam, back) | To evaluate the hydrostatic barrier property of the gown | AATCC 127-2018 | ≥50cmH2O AQL: 4%
32 of 32 samples pass each location | Pass |
| Lint and other particles generation in the dry state (material) | To evaluate the linting resistance of the test sample | ISO 9073-10:2003, Size of particles counted:3μm- 25μm | Critical area≤4.0
Less critical area≤ 4.0 | Pass |
| Lint and other particles generation in the dry state (sleeve seam) | To evaluate the linting resistance in the dry state of the sleeve seam | ISO 9073-10:2003, | Critical area≤4.0
Less critical area≤ 4.0 | Pass |
| 2 year accelerated aging | To demonstrate performance stability throughout the shelf life | ASTM F1980 - AAMI PB70:2012
a. AATCC 42 Water impact
b. AATCC 127 Hydrostatic pressure | Meets all AAMI PB70 and ASTM F3352 performance requirements - AAMI PB70:2012
a. AATCC 42 | Pass |
Table 2 performance test summary
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| | | 2) ASTM F3352
a. ASTM D5034
Tensile strength
(Machine direction and
cross direction)
b. ASTM D5733
Tear strength
(Machine direction and
cross direction)
c. ASTM D1683
Seam Strength
d. ISO 9037-10
Lint generation | ≤ 1.0 g
b. AATCC 127
≥ 50 cm H2O
2) ASTM F3352
a. ASTM D5034
≥ 30 N
(Machine direction
and cross direction)
b. ASTM D5733
≥ 10 N
(Machine direction
and cross direction)
c. ASTM D1683
≥ 30 N
d. ISO 9037-10
Coef. of linting ≤ 4.0 | Pass | | |
|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------------------------------------------------------------------------------------------------------------|------|
| | | Flammability | To evaluate the
flame resistance of
the test sample | 16 CFR Part 1610 | Class I | Pass |
| | | Water impact
resistance (front,
sleeve, sleeve seam,
shoulder seam, back) | To evaluate the
water impact
barrier property of
the gown | AATCC 42-2017 | ≤1.0g AQL: 4%
32 of 32 samples pass
each location
Level 3 per standard
ANSI/AAMI PB70:2012 for
level 3 | Pass |
| | | Cytotoxic potential | To evaluate the
cytotoxic potential
of the gown | ISO 10993-5 | Under the conditions of
the study, the device is not
cytotoxic | Pass |
| | | Irritation | To evaluate the
irritation property
of the gown | ISO 10993-10 | Under the conditions of
the study, the device is not
an irritant | Pass |
| | | Sensitization | To evaluate the
sensitization
property of the
gown | ISO 10993-10 | Under the conditions of
the study, the device is
not a sensitizer | Pass |
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
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
-
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;
- A AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
- A ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state
- A ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- A ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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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 or better than the legally marketed predicate device, Disposable Surgical Isolation Gowns, cleared under K210785.