(104 days)
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 meet 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 Isolation Gowns are single use, disposable medical devices, provided non-sterile.
Disposable Isolation Gowns are designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The sleeve and body of the Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are 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.
The provided text describes the acceptance criteria and performance data for a medical device, specifically Disposable Isolation Gowns. However, it is not an AI/ML powered medical device. Therefore, the requested information pertaining to AI/ML model performance, such as sample sizes for test sets, data provenance, expert consensus for ground truth, MRMC studies, or training set details, is not applicable to this document.
The document focuses on demonstrating the substantial equivalence of the proposed isolation gowns to a legally marketed predicate device based on their physical properties, barrier performance, and biocompatibility.
Here's the relevant information that can be extracted, presented in the requested format where applicable:
Acceptance Criteria and Reported Device Performance for Disposable Isolation Gowns
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Performance Tests | ||
| Seam strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass |
| Breaking strength | $\ge$ 30N (7lbf) per standard F2407-20 | Pass (Mean Result MD: 85.6N, CD: 77.3 N) |
| Tear strength (N) | $\ge$ 20N | Pass (Mean Result MD: 29.9N, CD: 18.43N) |
| Lint and other particle generation in dry state | Critical area $\le$ 4.0, Less critical area $\le$ 4.0 | Pass |
| Flammability | Class I per 16 CFR Part 1610 | Pass |
| Liquid Barrier Performance Tests (AAMI Level 3) | ||
| Water proof property (material, seam) | $\le$ 1.0g AQL: 4%, Level 3 per standard ANSI/AAMI PB70:2012 (AATCC42-2017) | Pass |
| Static hydrostatic resistance | $\ge$ 50 cmH2O per standard ANSI/AAMI PB70:2012 (AATCC 127-2018) | Pass |
| Biocompatibility Endpoints Assessment | ||
| Cytotoxicity | Non-Cytotoxic | PASS |
| Irritation | Non-Irritating | PASS |
| Sensitization | Non-Sensitizing | PASS |
Points 2-9 are not applicable as this is not an AI/ML medical device submission.
- 2. Sample size used for the test set and the data provenance: Not applicable. The tests are for physical and biological properties of the gowns, not an AI/ML model. The testing is based on standard methods for material properties. The provenance is internal testing by the manufacturer (Xiamen Probtain Medical Technology Co., Ltd. in China).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical and biological tests is defined by established international standards (ISO, ASTM, AATCC, CPSC).
- 4. Adjudication method for the test set: Not applicable. Results are quantitative measurements against defined criteria.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used: For physical and barrier performance, the "ground truth" is defined by the acceptance criteria specified in the referenced industry standards (e.g., AAMI PB70:2012, ASTM, ISO, AATCC, CPSC 16 CFR). For biocompatibility, it's the biological response observed under standardized test conditions (e.g., non-cytotoxic, non-irritating, non-sensitizing).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (disposable isolation gowns). The "study" proving the device meets acceptance criteria consists of a battery of non-clinical, laboratory-based tests of the product's physical, barrier, and biocompatibility properties, demonstrating compliance with recognized standards. The concept of an "AI/ML model" and associated metrics (training/test sets, human readers, ground truth creation for AI) does not apply to this submission.
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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" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
February 8, 2023
Xiamen Probtain Medical Technology Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K223304
Trade/Device Name: Disposable Isolation Gowns (S.M.L.XL.XXL.XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: January 12, 2023 Received: January 12, 2023
Dear Jarvis Wu:
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 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.
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 Gowns (S.M.L.XL.XXL.XXXL)
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 meet 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 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)
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XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
510(K) Summary K223304
Document prepared date: 2023/02/06
A. Applicant:
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China Contact Person: Jianli Kang Tel: +86-592-7557106 Fax: +86-592-7199255 Email: kangjianli@probtain.com
Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050
Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Disposable Isolation Gowns Common Name: Surgical Isolation Gown Model: S,M,L,XL,XXL,XXXL
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:
Disposable Surgical Isolation Gowns Chongqing Litai Fashion Group Limited Company
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XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fuijan,361100, China
D. Intended use of the device:
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 meet 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 Isolation Gowns are single use, disposable medical devices, provided non-sterile.
E. Device Description:
Disposable Isolation Gowns are designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The sleeve and body of the Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are 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 | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Chongqing Litai FashionGroup Company | XIAMEN PROBTAINMEDICAL TECHNOLOGYCO., LTD | – |
| 510K number | K210785 | K223304 | – |
| Product Name | Disposable Surgical IsolationGowns | Disposable Isolation Gowns | – |
| Classification | Class II Device, FYC (21CFR878.4040) | Class II Device, FYC (21CFR878.4040) | Same |
| Intend use/Indications foruse | Disposable Surgical IsolationGowns are intended to protecthealth care patients and healthcare personnel from thetransfer of microorganisms,body fluids and particulatematerial. Not intended for usein the operating room. ThisDisposable Surgical IsolationGowns meets the requirementsof AAMI Level 3 barrierprotection for a surgicalisolation gown perANSI/AAMI PB70:2012 | Disposable Isolation Gowns areintended to protect health carepatients and health carepersonnel from the transfer ofmicroorganisms, body fluidsand particulate material. Notintended for use in the operatingroom. This Disposable IsolationGowns meet the requirementsof AAMI Level 3 barrierprotection for a surgicalisolation gown per ANSI/AAMIPB70:2012 Liquid barrierperformance and classification | Same |
| Liquid barrier performance | of protective apparel and drapes | ||
| and classification of protective | intended for use in health care | ||
| apparel and drapes intended | facilities (AAMI PB70). The | ||
| for use in health care facilities | Disposable Isolation Gowns are | ||
| (AAMI PB70). The | single use, disposable medical | ||
| Disposable Surgical Isolation | devices, provided non-sterile. | ||
| Gowns are single use, | |||
| disposable medical devices; | |||
| provided non-sterile. | |||
| Material | Sleeve/body (polyethylene | Sleeve/body (PP non-woven | |
| Composition | SMS Nonwoven ) | fabric & PE lamination) | Similar |
| Cuff (Polyester ) | Cuff (Polyester) | ||
| Color | Blue | Blue | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Liquid Barrier | |||
| Performance | |||
| Classification | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Properties | |||
| WaterPenetration | ≤1.0g AQL: 4% | ≤1.0g AQL: 4% | |
| Resistance | Level 3 per standard | Level 3 per standard | Same |
| AATCC 42 | ANSI/AAMI | ANSI/AAMI | |
| PB70:2012 for level 3 | PB70:2012 for level 3 | ||
| Static | ≥50 cmH2O per standard | ≥50 cmH2O per standard | |
| hydrostatic | ANSI/AAMIPB70:2012 for level 3 | ANSI/AAMIPB70:2012 for level 3 | Same |
| resistanceAATCC 127 | |||
| Seam strength | ≥30N(7lbf) | ≥30N(7lbf) | |
| ASTM D1683M-per standard | per standard | per standard | |
| 17 | F2407-20 for level 3 | F2407-20 for level 3 | Same |
| Breaking | ≥30N(7lbf) | ≥30N(7lbf) | |
| strength | per standard | per standard | Same |
| ASTM D5034- | F2407-20 for level 3 | F2407-20 for level 3 | |
| 09 | |||
| Tear | ≥10N | ≥10N | Same |
| strength(N) | |||
| ASTM D5587- | |||
| 15, | |||
| Flammability of | |||
| Clothing | Same | ||
| Textiles- 16CFRPart 1610 | Class I | Class I | |
| Biocompatibility | |||
| Under the conditions of the | Under the conditions of the | ||
| study, the device extract was | study, the device extract was | ||
| not cytotoxic.Under the conditions of thestudy, the non-polar and polardevice extracts were notfound to be an irritant.Under conditions of thestudy, the non-polar and polardevice extracts were notfound to be a sensitizer. | not cytotoxic.Under the conditions of thestudy, the non-polar and polardevice extracts were not foundto be an irritant.Under conditions of the study,the non-polar and polar deviceextracts were not found to be asensitizer. | Same |
F. Comparison with predicate device
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XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
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:
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In A Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; >
- A ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);F
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid A Procedure:
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective A 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
-
ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
Table 2 performance test
| Test Item | Test standard | AcceptanceCriteria | Result |
|---|---|---|---|
| Seam strength | ASTMD1683/D1683M-2017(2018)Methd A | ≥30N(7lbf)per standardF2407-20 | Pass |
| Breakingstrength | ASTM D 5034-2009(2017), Grabmethod | ≥30N(7lbf)per standardF2407-20 | Pass(Mean ResultMD: 85.6N NCD: 77.3 N) |
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XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
| Tear strength(N) | ASTM D 5587-2015(2019),trapezoid method | $\ge$ 20N | Pass(Mean Result:MD: 29.9NCD: 18.43N) |
|---|---|---|---|
| Lint and othergeneration in thedry state | ISO 9073-10:2004counted:3μm-25μm | Critical area $\le$ 4.0Less critical area $\le$4.0 | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Pass |
| Water proofproperty(material, seam) | AATCC42-2017 | $\le$ 1.0g AQL: 4%Level 3 perstandardANSI/AAMIPB70:2012 | Pass |
| Static hydrostaticresistance | AATCC 127-2018 | $\ge$ 50 cmH2o perstandardANSI/AAMIPB70:2012 | Pass |
Table3 Biocompatibility endpoints assessment
| Item | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions ofthe study, the device isnon-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation | Under the conditions ofthe study, the device isnon-irritating. | Non-Irritating | PASS |
| Sensitization | Under the conditions ofthe study, the device isnon-sensitizing | Non-Sensitizing | PASS |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the comparison and analysis above, the subject device, Disposable Isolation Gown (model: S,M,L,XL,XXL,XXXL), is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Surgical Isolation Gowns cleared under K210785.
§ 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.