(104 days)
Not Found
No
The device is a disposable isolation gown, a physical barrier device. The description and testing focus on material properties and barrier performance, with no mention of software, data processing, or AI/ML algorithms.
No.
The device is described as a "Disposable Isolation Gown" intended to protect from the transfer of microorganisms, body fluids and particulate material, not to treat a medical condition.
No
Explanation: The device is a Disposable Isolation Gown, intended to protect from the transfer of microorganisms, body fluids, and particulate material. It is a protective apparel, not a device used to diagnose a medical condition.
No
The device is a physical garment (isolation gown) made of polypropylene and polyethylene, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and materials of the gown, designed for protection.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, tissue) or to provide information about a patient's health status or disease.
- Performance Studies and Metrics: The performance studies and key metrics are related to the physical barrier properties and biocompatibility of the gown (strength, water resistance, flammability, irritation, etc.), not diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This disposable isolation gown does not perform any such function.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FYC
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.
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 in 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 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;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure:
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for performance include:
Seam strength: >= 30N(7lbf) per standard F2407-20 (Pass)
Breaking strength: >= 30N(7lbf) per standard F2407-20 (Pass, Mean Result MD: 85.6N N CD: 77.3 N)
Tear strength(N): >= 20N (Pass, Mean Result: MD: 29.9N CD: 18.43N)
Lint and other generation in the dry state: Critical area = 50 cmH2o per standard ANSI/AAMI PB70:2012 (Pass)
Biocompatibility: Cytotoxicity (Non-Cytotoxic - PASS), Irritation (Non-Irritating - PASS), Sensitization (Non-Sensitizing - PASS)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). 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.
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.
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
2
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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3
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
4
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 Fashion | ||
| Group Company | XIAMEN PROBTAIN | ||
| MEDICAL TECHNOLOGY | |||
| CO., LTD | – | ||
| 510K number | K210785 | K223304 | – |
| Product Name | Disposable Surgical Isolation | ||
| Gowns | Disposable Isolation Gowns | – | |
| Classification | Class II Device, FYC (21 | ||
| CFR878.4040) | Class II Device, FYC (21 | ||
| CFR878.4040) | Same | ||
| Intend 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 | |||
| isolation gown per | |||
| ANSI/AAMI PB70:2012 | 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 | 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 | |||
| Water | |||
| Penetration | ≤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/AAMI | ||
| PB70:2012 for level 3 | ANSI/AAMI | ||
| PB70:2012 for level 3 | Same | ||
| resistance | |||
| AATCC 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- 16CFR | |||
| Part 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 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. | 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 |
F. Comparison with predicate device
5
6
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 | Acceptance
Criteria | Result |
|----------------------|--------------------------------------------|----------------------------------------|----------------------------------------------------|
| Seam strength | ASTM
D1683/D1683M-
2017(2018)Methd A | ≥30N(7lbf)
per standard
F2407-20 | Pass |
| Breaking
strength | ASTM D 5034-
2009(2017), Grab
method | ≥30N(7lbf)
per standard
F2407-20 | Pass
(Mean Result
MD: 85.6N N
CD: 77.3 N) |
7
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: 29.9N
CD: 18.43N) |
|--------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------|
| Lint and other
generation in the
dry state | ISO 9073-10:2004
counted:3μm-25
μm | Critical area $\le$ 4.0
Less critical area $\le$
4.0 | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Pass |
| Water proof
property(material
, seam) | AATCC42-2017 | $\le$ 1.0g AQL: 4%
Level 3 per
standard
ANSI/AAMI
PB70:2012 | Pass |
| Static hydrostatic
resistance | AATCC 127-2018 | $\ge$ 50 cmH2o per
standard
ANSI/AAMI
PB70:2012 | Pass |
Table3 Biocompatibility endpoints assessment
| 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
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.