(56 days)
Not Found
No
The 510(k) summary describes a disposable isolation gown and its material properties and testing against standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a disposable isolation gown intended to protect against transferring microorganisms, body fluids, and particulate material, not to treat or diagnose a medical condition.
No
The device is a disposable isolation gown intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It is a barrier protection device, not one that is used to diagnose diseases or conditions.
No
The device description clearly states it is a physical garment made of Polypropylene and Polyethylene, designed for barrier protection. It is a tangible, hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that this is a Disposable Isolation Gown. Its purpose is to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier device used on the body, not for analyzing specimens.
- Intended Use: The intended use is for protection in a medical environment, not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples
- Detecting specific analytes (e.g., glucose, antibodies, DNA)
- Providing diagnostic information
Therefore, based on the provided information, this Disposable Isolation Gown is a medical device, but it is not an In Vitro Diagnostic device.
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 Gown 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 (AAM PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.
Product codes
FYC
Device Description
Disposable Isolation Gowns are designed for the medical personnel use 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 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 blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of 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
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 Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
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 results:
- Seam strength (ASTM D1683M-17): PASS (89.86 N, average result from 10 samples)
- Breaking strength (ASTM D5034-09): PASS (MD: 90.92 N, CD: 77.06 N, average result from 10 samples)
- Tear strength (ASTM D5587-15): PASS (MD: 31.89 N, CD: 19.2 N, average result from 10 samples)
- Lint and other generation in the dry state (ISO 9073-10:2003(E)): PASS (Log10(particle count)
§ 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 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.
January 4, 2023
Xiamen Probtain Medical Techology Co., Ltd Jianli Kang Vice General Manager 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen, Fujian 361100 China
Re: K223411
Trade/Device Name: Disposable Isolation Gowns (S,M,L,XL,XXL,XXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: December 12, 2022 Received: December 12, 2022
Dear Jianli Kang:
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.
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
1
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, MD, 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 Ouality 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 Gown 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 (AAM PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided 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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3
510(K) Summary
K223411
Document prepared date: 2022/12/19
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,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:
K210785
Disposable Surgical Isolation Gowns Chongqing Litai Fashion Group Limited Company
4
D. Intended use of the device/ 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 Gown 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 Isolation Gowns are single use, disposable medical devices, provided sterile.
E. Device Description:
Disposable Isolation Gowns are designed for the medical personnel use 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 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 blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of 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 | K223411 | – |
| Product Name | Disposable Surgical Isolation Gowns | Disposable Isolation Gowns | – |
| Product Code | FYC | FYC | Same |
| 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 | 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 | Same |
| 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. | 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 sterile. | |||
| Material | |||
| Composition | Sleeve/body (polyethylene | ||
| SMS Nonwoven ) | |||
| Cuff (Polyester ) | Sleeve/body (PP non-woven | ||
| fabric & PE lamination ) | |||
| Cuff (Polyester ) | Similar | ||
| Color | Blue | Blue | Same |
| Sterility | Non-Sterile | Sterile, Ethylene Oxide (EtO) | Different |
| Sterilization | |||
| Method | Not available | Ethylene Oxide (EtO) | Different |
| Sterilization | |||
| Residuals | Not available | EO ≤ 4mg/day | |
| ECH ≤ 9mg/day | Different | ||
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Liquid Barrier | |||
| Performance | |||
| Classification | |||
| Properties | Level 3 AAMI PB70 | Level 3 AMI PB70 | Same |
| Water | |||
| Penetration | |||
| Resistance | |||
| AATCC 42 | ≤1.0g AQL: 4% | ||
| Level 3 per standard | |||
| ANSI/AAMI | |||
| PB70:2012 for level 3 | ≤1.0g AQL: 4% | ||
| Level 3 per standard | |||
| ANSI/AAMI | |||
| PB70:2012 for level 3 | Same | ||
| Static | |||
| hydrostatic | |||
| resistance | |||
| AATCC 127 | ≥50 cmH2O per | ||
| standard ANSI/AAMI | |||
| PB70:2012 for level 3 | ≥50 cmH2O per | ||
| standard ANSI/AAMI | |||
| PB70:2012 for level 3 | Same | ||
| Seam strength | |||
| ASTM | |||
| D1683M-17 | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | Same | ||
| Breaking | |||
| strength | |||
| ASTM | |||
| D5034-09 | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | Same | ||
| Tear | |||
| strength(N) | ≥10N | ≥10N | Same |
| ASTM | |||
| D5587-15, | |||
| Flammability of | |||
| Clothing | |||
| Textiles- 16CFR | |||
| Part 1610 | |||
| Class I | 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 devic
extracts were not found to be a
sensitizer. | Same |
F. Comparison with predicate device
5
6
Different analysis:
The Proposed Device Disposable Isolation Gowns are provided sterile, which is different from Predicate Device's sterility. The EO and ECH Residuals tests were conducted on the proposed device to ensure its compliance to the ISO10993-7. The test result has shown the difference does not affect the safety and of the proposed device. There is no new risk generated from the difference of the sterility.
Under the conditions of each study, the Proposed Device Disposable Isolation Gowns are noncytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.
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 Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
- 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 A Textile Fabrics (Grab Test);F
A 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 A
7
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD
4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
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
| Table 2 performance test | ||
|---|---|---|
| -- | -------------------------- | -- |
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strength | |||
| ASTM D1683M-17 | |||
| Standard Test Method | |||
| for Failure in Sewn | |||
| Seams of Woven | |||
| Fabrics. | The test was performed | ||
| In accordance with | |||
| ASTM D1683M-17 | |||
| Standard. Test Method | |||
| for Seam Strength of | |||
| Textile Fabrics (Grab | |||
| Test) to evaluate Failure | |||
| in Sewn Seams of the test | |||
| sample. | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | PASS |
89.86 N
(Average result from 10
samples) |
| Breaking strength
ASTM D5034-09
(2017) Standard Test
Method for Breaking
Strength and
Elongation of Textile
Fabrics (Grab Test) | The test was performed
In accordance with
D5034-09 (2017) .
Standard. Test Method
for Breaking Strength
and Elongation of Textile
Fabrics (Grab Test) to
evaluate the
breaking strength of the
test sample. | ≥30N(7lbf)
per standard
F2407-20 for level 3 | PASS
MD: 90.92 N
CD: 77.06 N
(Average result from 10
samples) |
| Tear strength(N)
ASTM D5587-15,
Standard Test Method
for Tearing Strength of
Fabrics by Trapezoid
Procedure | The test was performed
in accordance with
ASTM D5587:
2015(2019) Standard
Test Method for Tearing
Strength of Fabrics by
Trapezoid Procedure to
evaluate
the tearing strength of the
test sample. | ≥10N | PASS
MD: 31.89 N
CD: 19.2 N
(Average result from 10
samples) |
| Lint and other
generation in the
dry state
ISO 9073- 10:2003(E) | The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10: Lint
and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample. | Log10(particle count)