(182 days)
Not Found
No
The device is a surgical isolation gown, a physical barrier, and the description focuses on material properties and barrier performance standards. There is no mention of software, data processing, or any AI/ML related terms.
No
The device is a surgical isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device is a surgical isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose medical conditions.
No
The device is a physical surgical isolation gown made of polypropylene material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the device as a "Surgical Isolation Gown" intended to "protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material." This is a barrier protection device, not a device used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, reagents, or diagnostic interpretation.
The device is a medical device, specifically a protective apparel, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
Product codes
FYC
Device Description
The proposed Surgical Isolation Gown is constructed of Polypropylene SMS non-woven material with the color in blue. The melt-blown nonwovens are made of polypropylene. The Surgical isolation gown is different in size. The size of surgical isolation gown is divided into seven groups: S(160), M(165), L(170), XL(175), XXL(180), 3XL(185), 4XL(190).
The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The device description of the Surgical Isolation Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
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
patients and health care personnel
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
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes on August, 1993 STANDARDS:
AAMI PB70:2012, Liquid Barrier Performance Classification of Protective Apparel and 0 Drapes Intended for Use in Health Care Facilities.
o ASTM D3776/D3776M-09 (2013), Test Methods for Mass Per Unit Area (Weight) of Woven Fabric.
ASTM D5034-09(2013), Standard Test Method for Breaking Strength and Elongation of ● Textile Fabrics (Grab Test).
ASTM D5587-2015, Standard Test Method for Tearing Strength of Fabrics by Trapezoid ● Procedure.
- o (CPSC), Part 1610, Standard For The Flammability Of Clothing Textiles.
- AATCC 42-2017, Water Resistance: Impact Penetration Test.
- AATCC 127-2018, Water Resistance: Hydrostatic Pressure Test. ●
- o ISO 10993- 1: 2009/(R)2013, Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process.
o 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 o Irritation And Skin Sensitization.
o ISO 9073-10:2004, Textiles-Test methods for nonwovens-Part 10: Lint and other particles generation in the dry state.
Key Metrics
Sensitizing: Non-Sensitizing
Irritation: Non-Irritating
Cytotoxicity: Non-Cytotoxic
Basic weight: 60.7 g/m2 (1.79 oz/yd2) Seam between areas C&D:
§ 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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Yanbian Pacific Textile Co., LTD % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara, California 95054
Re: K203415
Trade/Device Name: Surgical Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC, Dated: April 13, 2021 Received: April 19, 2021
Dear Rafi Wong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
For Ryan Ortega Acting 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
510(k) Number (if known)
Device Name
Surgical Isolation Gown
Indications for Use (Describe)
The Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSU AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Research Use (Part 21 CFR 601 Subpart D) |
|---|
| ☑ Source Tissue Controlled (21 CFR 601 Subpart C) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4. Indications for Use Statement
The Surgical Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The Surgical Isolation Gown is considered under the product code, FYC, under the classification of a surgical isolation gown per the new Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA on December 9, 2015 because this isolation gown has a moderate barrier protection.
The Surgical Isolation Gowns are non-sterile and provided in ONE product model in seven sizes to meet the needs of healthcare patients and health care personnel, Refer to Table 1 below. The medical device will be available in one model in S(160), M(165), L(170), XL(175), XXL(180), 3XL(185), 4XL(190) sizes.
The proposed Surgical Isolation Gown is constructed of Polypropylene SMS non-woven material with the color in blue. The Surgical Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
| Product
Name | Model
Number | Sterility | Color | Dimensions | Size |
|-------------------------------|-----------------|-----------------|-------|-------------|----------|
| Surgical
Isolation
Gown | | Non-
sterile | Blue | 105cm×125cm | S(160) |
| | | | | 110cm×130cm | M(165) |
| | 12265 | | | 115cm×135cm | L(170) |
| | | | | 120cm×140cm | XL(175) |
| | | | | 125cm×145cm | XXL(180) |
| | | | | 130cm×150cm | 3XL(185) |
| | | | | 135cm×155cm | 4XL(190) |
Table 1 Specifications and dimensions of proposed device
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510K SUMMARY
K203415
Date of Summary Prepared:
May 20, 2021
Submitter Information 1.
| Submitter Contact: | YANBIAN PACIFIC TEXTILE CO., LTD
Longjing industry concentration area, Longjing city
Jilin, China, 133400 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Submitter Contact Person: | |
| Name: | Juan Zhuang |
| Phone Number: | (+86) 138-6397-7758 |
| Email: | zhuangjuan777@126.com |
| Designated Submission Correspondent: | |
| Name: | Rafi Wong |
| Phone Number: | +1 (408) 646-6537 |
| Email: | rafi.wong@pfmfinance.com |
2. Device Name: Surgical Isolation Gown
3. Regulatory Information
| Classification Name: | Surgical Isolation Gown |
|---|---|
| Common Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FYC |
| Regulation Number: | 21 CFR 878.4040 |
4. Predicate Device
| 510K Number: | K190306 - AMD Medicom Inc. |
|---|---|
| Device Name: | AMD Ritmed AssureWear™ VersaGown |
| Cleared date: | January 17, 2020 |
5. Intended Use/Indications for Use
The Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
5
6. Device Description
The proposed Surgical Isolation Gown is constructed of Polypropylene SMS non-woven material with the color in blue. The melt-blown nonwovens are made of polypropylene. The Surgical isolation gown is different in size. The size of surgical isolation gown is divided into seven groups: S(160), M(165), L(170), XL(175), XXL(180), 3XL(185), 4XL(190).
The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The device description of the Surgical Isolation Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
7. Summary of Comparison and Technological Characteristics
| Items | Proposed Device
K203415 | Predicate Device
K190360 | Result | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------|------|
| Product
Common Name | Surgical Isolation Gown | AMD Ritmed AssureWear™
VersaGown | Difference | | |
| Manufacturer | YANBIAN PACIFIC TEXTILE CO.,LTD | AMD Medicom Inc. | - | | |
| 510K Number | K203415 | K190306 | - | | |
| Product Code | FYC | FYC | Same | | |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same | | |
| Intended
Use/Indication
for Use | The Surgical Isolation Gown is intended to
protect patients and health care personnel
from the transfer of microorganisms, body
fluids and particulate material. Not intended
for use in the operating room. In addition,
the Surgical Isolation Gown meets the
requirements of an AAMI Level 3 barrier
protection for an isolation gown per
ANSI/AAMI PB70:2012 Liquid Barrier
Performance and Classification of Protective
Apparel Drapes Intended for Use in Health
Care Facilities (ANSI/AAMI PB70). The
Surgical Isolation Gown is a single use,
disposable medical device provided non-
sterile. | AMD Ritmed AssureWear™ VersaGown is
intended to be worn by healthcare personnel
to protect health care patients and health
care personnel from the transfer of
microorganisms, body fluids and particulate
material. AssureWear™ VersaGown meets the
requirements of an AAMI Level 3 barrier
protection for an isolation gown per
ANSI/AAMI PB70:2012 Liquid Barrier
Performance Classification of Protective
Apparel Drapes Intended for Use in Health
Care Facilities (ANSI/AAMI PB70). AMD
Ritmed AssureWear™ VersaGown is a single
use, non-sterile disposable medical device
and not intended for use in operating rooms. | Similar | | |
| Materials | SMS PP + PE non-woven fabric material | PP SMS non-woven + PE | Same | | |
| Color | Blue | Blue | Same | | |
| Design | Tape Neck Closure Belt Tie
Elastic Cuffs | Thumb loop Elastic cuffs Extended cuff
(Thumb loop) Flexneck™ Tie (neck) Straight
sleeve Inclined sleeve Blue belt tie
Reinforced seams | Similar for all
designs
except for
the Flexneck
patented
design | | |
| OTC Use | Yes | Yes | Same | | |
| Single Use | Yes | Yes | Same | | |
| Sterile | No | No | Same | | |
| Level of barrier
protection
AAMI PB70 | Level 3 | Level 3 | Same | | |
| Physical and mechanical performance | | | | | |
| Basic weight
ASTM D3776 | 60.7 g/m2 (1.79 oz/yd2) Seam between
areas C&D: 0.3:2.07;>0.5:1.97
Index for Particulate Matter (IPM):1.50 | Similar | | |
| | B: Face: Measured value Coefficient of
lingting log10 Min:2.5, Max:2.9,
Mean:2.74 | Inside: Total
linting >0.3:2.16;>0.5:2.00
Index for Particulate Matter (IPM):1.35 | | | |
| | Biocompatibility | | | | |
| | Cytotoxicity
ISO 10993-5:
2009 | Non-Cytotoxic | | Non-Cytotoxic | Same |
| Irritation ISO
10993-
10: 2010 | Non-Sensitizing | Non-Sensitizing | Same | | |
| Sensitization
ISO 10993-
10: 2010 | Non-Irritating | Non-Irritating | Same | | |
Table I - General Comparison
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*The difference in the materials and colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
8. Summary of Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes on August, 1993 STANDARDS:
AAMI PB70:2012, Liquid Barrier Performance Classification of Protective Apparel and 0 Drapes Intended for Use in Health Care Facilities.
o ASTM D3776/D3776M-09 (2013), Test Methods for Mass Per Unit Area (Weight) of Woven Fabric.
ASTM D5034-09(2013), Standard Test Method for Breaking Strength and Elongation of ● Textile Fabrics (Grab Test).
ASTM D5587-2015, Standard Test Method for Tearing Strength of Fabrics by Trapezoid ● Procedure.
- o (CPSC), Part 1610, Standard For The Flammability Of Clothing Textiles.
- AATCC 42-2017, Water Resistance: Impact Penetration Test.
- AATCC 127-2018, Water Resistance: Hydrostatic Pressure Test. ●
- o ISO 10993- 1: 2009/(R)2013, Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process.
o 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 o Irritation And Skin Sensitization.
o ISO 9073-10:2004, Textiles-Test methods for nonwovens-Part 10: Lint and other particles generation in the dry state.
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Clinical Test 9.
There is no clinical study included in this submission.
10. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed device Surgical Isolation Gown is as safe, as effective, and performs as well as or better than the predicate device, the AMD Ritmed AssureWear™ VersaGown (K190306) manufactured by AMD Medicom Inc.