Disposable Surgical Gowns
Device Facts
| Record ID | K202532 |
|---|---|
| Device Name | Disposable Surgical Gowns |
| Applicant | Anhui Medpurest Medical Technology Co.,Ltd |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Aug 21, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 11135-1.
Device Story
Disposable surgical gown constructed from blue polyolefin SMS (spunbond, meltblown, spunbond) non-woven fabric. Designed for use by operating room personnel during surgical procedures to provide AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Device is single-use and disposable; provided either sterile or non-sterile (non-sterile units require EtO sterilization by re-packagers). Protects both patient and clinician by acting as a physical barrier. Used in operating room environments. Healthcare providers wear the gown to maintain sterile fields and prevent cross-contamination. Benefits include reduced risk of infection transmission during surgery.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via AAMI PB70:2012, AATCC 127 (hydrostatic pressure), AATCC 42 (water impact), ASTM D5034 (breaking strength), ASTM D5587 (tear strength), ASTM D1683 (seam strength), ASTM F1868 (water-vapor resistance), ISO 9073-10 (linting), and 16 CFR Part 1610 (flammability). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Material: Polyolefin (polypropylene) SMS non-woven fabric. Barrier Level: AAMI Level 3. Standards: ANSI/AAMI PB70:2012, ISO 10993-5/10, AATCC 127, AATCC 42, ASTM D5034, ASTM D5587, ASTM D1683, ASTM F1868, ISO 9073-10, 16 CFR 1610. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1. Form factor: Disposable gown, sizes S-XXL.
Indications for Use
Indicated for operating room personnel during surgical procedures to provide AAMI Level 3 barrier protection against microorganisms, body fluids, and particulate material. Single-use, disposable device.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Cardinal Health™ Non-Reinforced Surgical Gown (K170762)
Submission Summary (Full Text)
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August 21, 2021
Anhui Medpurest Medical Technology Co.,Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202532
Trade/Device Name: Disposable Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 15, 2021 Received: August 11, 2021
Dear Ivy Wang:
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
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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,
Clarence W. Murray III, PhD 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) K202532
Device Name Disposable Surgical Gowns
#### Indications for Use (Describe)
Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).
The Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 11135-1.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(K) Summary
# Document prepared date: 8/21/2021
# A. Applicant:
Anhui Medpurest Medical Technology Co.,Ltd Address: No.188, Wenyuan Road, Zhumeng New Zone, Anging, Anhui Province, China Contact Person: Yang Yang Tel : +86-556-5999022 Fax : +86-556-5999022
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device: Trade Name: Disposable Surgical Gowns Common Name: Surgical Gown Model(s): MDSG-1052
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
## C. Predicate device:
K170762 Cardinal Health™ Non-Reinforced Surgical Gown Cardinal Health 200, LLC
## D. Intended use of the device:
Disposable Surgical Gowns are intended to be worn by operating room personnel during
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surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
#### E. Device Description:
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary color. The gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown.
The chest front and sleeve critical zones of the Disposable Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Disposable Surgical Gown is a single use, disposable medical device that will be provided in a variety of nonsterile packaging configurations.
| Device | Proposed Device | Predicate Device | Result |
|----------------|-----------------------------------------------|-------------------------------------------------------|--------|
| Manufacturer | Anhui Medpurest Medical<br>Technology Co.,Ltd | Cardinal HealthTM | - |
| 510K number | K202532 | K170762 | - |
| Model Name | Disposable Surgical Gowns | Cardinal HealthTM Non-<br>Reinforced<br>Surgical Gown | - |
| Classification | Class II Device, FYA (21<br>CFR878.4040) | Class II Device, FYA (21<br>CFR878.4040) | Same |
#### F. Technological Characteristic Comparison
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| Intend use | Disposable Surgical Gowns | Cardinal Health™ Non-Reinforced Surgical Gown is | Same |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | are intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect the surgical patient<br>and operating room<br>personnel from the transfer<br>of microorganisms, body<br>fluids<br>and particulate material.<br>This surgical gown meets<br>the requirements of<br>AAMI Level 3 barrier<br>protection for a surgical | intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect the surgical patient and<br>operating room personnel<br>from the transfer of<br>microorganisms, body fluids<br>and particulate material. In<br>addition, this surgical gown<br>meets the requirements of<br>AAMI Level 3 barrier<br>protection for a surgical gown | |
| | gown per ANSI/AAMI<br>PB70:2012<br>Liquid barrier<br>performance and<br>classification of protective<br>apparel and drapes intended<br>for use in health care<br>facilities (AAMI PB70). The<br>Surgical Gowns are single<br>use, disposable<br>medical devices; provided<br>sterile or non-sterile. Non-<br>sterile gowns are to be sold to<br>re-packager/re-labeler<br>establishments for ethylene<br>oxide (EtO) sterilization<br>according to ISO 11135-1 prior<br>to marketing to the end users<br>and Sterile surgical gowns are<br>to be sold directly to users after<br>EtO sterilization validation to<br>ISO 11135-1. | per ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of protective<br>apparel and drapes<br>intended for use in health<br>care facilities (AAMI<br>PB70). The Cardinal<br>Health™ Non-Reinforced<br>Surgical<br>Gowns are single use,<br>disposable medical devices;<br>provided sterile and non-sterile. | |
| Material<br>Composition | Polyolefin (Polypropylene)<br>SMS nonwoven | Polyolefin (Polypropylene)<br>SMS nonwoven | Same |
| Sterility | Non-Sterile | Sterile and Non-sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Size | S,M,L,XL,XXL | M-S, M, L, XL, XXL | Same |
| Weight per<br>square(g) | $45 g/m^2$ | $31g/m^2$ (1.32 oz/yd2) | Similar |
| Tensile | MD Mean 123.4N<br>CD Mean 88.2N | MD Mean 21.57 lbs<br>CD Mean 13.6 lbs | Similar |
| Tear | MD Mean 60.4N<br>CD Mean 40.2N | MD Mean 3.47 lbs<br>CD Mean 5.63 lbs | Similar |
| Hydrostatic<br>Pressure(cm)<br>AATCC-127 | $>50 cm$ | $>50 cm$ | Same |
| Water Impact (g)<br>AATCC-42 | $\le 1.0 g$ | $\le 1.0 g$ | Same |
| Level | Level 3 | Level 3 | Same |
| Resistance to<br>blood and liquid<br>penetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| EtO/ECH<br>Residuals | Device is naturally degassing<br>for 48 hours, both EtO and<br>ECH residuals below the<br>detection limit(0.03µg/g) | No available on Predicate<br>Device's 510(k) Summary | Similar |
| Shelf-life | 3 years | No available on Predicate<br>Device's 510(k) Summary | Similar |
| Biocompatibility | Under the conditions of the study, the device extract was not<br>cytotoxic. Under the conditions of the study, the non-polar and<br>polar device extracts were not found to be an irritant.<br>Under conditions of the study, the non-polar and polar device<br>extracts were not found to be a sensitizer. | | Same |
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### G. Non-Clinical Test Conclusion
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:
- A 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
- > CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
- > AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
- A AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test;
- > ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test):
- A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- > AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities.
Table 2 - Performance Testing
| Testing Methodology | Purpose | Acceptance Criteria | Results |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------|
| Hydrostatic Pressure<br>AATCC127:2014 | The purpose of the<br>performance testing is to<br>demonstrate the<br>functionality of the<br>subject device. | ≥50cm H2O | PASS<br>3 non-consecutive lots<br>tested, using a sample<br>size of 32/lot. |
| | | | Average of 203cm on<br>Front body material,<br>168cm on back body<br>material and 60cm on<br>seam. |
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| Water-proof Property<br>AATCC42:2013 | ≤1.0g | PASS<br>3 non-consecutive lots<br>tested, using a sample<br>size of 32/lot.<br>0g on Critical Zone<br>(Body material, Sleeve<br>seam and Adhesive part<br>of belt) |
|----------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tear strength(N)<br>Trapezoid Method<br>ASTM D 5587-2015, | MD/CD≥ 10N | PASS<br>Sample size of 5 pcs<br>MD Mean 60.4N<br>CD Mean 40.2N |
| Breaking Strength<br>ASTM D 5034-<br>2009(2017) | MD/CD≥ 30N | PASS<br>Sample size of 8 pcs<br>CD Mean 88.2N |
| Sewn seam<br>strength (sleeve<br>seam) ASTM<br>D1683/D1683M-<br>2017(2018) | Seam Strength ≥ 30N | PASS<br>Sample size of 5 pcs<br>Seam Strength Mean:<br>64.5 N |
| Water-vapor<br>resistance<br>ASTM F 1868-<br>2017 | ≤3.0 Pa·m²/W | PASS<br>Sample size of 3 pcs<br>Water-vapor resistance<br>Mean: 2.42 Pa·m²/W |
| Lint and other<br>particles generation in<br>the dry state<br>ISO 9073- | Coefficient<br>of linting Log10≤ 4.0 | PASS<br>Sample size of 5 pcs<br>Log10 Mean: 3 |
| 10: 2003<br>Mass per unit area<br>ASTM<br>D3776/D3776M-<br>2009(2017) | N/A | Sample size of 5 pcs. Mas<br>per unit area Mean: 45<br>g/m² |
| Burning Behavior<br>16 CFR Part 1610 | Class I | PASS<br>Sample size of 5 pcs<br>Class I |
Table 3 Biocompatibility Testing
| Item | Purpose | Acceptance Criteria | Result |
|------|---------|---------------------|--------|
|------|---------|---------------------|--------|
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| Cytotoxicity | The purpose of the biocompatibility testing is to demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | PASS<br>Under the conditions of the study, the device is non-cytotoxic. |
|---------------|-----------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------|
| Irritation | | Non-Irritating | PASS<br>Under the conditions of the study, the device is non-irritating. |
| Sensitization | | Non-Sensitizing | PASS<br>Under the conditions of the study, the device is non-sensitizing |
### H. Clinical Test Conclusion
No clinical study is included in this submission.
#### L Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Gowns cleared under K170762.
