← Product Code [FYA](/productcode/FYA) · K210355
# Surgical Gown, Model: surgical gown-hp-3 (K210355)
_Weihai Dishang Medical Technology Co., Ltd. · FYA · Dec 16, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K210355
## Device Facts
- **Applicant:** Weihai Dishang Medical Technology Co., Ltd.
- **Product Code:** [FYA](/productcode/FYA.md)
- **Decision Date:** Dec 16, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Indications for Use
The surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown meets the requirements for Level 3 classification. The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
## Device Story
Surgical gown-hp-3 is a single-use, disposable, non-sterile surgical gown; constructed from SMS polypropylene nonwoven material; provides ANSI/AAMI PB70 Level 3 liquid barrier protection. Intended for use by operating room personnel to protect patients and staff from cross-contamination of fluids, microorganisms, and particulates. Device is sold to repackagers/re-labelers for ethylene oxide (EtO) sterilization per ISO 11135 before reaching end users. Available in sizes S through XXXL. Performance relies on physical barrier properties; no electronic or software components.
## Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including liquid barrier performance (AATCC TM42, AATCC 127), physical strength (ASTM D5034, ASTM D5733, ASTM D1683), flammability (16 CFR 1610), and biocompatibility (ISO 10993-5, ISO 10993-10).
## Technological Characteristics
Material: SMS polypropylene nonwoven. Barrier: ANSI/AAMI PB70 Level 3. Standards: ASTM F2407-20, AATCC TM42-2017e, AATCC 127-2017, ASTM D5034-09, ASTM D5733-1999, ASTM D1683/D1683M-2011, 16 CFR 1610. Biocompatibility: ISO 10993-5, ISO 10993-10. Sterilization: Non-sterile (intended for EtO sterilization per ISO 11135). Form factor: Disposable gown, sizes S-XXXL.
## Regulatory 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
- Surgical Gown ([K202706](/device/K202706.md))
## Submission Summary (Full Text)
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December 16, 2021
Weihai Dishang Medical Technology Co., Ltd Ricky Xia Manager Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai, Shandong 264209 China
Re: K210355
Trade/Device Name: Surgical Gown, Model: surgical gown-hp-3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 10, 2021 Received: December 15, 2021
Dear Ricky Xia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 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 Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K210355
Device Name Surgical Gown, Model: surgical gown-hp-3
#### Indications for Use (Describe)
The surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
| Type of Use (Select one or both, as applicable) | For the Non-Health SET-Wellbeing Plan | For the Core Health SET-Wellbeing Plan |
|-------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | | |
| | 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
### Prepared Date: December 10, 2021
### 1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Weihai Dishang Medical Technology Co.,Ltd |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Address: | Room 406-409,Block C,No.213 Torch Road,Torch High-tech Industrial Development Zone,Weihai,Shandong China |
| Contact person: | Ricky.xia |
| Title: | Manager |
| E-mail: | ricky.xia@dishang.com |
| Tel: | +86- 18663126766 |
### 2. Device Identification
| 510(K) number: | K210355 |
|--------------------|------------------------------------------|
| Trade/Device Name: | Surgical Gown, Model: surgical gown-hp-3 |
| Common name: | Gown, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FYA |
### 3. Predicate Device
| 510(K) number: | K202706 |
|--------------------|----------------------------------------------|
| Device Name: | Surgical Gown |
| Manufacturer: | B.J.ZH.F.Panther Medical Equipment CO., LTD. |
| Common name: | Gown, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FYA |
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#### 4. Device Description
The proposed devices have a SMS design that provides a PB70:2012 level 3 Liquid Barrier Performance Barrier.
The proposed devices are single use, disposable medical devices and can be provided in nonsterile. These surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL.
#### 5. Indication for use
The Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gown is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
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### 6. Compared to Predicate Device
Compared to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device, the comparison is listed in below table:
| Comparisons | Proposed Device surgical gown-hp-3 K210355 | Predicate Device K202706 | remark |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Name | Surgical Gown | Surgical Gown (Non-sterile) | / |
| Model | surgical gown-hp-3 | / | / |
| Product code | FYA | FYA | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for use | Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification. The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gown is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user. | Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification. | Same |
| Level | 3 | 3 | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Use | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Weight per square(g) | 45 g/m² | 55 g/m² | Similar, see note 1 |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Material | SMS polypropylene nonwoven | SMS polypropylene nonwoven + Polyester | Similar, see note 1 |
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| Performance | | | | | |
|------------------|------------------------|-------------------------|--------------------------|-----------------------------------------|-----------------------------------|
| Test item | Test standard | surgical gown-hp-3 | Predicate Device K202706 | Remark | |
| Water Resistance | Impact penetration | AATCC TM42-2017e | ≤1.0g | ≤1.0g | Same Meet standard requirement |
| | Hydrostatic resistance | AATCC 127 - 2017 (2018) | ≥50cm | ≥50cm | Same Meet standard requirement |
| Tensile Strength | ASTM D5034-09(2017), | ≥30N(7 lbf) | > 20N | Meet standard requirement See note 2 | |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | > 20N | Meet standard requirement See note 2 | |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | / | Meet standard requirement See note 2 | |
| Flammability | 16 CFR Part 1610 | Class 1 | Class 1 | Same | |
| Biocompatibility | | | | |
|--------------------|-----------------------|------------------------|-----------------------------|------------|
| Test item | Test standard | surgical gown- hp-3 | Predicate Device K202706 | Remark |
| Cytotoxicity | ISO 10993- 5:2009 | No Cytotoxicity | No Cytotoxicity | Same |
| Skin sensitization | ISO 10993- 10:2010 | No Irritation | No Irritation | Same |
| Skin irritation | ISO 10993- 10:2010 | No Sensitization | No Sensitization | Same |
| Sterile | / | non-sterile | Sterile/non-sterile | See Note 3 |
Note 1: There is a little difference in material. We had evaluated performance and biocompatibility in according to ANSI AAMI PB70:2012, ASTM F2407-20, ISO 10993-5 and ISO 10993-10, and the result shows no new risk arise.
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Note 2: Because of the update of version of ASTM F2407, in new version of the standard, the
test items, tensile strength, tearing strength and seam strength are changed from optional to mandatory, and specify requirement of each test item. The subject devices meet the requirement of new version standard.
Note 3: The subject device is non-sterile surgical gown that are required processing during their use-life.
### 7. Performance Data Clinical test:
Clinical testing is not required.
#### Non-clinical data
Performance:
1. ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
2. ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
| Test item | Test standard | Criteria | surgical gown-hp-3 | |
|---------------------|----------------------------|------------------------|--------------------|---------------------------------|
| Water Resistance | Impact penetration | AATCC TM42- 2017e | ≤1.0g | Pass |
| | Hydrostatic resistance | AATCC 127 -2017 (2018) | ≥50m | Pass,Meet level 3 requirment |
| Tensile Strength | ASTM D5034-09(2017), | ≥30N(7 lbf) | Pass | |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | Pass | |
| Seam Strength | ASTM D1683/ D1683M-2011 | ≥30N(7 lbf) | Pass | |
| Flammability | 16 CFR Part 1610 | Class1 | Pass | |
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Biocompatibility:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation 2.
and skin sensitization.
| Test item | Test Standard | Criteria | Results |
|-----------------------|--------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | Under conditions of the study, the test article must not show potential toxicity. | Pass - Under the condition of the test, the test article was found to be non-toxic |
| Skin Sensitization | ISO 10993-10: 2010 | Under the conditions of the study, the test article must be found to be non-sensitizing. | Pass - Under the condition of the test, the test article was found to be non-sensitizing |
| Skin Irritation test | ISO 10993-10: 2010 | Under the conditions of the test, the test article must be found to be non- irritating | Pass - Under the conditions of the test, the test article was found to be non- irritating |
### 9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210355, the Surgical Gown, model: surgical gown-hp-3, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202706.
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**Source:** [https://fda-staging.innolitics.com/device/K210355](https://fda-staging.innolitics.com/device/K210355)
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