Surgical Gown (Sterile), Surgical Gown (Non-sterile)
Device Facts
| Record ID | K202706 |
|---|---|
| Device Name | Surgical Gown (Sterile), Surgical Gown (Non-sterile) |
| Applicant | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Dec 31, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications 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.
Device Story
Surgical gown designed for use by operating room personnel during surgical procedures. Acts as physical barrier to prevent transfer of microorganisms, body fluids, and particulate material between patient and staff. Single-use, disposable device available in sterile and non-sterile versions; non-sterile versions require EO sterilization before use. Available in six sizes (S-XXXL). Provides Level 3 liquid barrier protection per ANSI/AAMI PB70:2012. Used in clinical/surgical settings to enhance infection control and patient safety.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Materials: SMS polypropylene nonwoven and polyester. Level 3 barrier protection per ANSI/AAMI PB70:2012. Standards: 16 CFR 1610 (flammability), AATCC 127 (hydrostatic pressure), AATCC 42 (water impact), ISO 9073-10 (linting), ASTM D1683/D5587/D5034 (seam/tear/breaking strength), ASTM D737 (air permeability), ASTM F88/F1929 (packaging seal), ISO 10993-5/7/10 (biocompatibility/sterilization residuals). Sterilization: EO for non-sterile versions.
Indications for Use
Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material. Meets ANSI/AAMI PB70:2012 Level 3 classification.
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
- 50g SMS Standard Surgical Gown; 45g SMS Surgical Gown with Reinforcement; 68g BVB Surgical Gown (K192290)
Reference Devices
- Surgical Gown (K172987)
Submission Summary (Full Text)
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December 31, 2020
B.J.ZH.F.Panther Medical Equipment CO., LTD. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China
Re: K202706
Trade/Device Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 23, 2020 Received: December 3, 2020
Dear Diana Hong:
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 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.
For: Elizabeth F. Claverie-Williams, MS 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K202706
Device Name
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
Indications for Use (Describe)
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.
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 K202706
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202706
- 1. Date of Preparation: 12/30/2020
- 2. Sponsor Identification
# B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.
Floor 3, Building 1, 28 Huoju Street, Changping Science and Technology Park, Changping District, 102200 Beijing, China
Establishment Registration Number: 3008388437
Contact Person: Wenyue Han Position: International Regulatory Affair Tel: +86-10-80789058 Fax: +86-10-80789028 Email: wenyue.han@pantherhealthcare.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- 4. Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
- ર. Identification of Proposed Device
Trade Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Common Name: Surgical Gown
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### 510(k) Summary
## Regulatory Information
Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
### 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.
### Device Description:
The proposed devices 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.
#### Identification of Predicate Device 6.
510K Number: K192290 Product Name: 50g SMS Standard Surgical Gown; 45g SMS Surgical Gown with Reinforcement; 68g BVB Surgical Gown;
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# 68g BVB Splicing Surgical Gown
#### 7. Identification of Reference Device
510(k) Number: K172987 Product Name: Surgical Gown
#### 8. Technological Characteristic Comparison Tables.
| Item | Subject Device K202706 | Predicate Device K192290 | Reference Device K172987 | Remark |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | FYA | FYA | FYA | Same |
| Regulation<br>No. | 21CFR 878.4040 | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | II | Same |
| Indication for<br>Use | Surgical gowns are intended<br>to be worn by operating<br>room personnel during<br>surgical procedure to protect<br>both the surgical patient and<br>the operating room<br>personnel from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material.<br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use in<br>health care facilities, the<br>surgical gowns met the<br>requirements for Level 3<br>classification. | Surgical gown is intended to<br>be worn by operating room<br>personnel during surgical<br>procedure to protect both the<br>surgical patient and the<br>operating room personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. Per ANSI/AAMI<br>PB70:2012 Liquid barrier<br>performance and<br>classification of protective<br>apparel and drapes intended<br>for use in health care<br>facilities, SMS Standard<br>Surgical Gown and SMS<br>Surgical Gown with<br>Reinforcement met the<br>requirements for Level 3<br>classification; BVB Surgical<br>Gown and BVB Splicing<br>Surgical Gown met the<br>requirements for Level 4<br>classification. | Surgical gown is intended to<br>be worn by operating room<br>personnel during surgical<br>procedure to protect both the<br>surgical patient and the<br>operating room personnel<br>from transfer of<br>microorganisms, body fluids,<br>and particulate material.<br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of<br>protective apparel and drapes<br>intended for use in health<br>care facilities, the AG series<br>surgical gowns met the<br>requirements for Level 3<br>classification. | Similar |
| Style | Non-reinforced | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Similar |
| Durability | Disposable | Disposable | Disposable | Same |
### Table 1 Technological Characteristic Comparison
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| Color | Blue | Blue | Blue | Same |
|----------|--------------------------------|--------------------------------|--------------------------------|------|
| Labeling | Conform with 21CFR Part<br>801 | Conform with 21CFR Part<br>801 | Conform with 21CFR Part<br>801 | Same |
| Item | Subject Device K202706 | Predicate Device K192290 | Reference Device K172987 | Remark |
|-----------------------------|-------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------|---------|
| Weight<br>per<br>square (g) | 55g/m² | 50g/m², 45g/m², 68g/m² | 44g/m² | Similar |
| Size | S, M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL,<br>XXXL-XLONG | XL | Similar |
| Flammability | Class I | Class I | Class I | Same |
| Hydrostatic<br>pressure | >50 cm | >50 cm | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | ≤1.0 g | Same |
| Breaking<br>strength | >20N | >20N | >20N | Same |
| Tearing<br>strength | >20N | >20N | >30N | Similar |
| Linting | Log10<4 | Log10<4 | Log10<4 | Same |
| Air<br>permeability | >30 ft³/min/ft² | >15cm³/s/cm²<br>(29 ft³/min/ft²) | >30 ft³/min/ft² | Similar |
| Material | SMS polypropylene<br>nonwoven + Polyester | SMS nonwoven, Laminated<br>material, white knitted cuff, white<br>spun-bond, and BVB | SMS<br>polypropylene<br>nonwoven | Similar |
| Level | Level 3 per AAMI PB 70 | Level 3, Level 4 per AAMI<br>PB 70 | Level 3 per AAMI PB 70 | Similar |
| Biocompatibility | | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Irritation | No Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | No Sensitization | |
| Sterile | Sterile/Non-sterile | Sterile | Non-sterile | Similar |
# Table 2 Technological Characteristic Comparison
#### 9. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed subject device complies with the following standards:
- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- AATCC 127:2017 Water Resistance: Hydrostatic Pressure Test; >
- ア AATCC 42:2017 Water Resistance: Impact Penetration Test;
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- > ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
- > ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
- > ASTM D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- > ASTM D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
- > ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics;
- > ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- > ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- > ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals:
- > 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;
# 10. Clinical Test Conclusion
No clinical study is included in this submission.
# 11. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device.
