← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K210215 # Surgical Gowns (K210215) _Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · FYA · Jul 7, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K210215 ## Device Facts - **Applicant:** Jiangsu Province Jianerkang Medical Dressing Co., Ltd. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Jul 7, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Surgical gown 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. ## Device Story Disposable surgical gown made of SMS non-woven fabric; features adhesive taped seams, hook and loop neck closure, waist tie, and knit cuffs. Worn by operating room personnel during surgical procedures to provide a physical barrier against microorganisms, body fluids, and particulates. Protects both patient and wearer. Evaluated for liquid barrier performance (AAMI Level 3), tensile strength, tearing strength, and biocompatibility. Sterilized via ethylene oxide (EO). ## Clinical Evidence Bench testing only. No clinical data. Performance testing included AATCC 42 (spray impact), AATCC 127 (hydrostatic pressure), ANSI/AAMI PB70:2012 (liquid barrier), ASTM D5733 (tearing strength), ASTM D5034 (tensile strength), and ASTM 1683 (seam strength). Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization, irritation) confirmed non-cytotoxic, non-sensitizing, and non-irritating properties. ## Technological Characteristics Material: SMS non-woven fabric (45g/sqm). Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Standards: AATCC 127 (>50 cm hydrostatic pressure), AATCC 42 (<1 impact penetration), ASTM D5034 (tensile), ASTM D5733 (tearing), ASTM D1683 (seam strength), 16 CFR Part 1610 (Class 1 flammability). Biocompatibility: ISO 10993-1, 10993-5, 10993-10. Sterilization: Ethylene Oxide (EO). ## 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 XuChang ZhengDe Environstar Medical Products Co., Ltd ([K141467](/device/K141467.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. 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July 7, 2021 Jiangsu Province Jianerkang Medical Dressing Co., Ltd Tang Hongfang Quality System Director No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou, Jiangsu 213251 China Re: K210215 Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 20, 2021 Received: June 24, 2021 Dear Tang Hongfang: 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-reporting- combination-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, Ryan Ortega, PhD 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210215 Device Name Surgical Gown Indications for Use (Describe) Surgical gown 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. Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo appears to be designed to convey a sense of nature and fluidity. # 510(k) Summary ## K210215 In accordance with 21 CFR 807.92 the following summary of information is provided: ### 1. SUBMITTER Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town,213251 Jintan Changzhou City, PEOPLE'S REPUBLIC OF CHINA Phone: +86-519-82444628 Fax: +86-519-82444750 Primary Contact Person: Hongfang Tang Quality System Director Jiangsu Province Jianerkang Medical Dressing Co., Ltd Tel: (+86)-519-8244 4628 Fax: (+86) -519-8244 4745 June 20 , 2021 Date prepared: 2. DEVICE | Device Name: | Surgical Gown | |-----------------------|------------------| | Common name: | Gown, Surgical | | Classification Names: | Surgical apparel | | Model: | | | Regulation number | 21 CFR 878.4040 | | Regulation Class: | 2 | | Product Code: | FYA | - 3. PREDICATE DEVICE K141467, Surgical gown XuChang ZhengDe Environstar Medical Products Co., Ltd This predicate has not been subject to a design-related recall. #### DEVICE DESCRIPTION 4. The surgical gown is 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. It is made of soft, air permeable SMS non-woven fabric. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a green leaf-like shape on the top left and a blue wave-like shape on the bottom right. The green and blue shapes are intertwined, creating a sense of harmony and balance. Below the shapes, the word "JIANERKANG" is written in blue, indicating the name of the organization or brand associated with the logo. The logo appears to be designed to convey a message of nature, health, or environmental consciousness. The device description of the Jianerkang Surgical Gowns is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015. The Jianerkang Surgical Gown is made of a laminate with adhesive taped seams and have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes. #### 5. ம் INDICATIONS FOR USE Surgical gown 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. | Specification | Predicate Device | Proposed | Conclusion | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | K number | K141467 | K210215 | - | | Manufacturer | XuChang ZhengDe Environstar Medical
Products Co., Ltd | Jiangsu Province Jianerkang Medical
Dressing Co., Ltd | - | | Indication for
Use | Surgical gown 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. | Surgical gown 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. | same | | Material | SMS | SMS | same | | Weight per
square (g) | 45 | 45 | same | | Durability | Disposable | Disposable | same | | Size | M-S, M, L, XL, XXL | M-S, M, L, XL, XXL | same | | Color | Blue | Blue | same | | Style | Reinforced and non reinforced | non reinforced | similar | | Specification | Predicate Device | Proposed | Conclusion | | Hydrostatic
pressure:
AATCC 127 | >50 cm | >50 cm | same | | Impact
penetration:
AATCC 42 | <1 | <1 | same | | Biocompatibi
lity | under the conditions of the study, not
an irritant; (ISO 10993-10:2010) | under the conditions of the study, not
an irritant; (ISO 10993-10:2010) | same | | | under conditions of the study, not a
sensitizer; (ISO 10993-10:2010) | under conditions of the study, not a
sensitizer; (ISO 10993-10:2010) | same | | | Under the conditions of the study the
device is non-cytotoxic. (ISO 10993-5:
2009) | Under the conditions of the study the
device is non-cytotoxic. (ISO 10993-5:
2009) | same | | Tensile
strength:
ASTM D 5034 | Length(Ibf): 17.7
Width(Ibf): 25.7 | Length(Ibf): 17.1
Width(Ibf): 26.8 | Similar | | Tearing
strength:
ASTM D 5733 | Length yarns torn(lbf): 4.7
Width yarns torn(lbf): 9.8 | Length yarns torn(lbf): 3.0
Width yarns torn(lbf): 5.1 | Similar-, the
difference does
not impact the
product's safety
and performance | | Seam
strength:
ASTM D 1683 | Armhole seam (Ibf) 17.6(F.B.)
Shoulder seam (Ibf) 9.5(F.B.) | Armhole seam (Ibf) 19.4(F.B.)
Shoulder seam (Ibf) 13.4(F.B.) | Similar | | Flammability:
16 CFR Part
1610 | Class 1 | Class 1 | same | | Sterilization
method | EO | EO | same | | Resistance to
blood and
liguid
penetration | Level 3 per AAMI PB70 | Level 3 per AAMI PB70 | same | #### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with a green leaf-like shape on the left and a blue wave-like shape on the right. The green shape is larger and partially overlaps the blue shape. Below the shapes, the text "JIANERKANG" is written in a sans-serif font. The logo appears to represent a combination of nature and water, possibly suggesting a focus on health or environmental sustainability. ## 7. Summary of non-clinical performance tests ## The following performance data were provided in support of the substantial equivalence determination. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with two distinct elements. On the left, there is a green leaf-like shape, and on the right, there is a blue wave-like shape. Below these elements, the text "JIANERKANG" is written in a simple, sans-serif font. ### Biocompatibility testing The biocompatibility evaluation for the Surgical Gown was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: - Cytotoxicity - (ISO 10993-5: 2009) - Sensitization - (ISO 10993-10:2010) - Skin Irritation - (ISO 10993-10:2010) ### Performance testing Performance testing was conducted on the Surgical Gown. All of the tested parameters met the predefined acceptance criteria. | Standards | Purpose | Acceptance Criteria | Results | |-------------------------------------|------------------------------------------------------------------------------------------------|---------------------|---------| | AATCC 42 | Spray Impact | Water Resistance | PASS | | AATCC 127 | Hydrostatic Pressure | Water Resistance | PASS | | ANSI/AAMI PB70:2012
AAMI Level 3 | Liquid Barrier Performance | Water Resistance | PASS | | ASTM D 5733 | Standard Test Method for Tearing
Strength of Nonwoven Fabrics by the
Trapezoid Procedure | Tearing Strength | PASS | | ASTM D5034 –2017 | Grab Tensile, Peak Stretch, and Peak
Energy - Nonwovens | Tensile Strength | PASS | | ASTM 1683-17 (2018) | Standard Test Method for Failure in
Sewn Seams of Woven Apparel Fabrics | Seam Strength | PASS | #### 8. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210215, Jiangsu Province Jianerkang Medical Dressing Co., Ltd Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K141467. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K210215](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K210215) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com