← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K221819 # 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown (K221819) _Winner Medical Co., Ltd. · FYA · Sep 19, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K221819 ## Device Facts - **Applicant:** Winner Medical Co., Ltd. - **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md) - **Decision Date:** Sep 19, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/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 the end users after EtO sterilization to ISO 11135-1. ## Device Story Single-use, disposable surgical gowns; worn by operating room personnel during surgical procedures. Protects patient and personnel from transfer of microorganisms, body fluids, and particulate material. Available in two material types: SMMS (35g, 43g, 50g) and BVB (64g). SMMS gowns available in standard or reinforced styles; BVB gowns are standard. Provided in six sizes (M, L, LL, XL, XLL, XXL). Supplied sterile or non-sterile (non-sterile requires EtO sterilization per ISO 11135-1 before use). Barrier performance meets ANSI/AAMI PB70:2012 levels 2, 3, or 4 depending on model. Healthcare providers select gown based on required barrier level for the procedure. ## Clinical Evidence No clinical data; bench testing only. Performance verified against ANSI/AAMI PB70:2012, ASTM F2407-20, and ISO 10993 standards. Testing included flammability, hydrostatic pressure, water impact, linting, seam/breaking/tearing strength, air permeability, viral barrier (for BVB), and EO residuals. ## Technological Characteristics Materials: SMMS non-woven (polyester, nylon, PP, PE) and BVB. Energy source: None. Connectivity: None. Sterilization: Ethylene Oxide (ISO 11135-1). Form factor: Surgical gown, six sizes. Barrier levels: AAMI PB70:2012 Levels 2, 3, 4. ## 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 - Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown ([K211422](/device/K211422.md)) - SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown ([K192290](/device/K192290.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: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States. September 19, 2022 Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai, 200120 China Re: K221819 Trade/Device Name: 35g Standard Surgical Gown; 35g Reinforced SMMS Surgical Gown; 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: May 18, 2022 Received: June 23, 2022 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 {1}------------------------------------------------ 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 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, Bifeng Qian, M.D., Ph.D. 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}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) ### K221819 #### Device Name 35g Standard SMMS Surgical Gown, 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown, 50g Reinforced SMMS Surgical Gown, BVB Surgical Gown #### Indications for Use (Describe) 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/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 the end 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: _K221819_ - 1. Date of Preparation: 09/19/2022 - 2. Sponsor Identification # Winner Medical Co., Ltd. Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109 Establishment Registration Number: 9616433 Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnermedical.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person) ### 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 {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown: 43g Standard SMMS Surgical Gown; 43g Reinforced SMMS Surgical Gown; 50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown; BVB Surgical Gown Common Name: Surgical Gown ## Regulatory Information Classification Name: Gown, Surgical Classification: II Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital Indications for Use: 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. 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 the end users after EtO sterilization validation to ISO 11135-1. ## Device Description: The proposed devices 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. The proposed devices are single use, disposable medical devices {5}------------------------------------------------ and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL. The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4. | Proposed device | Size | Gram weight | Color | Style | AAMI Level | Sterilization | |-----------------------------------|------------------------|-------------|-------|------------|------------|---------------------| | 35g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 35 g/m² | Blue | Standard | 2 | Sterile/Non-sterile | | 35g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 35 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile | | 43g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 43 g/m² | Blue | Standard | 3 | Sterile/Non-sterile | | 43g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 43 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile | | 50g Standard SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 50 g/m² | Blue | Standard | 3 | Sterile/Non-sterile | | 50g Reinforced SMMS Surgical Gown | M, L, LL, XL, XLL, XXL | 50 g/m² | Blue | Reinforced | 3 | Sterile/Non-sterile | | BVB Surgical Gown | M, L, LL, XL, XLL, XXL | 64 g/m² | Blue | Standard | 4 | Sterile/Non-sterile | Table 1. Specification {6}------------------------------------------------ #### ડ. Identification of Predicate Devices Predicate Device 1 510K Number: K211422 Trade Name: Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown Level 3 Reinforced Surgical Gown Predicate Device 2 510K Number: K192290 Trade Name: SMS Standard Surgical Gown SMS Surgical Gown with Reinforcement BVB Surgical Gown (used as predicate device 2) BVB Splicing Surgical Gown #### Summary of Technological characteristics 6. | Item | Proposed Device
K221819 | Predicate Device 1
K211422 | Remark | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product
Name | 35g Standard SMMS Surgical Gown,
35g Reinforced SMMS Surgical Gown,
43g Standard SMMS Surgical Gown,
43g Reinforced SMMS Surgical Gown,
50g Standard SMMS Surgical Gown,
50g Reinforced SMMS Surgical Gown | Level 2 Standard Surgical Gown,
Level 3 Standard Surgical Gown, /
Level 3 Reinforced Surgical Gown | | | Product Code | FYA | FYA | Same | | Regulation
No. | 21CFR 878.4040 | 21CFR 878.4040 | Same | | Class | II | II | Same | | Indication for
Use | 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. | 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. | Same | | | Per ANSI/AAMI PB70:2012 Liquid | Per ANSI/AAMI PB70:2012 Liquid | | ## Table 2. General Comparison for SMMS Surgical Gown {7}------------------------------------------------ | | barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification. | barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification. | | |----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Style | Standard/Reinforced | Non-reinforced/Reinforced | Same | | Use | Single use, disposable | Single use, disposable | Same | | Color | Blue | Blue | Same | | Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same | Table 3. Safety and Effectiveness Comparison for SMMS Surgical Gown | Item | Proposed Device
K221819 | Predicate Device 1
K211422 | Remark | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product Name | 35g Standard SMMS Surgical Gown,
35g Reinforced SMMS Surgical Gown,
43g Standard SMMS Surgical Gown,
43g Reinforced SMMS Surgical Gown,
50g Standard SMMS Surgical Gown,
50g Reinforced SMMS Surgical Gown | Level 2 Standard Surgical Gown,
Level 3 Standard Surgical Gown, /
Level 3 Reinforced Surgical Gown | | | Weight
per
square (g) | 35g Standard SMMS Surgical Gown
and 35g Reinforced SMMS Surgical
Gown: 35g/m²
43g Standard SMMS Surgical Gown
and 43g Reinforced SMMS Surgical
Gown: 43g/m²
50g Standard SMMS Surgical Gown
and 50g Reinforced SMMS Surgical
Gown: 50g/m² | Level 2 Standard Surgical Gown:
35g/m²
Level 3 Standard Surgical Gown:
43g/m²
Level 3 Reinforced Surgical Gown:
35g/m² and 28g/m² | Different | | Size | M, L, LL, XL, XLL, XXL | XS, S, M, L, XL, XXL, XXXL | Different | | Flammability | Class I | Class I | Same | | Hydrostatic
pressure | 35g Standard SMMS Surgical Gown
(Non-sterile): Average 40.57cm; | Level 2 Standard Surgical
Gown: >20 cm; | Different | | | 35g Standard SMMS Surgical Gown | Level 3 Standard Surgical | | | | (Sterile): Average 40.21cm; | Gown: >50 cm; | | | | 35g Reinforced SMMS Surgical Gown | Level 3 Reinforced Surgical | | | | (Non-sterile): Average 83.53cm; | Gown: >50 cm | | | | 35g Reinforced SMMS Surgical Gown
(Sterile): Average 83.57cm; | | | | | 43g Standard SMMS Surgical Gown
(Non-sterile): Average 60.50 cm; | | | | | 43g Standard SMMS Surgical Gown
(Sterile): Average 60.48 cm; | | | | | 43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 99.59 cm; | | | | | 43g Reinforced SMMS Surgical Gown
(Sterile): Average 98.90 cm; | | | | | 50g Standard SMMS Surgical Gown
(Non-sterile): Average 83.19 cm; | | | | | 50g Standard SMMS Surgical Gown
(Sterile): Average 83.02 cm; | | | | | 50g Reinforced SMMS Surgical Gown
(Non-sterile): Average 108.37 cm; | | | | | 50g Reinforced SMMS Surgical Gown
(Sterile): Average 108.37 cm; | | | | Water impact | 35g Standard SMMS Surgical Gown
(Non-sterile): Average 0.041g; | ≤1.0 g | Different | | | 35g Standard SMMS Surgical Gown
(Sterile): Average 0.03g; | | | | | 35g Reinforced SMMS Surgical Gown
(Non-sterile): Average 0.03g; | | | | | 35g Reinforced SMMS Surgical Gown
(Sterile): Average 0.029g; | | | | | 43g Standard SMMS Surgical Gown
(Non-sterile): Average 0.036g; | | | | | 43g Standard SMMS Surgical Gown
(Sterile): Average 0.033g; | | | | | 43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 0.032g; | | | | | 43g Reinforced SMMS Surgical Gown
(Sterile): Average 0.032g; | | | | | 50g Standard SMMS Surgical Gown
(Non-sterile): Average 0.031g; | | | | Breaking
strength | 50g Standard SMMS Surgical Gown (Sterile): Average 0.034g;
50g Reinforced SMMS Surgical Gown (Non-sterile): Average 0.033g
50g Reinforced SMMS Surgical Gown (Sterile): Average 0.031g
35g Standard SMMS Surgical Gown (Non-sterile):
Latitude: 108.37N;
Longitude: 161.87N;
35g Standard SMMS Surgical Gown (Sterile):
Latitude: 108.37N
Longitude: 161.87N;
35g Reinforced SMMS Surgical Gown (Non-sterile):
Latitude: 108.72N
Longitude: 161.19N;
35g Reinforced SMMS Surgical Gown (Sterile):
Latitude: 108.53N
Longitude: 161.31N; | | | | | 43g Standard SMMS Surgical Gown (Non-sterile):
Latitude: 113.34N
Longitude: 182.30N;
43g Standard SMMS Surgical Gown (Sterile):
Latitude: 113.01N
Longitude: 181.05 N;
43g Reinforced SMMS Surgical Gown (Non-sterile):
Latitude: 113.72N
Longitude: 181.14 N;
43g Reinforced SMMS Surgical Gown (Sterile):
Latitude: 112.60N
Longitude: 181.26N;
50g Standard SMMS Surgical Gown (Non-sterile): | >20N | Different | | Tearing
strength | Latitude: 137.58N
Longitude: 190.87 N;
50g Standard SMMS Surgical Gown
(Sterile):
Latitude: 137.77N
Longitude: 188.30 N;
50g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 138.02N
Longitude: 191.32N;
50g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 138.39N
Longitude: 190.07 N;
35g Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 32.49 N
Longitude: 39.67 N;
35g Standard SMMS Surgical Gown
(Sterile):
Latitude: 32.31N
Longitude: 39.81N;
35g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 32.44N
Longitude: 39.67N;
35g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 32.55N
Longitude: 39.92N;
43g Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 33.99N
Longitude: 41.40N;
43g Standard SMMS Surgical Gown
(Sterile):
Latitude: 33.92N
Longitude: 41.75N;
43g Reinforced SMMS Surgical Gown
(Non-sterile) | >20N | Different | | | Latitude: 34.09N
Longitude: 41.51;
43g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 34.01N
Longitude: 41.18N;50g
Standard SMMS Surgical Gown
(Non-sterile):
Latitude: 44.02N
Longitude: 54.18N;
50g Standard SMMS Surgical Gown
(Sterile):
Latitude: 44.36N
Longitude: 54.07N;
50g Reinforced SMMS Surgical Gown
(Non-sterile):
Latitude: 43.93N
Longitude: 53.96N;
50g Reinforced SMMS Surgical Gown
(Sterile):
Latitude: 44.30N
Longitude: 54.25N;
35g Standard SMMS Surgical Gown
(Non-sterile): Average 41.90N
35g Standard SMMS Surgical Gown
(Sterile): Average 42.21N
35g Reinforced SMMS Surgical Gown
(Non-sterile): Average 41.75N
35g Reinforced SMMS Surgical Gown
(Sterile): Average 41.74N
43g Standard SMMS Surgical Gown
(Non-sterile): Average 44.51N
43g Standard SMMS Surgical Gown
(Sterile): Average 44.56N
43g Reinforced SMMS Surgical Gown
(Non-sterile): Average 44.55N
43g Reinforced SMMS Surgical Gown
(Sterile): Average 44.34N
50g Standard SMMS Surgical Gown
(Non-sterile): Average 50.52N | >30N | Different | | Seam strength | | | | | 50g Standard SMMS Surgical Gown
(Sterile): Average 50.45N
50g Reinforced SMMS Surgical Gown
(Non-sterile): Average 50.45N
50g Reinforced SMMS Surgical Gown
(Sterile): Average 50.57N | | | | | Linting | Log10(particle count) <4 | Log10(particle count) <4 | Same | | Air
permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same | | Barrier
protection
level | Level 2 and 3 per AAMI PB 70… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K221819](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K221819) **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