Medical surgical mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 26, 2021 Henan Huibo Medical Co.,Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K202842 Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2021 Received: October 20, 2021 #### Dear Boyle Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202842 Device Name Medical surgical mask Indications for Use (Describe) The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile. | 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." {3}------------------------------------------------ # 510(k) Summary 510k number: K202842 Date: Oct.14, 2021 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. #### 1.0 Submitter's information Name: Henan Huibo Medical Co.,Ltd. Address: Weishi Road Central, Nanyang New Energy Economic and Technological Development Zone, 473000 Nanyang City, Henan Province, China Phone Number: 86-400-600-0067 Fax number: 86-377-60180999 Contact: Ms. Hui Lu Date of Preparation: Sep.17, 2020 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn ### 2.0 Device information Trade name: Medical Surqical mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): Ear loop, 17.5×9.5cm ### 3.0 Classification Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surqical apparel ### 4.0 Predicate device information Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surqical Face Mask 510(k) number: K182515 {4}------------------------------------------------ #### 5.0 Indication for Use Statement The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile. #### 6.0 Device description The medical surgical mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices. #### 7.0 Non-Clinical Test Conclusion The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004. | Item | Test method | Pass Criteria | Results | |------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------| | Bacterial filtration<br>efficiency (BFE) (%) | ASTM F2101-19Standard Test<br>Method for Evaluating the Bacterial<br>Filtration | ≥98% | 32/32 Passed at<br>≥98% | | Different pressure<br>(Delta-P) | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and<br>test methods according to<br>ASTM F2100:2019 | <6.0 mmH2O/cm² | 32/32 Passed<br><6 mmH2O/cm²<br>/ Pass | | Sub-micron<br>particulate filtration<br>efficiency at 0.1<br>micron, % (PFE) | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in<br>Medical Face Masks to Penetration<br>by Particulates Using Latex<br>Spheres according to ASTM<br>F2100:2019 | ≥98% | 32/32 Passed at<br>≥98% / Pass | | Resistance to<br>penetration by | ASTM F1862M-17 Standard Test<br>Method for Resistance of Medical | 29 of 32 test<br>articles passed at | 32 of 32 test<br>articles passed | Table 1 - Performance Testing Summary {5}------------------------------------------------ | synthetic blood,<br>Minimum pressure in<br>mmHg for pass result | Face Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to ASTM<br>F2100:2019 | 120mmHg/<br>160mmHg | at 120mmHg,<br>160mmHg | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------| | Flame spread | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according<br>to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3<br>seconds burn<br>Time-Class 1 /<br>Pass | | Shelf life | Method of accelerated aging under<br>55°C for 80 days | 2 years | Pass | - Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact ● for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: 1) In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity, 2) Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization, 3) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization. # 8.0 _Clinical Test Conclusion No clinical study implemented for the Medical surgical mask. | Item | Proposed device | Predicated device | Remark | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Code | FXX | FXX | same | | Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | same | | Class | II | II | same | | Product name | Medical surgical mask | Surgical Face Mask | - | | 510(k) No. | K202842 | K182515 | - | | Models | Ear loop, 17.5×9.5cm | Ear loop | same | | Intended Use | The medical surgical mask is<br>intended to be worn to protect<br>both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. It is intended for use<br>in infection control practices | The Surgical Face Masks<br>are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in | same | # 9.0 Technological Characteristic Comparison Table {6}------------------------------------------------ | | | to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non sterile. | infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | | |--------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | OTC use | Yes | Yes | same | | Composite | | Flat Pleated, 3 layers | Flat Pleated, 3 layers | same | | Material | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | same | | | Middle layer | Melt blown polypropylene | Melt blown polypropylene | same | | | External layer | Spun-bond polypropylene | Spun-bond polypropylene | same | | | Nose piece | monofilament | Malleable polyethylene<br>wire | * Different 1 | | | Ear loop | spandex | spandex | same | | | Color | Blue | Yellow | * Different 2 | | Dimension (Length) | | $17.5cm\pm5%cm$ | $17.5cm\pm0.2cm$ | * similar 3 | | Dimension (Width) | | $9.5cm\pm5%cm$ | $9.5cm\pm0.2cm$ | * similar 4 | | Sterility | | Non-Sterile | Non-Sterile | same | | Single Use | | Yes | Yes | same | | Sterile | | No | No | same | | ASTM F2100 Level | | Level 2 / Level 3 | Level 2 | * different 5 | | Shelf life | | 2 years | No identified | * different 6 | * Gap analysis: Different 1-2: the two devices have some difference in material and product color, product materials safety is proved by its bio-compatibility, and the difference does not raise additional questions for safety and effectiveness of device. Different 3-4: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device. Different 5: the proposed device comply to level 3 at the same time, has better performance than the predicated device, the performance of proposed device is supported by its performance test, the difference does not raise additional questions for safety and effectiveness of device. Different 6: the proposed device define its 2 years shelf life and verified, the equivalence device did not its shelf life, compared with the equivalence, defined shelf life of the proposed device can have lower potential risks of over shelf life use. #### 10.0 Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device {7}------------------------------------------------ in 510(K) submission K202842, the Medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.