Disposable Medical Surgical Face Mask

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June 16, 2021 Guangdong Haiou Medical Apparatus Co., Ltd. % Salon Chen System Engineer IMD Medical & Drug technology service institutions Tianbao office room 225,Sha Tai Road No.209 ShenZhen city, Guangdong Province 518117 China Re: K203200 Trade/Device Name: Disposable Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 13, 2021 Received: May 13, 2021 Dear Salon Chen: 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-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, Clarence W. Murray, III, Ph.D. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203200 Device Name Disposable Medical Surgical Face Mask ### Indications for Use (Describe) Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids. 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ ## 510(k) Summary ### 1. Submitter's Information - > Company Name: Guangdong Haiou Medical Apparatus Co., Ltd. - > Establishment Registration Number: 3010596027 - > Address:Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China - > Phone:+86-663-2758666 - > Fax: +86-663-2905999 - Contact Person(Title):Zhang Zhuo Xuan(General Manager) > - ア E-mail: hoyl@haiou.net.cn - Device Information 2. - > Trade Name: Disposable Medical Surgical Face Mask - > Common Name: Mask,Surgical - > Classification Name: Surgical Apparel - > Model: HO-KZ01 - > 510(k) Number: K203200 - Classification 3. - > Classification Product Code: FXX - > Regulation Number: 21 CFR 878.4040 - > Classification: Class II - > Review Panel: General Hospital - Predicate Device Information: 4. {4}------------------------------------------------ - 510(k) Number: K201137 > - > Predicate Device Name: ASEPT® Surgical Face Mask - > Manufacturer: PFM Medical, Inc. - > This predicate has not been subject to a design-related recall - > No reference devices were used in this submission. #### 5. Application Correspondent - > Company Name: IMD Medical & Drug technology service institutions - > Phone: +86-18613190779 - > Fax: +86-755-62809168 - > Contact Person(Title): Salon Chen (System engineer) - > E-mail: 33999439@qq.com #### 6. Device Description Disposable Medical Surgical Face Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Surgical Face Mask is sold non-sterile and is intended to be a single use, disposable device. ### 7. Indications for Use Statement Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids. #### Comparison to the Predicate Device 8. {5}------------------------------------------------ | Elements of Comparison | Proposed Device | Predicate Device | Judgment | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Company Name | Guangdong Haiou Medical<br>Apparatus Co., Ltd.. | PFM Medical, Inc. | / | | Device Name | Disposable Medical<br>Surgical Face Mask | ASEPT® Surgical Face Mask | / | | 510(k) Number | K203200 | K201137 | / | | Classification Product Code | FXX | FXX | Same | | Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Classification Name | Surgical Apparel | Surgical Apparel | Same | | Class | 2 | 2 | Same | | Prescription or OTC | OTC | OTC | Same | | Intended Use & Indications for Use | Disposable Medical<br>Surgical Face Mask is<br>indicated as a protective<br>nose and mouth covering<br>for healthcare workers and<br>patients involved in<br>medical and surgical<br>procedures. The masks<br>are indicated in any<br>procedure or situation<br>where there is a risk of<br>exposure to<br>microorganisms and body<br>fluids. | The ASEPT® Surgical<br>Face Mask is indicated as<br>a protective nose and<br>mouth covering for<br>healthcare workers and<br>patients involved in<br>medical and surgical<br>procedures. The masks<br>are indicated in any<br>procedure or situation<br>where there is a risk of<br>exposure to<br>microorganisms and body<br>fluids. | Same | {6}------------------------------------------------ | | | Inner and Outer<br>Layers | Spun-bond polypropylene | Spun-bond polypropylene | | |-------------------------------------------------|------------------------------------|---------------------------|------------------------------------------------------------|------------------------------------------------------------|----------------| | Materials | Middle Layer | | Melt blown polypropylene<br>filter | Melt blown polypropylene<br>filter | Same | | | Ear Loops | | Polyester | Polyester | | | | Nose Piece | | Malleable polyethylene<br>with aluminum wire | Malleable polyethylene<br>with aluminum wire | | | | | | | | | | Dimension | | | 17.5cm length x 9.5cm<br>height | 17.5cm length x 9.5cm<br>height | Same | | Mask Style | | | Pleated | Pleated | Same | | Design Features | | | Malleable nosepiece, flat<br>pleated,<br>elastic ear loops | Malleable nosepiece, flat<br>pleated,<br>elastic ear loops | Same | | Sterility | | | Non-sterile | Non-sterile | Same | | Use | | | Single Use,Disposable | Single Use,Disposable | Same | | Color | | | Blue and White | Blue and White | Same | | ASTM F2100 level | | | Level 3 | Level 2 | Different<br>1 | | Resistance to Penetration by<br>Synthetic Blood | | | Level 3: 160 mm Hg | Level 2: 120 mm Hg | | | Differential Pressure | | | Level 3: < 6.0 | Level 2: <6.0 | Same | | Flammability | | | Class 1 | Class 1 | Same | | Bacterial Filtration Efficiency<br>(BFE) | | | Level 3: ≥ 98 | Level 2: ≥ 98 | Same | | Sub-Micron Particulate Filtration | | | Level 3: ≥ 98 | Level 2: ≥ 98 | Same | | Biocompatibility | Cytotoxicity,ISO<br>10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Same | | | | Irritation,ISO<br>10993-10:2002 | Non-irritating | Non-irritating | | | | | Sensitization,ISO<br>10993010:2002 | Non-sensitizing | Non-sensitizing | | | {7}------------------------------------------------ ### Analysis: Different 1:According to ASTM F2100 standard and test result, Haiou's Disposable Medical Surgical Face Mask ratings is level 3, the level 3 performance is the better than the level 2 performance in ASTM F2100 standard,thus,Haiou's Disposable Medical Surgical Face Mask is safe. ## 9. Non-Clinical Test Conclusion ### Non-clinical data: Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device: | Item | Standard | Acceptance Criteria | Results | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------| | Fluid Resistance<br>Performance | ASTM F1862:<br>Standard Test Method<br>for Resistance of<br>Medical Face Masks to<br>Penetration by<br>Synthetic Blood | Level 3:160 mm Hg | All samples met the<br>predetermined<br>acceptance criteria. | | Bacterial Filtration<br>Efficiency | ASTM F2100-19:<br>Standard Specification<br>for Performance of<br>Materials Used in<br>Medical Face Masks | $\ge$ 98% | All samples met the<br>predetermined<br>acceptance criteria. | | Differential Pressure | ASTM F2100-19: | < 6.0 mm H2 O/cm2 | All samples met the | | | | | | | (Delta P) | Standard Specification | | predetermined | | | for Performance of | | acceptance criteria. | | | Materials Used in | | | | | Medical Face Masks | | | | | ASTM F2100-19: | | All samples met the | | Particulate Filtration | Standard Specification | > 98% | predetermined | | Efficiency | for Performance of | | acceptance criteria. | | | Materials Used in | | | | | Medical Face Masks | | | | | | | All samples met the | | Flammability | 21 CFR 1610 | Class I, Does not Ignite | predetermined | | | | | acceptance criteria. | | | | | | | | | | | | | ISO 10993-5: | | | | | Biological evaluation | | All samples met the | | Cytotoxicity | of medical devices | Non-cytotoxic | predetermined | | | — Part 5: Tests | | acceptance criteria. | | | for in vitro | | | | | cytotoxicity | | | | | | | | | | ISO 10993-10: | | All samples met the | | Irritation | Biological | Non-irritating | | | | evaluation of medical | | predetermined | | | | | acceptance criteria. | | | devices — | | | | | Part 10: Tests for | | | | | irritation and<br>skin sensitization | | | | Sensitization | ISO 10993-10:<br>Biological<br>evaluation of medical devices —<br>Part 10: Tests for<br>irritation and<br>skin sensitization | Non-sensitizing | All samples met the<br>predetermined<br>acceptance criteria. | {8}------------------------------------------------ {9}------------------------------------------------ # 10. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) Disposable Medical Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201137.