← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K201622 # Medical surgical mask (K201622) _Guangdong Kingfa Sci. & Tech.Co., Ltd. · FXX · Nov 24, 2020 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201622 ## Device Facts - **Applicant:** Guangdong Kingfa Sci. & Tech.Co., Ltd. - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Nov 24, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile. ## Device Story Flat-pleated surgical mask (Model: KF-B P05) designed for healthcare worker use; protects against microorganisms, bodily fluids, and particulates. Three-layer construction: outer/inner layers of spun-bond polypropylene; middle layer of melt-blown polypropylene. Features metallic iron wire nose piece (polypropylene resin coated) and polyester/spandex elastic ear loops. Worn over mouth and nose; secured via ear loops. Non-sterile, single-use, disposable. Provides barrier protection during clinical procedures. ## Clinical Evidence No clinical data. Bench testing only. Performance verified per ASTM F2100-19: Bacterial Filtration Efficiency (99.2%), Sub-micron Particulate Filtration Efficiency (99.46%), Differential Pressure (<5.0 mm H2O/cm²), Fluid Resistance (80 mmHg), and Flammability (Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10 (cytotoxicity, irritation, sensitization). ## Technological Characteristics Three-layer mask: spun-bond polypropylene (outer/inner), melt-blown polypropylene (middle). Nose piece: metallic iron wire with polypropylene resin coating. Ear loops: polyester/spandex elastic. Dimensions: 175x95 mm. Non-sterile. ASTM F2100 Level 1 performance. Biocompatible per ISO 10993. ## 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 - Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) ([K153409](/device/K153409.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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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 24, 2020 Guangdong KINGFA Sci.&Tech.Co.,Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China Re: K201622 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, 2020 Received: October 22, 2020 Dear Cassie Lee: 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 CAPT Elizabeth Claverie Assistant Director DHT4B: Division of Health Technology 4B 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) K201622 Device Name Medical surgical mask (Model: KF-B P05) Indications for Use (Describe) Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters This device is single use and provided non-sterile. 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}------------------------------------------------ Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary # 510(k) Summary for K201622 #### 1. Submitter's Information 510(k) Owner's Name: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Address: 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China Post Code: 511500 Contact Person: Yu Xiaoge Tel: +86 2632 8999 Fax: +0763-3203108 Email: yuxiaoge@kingfa.com.cn #### Application Correspondent: Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com ## 2. Date of the summary prepared: June 10, 2020 Revision date: November 24, 2020 #### 3. Subject Device Information Type of 510(k): Traditional Classification Name: Mask, Surgical {4}------------------------------------------------ Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary Common name: Surgical Mask 510(K) Number: K201622 Trade Name: Medical surgical mask Model Name: KF-B P05 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulatory Class: 2 #### 4. Predicate Device Information Sponsor: Protect U Guard, LLC Trade Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K153409 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulation Class: 2 #### 5. Device Description The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. {5}------------------------------------------------ | Sponsor: | Guangdong KINGFA SCI.&TECH.Co.,Ltd. | |-----------------|-----------------------------------------| | Subject Device: | Medical surgical mask (Model: KF-B P05) | | Document Name: | 510(k) summary | Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. ### 6. Intended Use / Indications for Use Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile. #### 7. Comparison to predicate device and conclusion The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. | Elements of
Comparison | Subject Device | Predicate Device | Verdict | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Company | Guangdong KINGFA
SCI.&TECH.Co.,Ltd. | Protect U Guard, LLC | -- | | 510 (k) | K201622 | K153409 | -- | | Trade Name | Medical surgical mask | Protect U Guard Earloop and
Tie-On Mask (Blue, White or | -- | | Elements of
Comparison | Subject Device | Predicate Device | Verdict | | | | Green) | | | Classification
Name | Mask, Surgical | Mask, Surgical | Identical | | Classification | Class II Device, FXX (21
CFR878.4040) | Class II Device, FXX (21
CFR878.4040) | Identical | | Intended use/
Indications
for Use | Medical surgical mask is
intended for use by healthcare
workers during procedures to
protect both patients and
healthcare workers against
transfer of microorganisms,
bodily fluids, and particulate
matters. This device is single
use and provided non-sterile. | Earloop Mask and Tie-On Mask
is intended for use by healthcare
workers during procedures to
protect both patients and
healthcare workers against
transfer of microorganisms,
bodily fluids, and airborne
particles. This device is
single use and provided
non-sterile. | Identical | | Material | | | | | Outer facing
layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical | | Middle layer | Melt blown polypropylene | Melt blown polypropylene | Identical | | Inner facing
layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical | | Nose piece | Polypropylene and metallic iron | Aluminum strip | Similar
Note 1 | | Ear loops | Polyester and spandex elastic
band | Urethane elastic fiber | Similar
Note 1 | | Design
features | Color: blue | Color: Blue, White and Green | Similar
Note 1 | | Elements of
Comparison | Subject Device | Predicate Device | Verdict | | Mask Style | Earloop
Flat Pleated | Earloop or Tie-On
Flat Pleated | Identical | | Specification
and
Dimension | 9.5cm x 17.5 cm | 9.5cm x 17.7 cm | Identical | | OTC use | Yes | Yes | Identical | | Sterility | Non-Sterile | Non-Sterile | Identical | | Use | Single Use, Disposable | Single Use, Disposable | Identical | | Performance
Testing
(according to
ASTM-2100:
2019) | Level 1 | Level 1 | Identical | | Fluid
Resistance
Performance | Pass at 80 mmHg | Pass at 80 mmHg | Identical | | Particulate
Filtration
Efficiency | 99.46% | 99.18% | Similar
better
Note 2 | | Bacterial
Filtration
Efficiency | 99.2% | 99.17% | Similar
better
Note 2 | | Differential
Pressure | <5.0 mm H2O/cm² | 3.79 mmH2O/cm² | Similar
Note 2 | | Flammability | Class 1 | Class 1 | Identical | | Latex | Not Made With Natural Rubber
Latex | Not Made With Natural Rubber
Latex | Identical | | Elements of
Comparison | Subject Device | Predicate Device | Verdict | | Biocompatibility | | | | | Cytotoxicity | Under the conditions of the
study, the subject device extract
was determined to be
non-cytotoxic. | Under the conditions of the
study, the subject device extract
was determined to be
non-cytotoxic. | Identical | | Irritation | Under the conditions of the
study, the subject device
non-polar and polar extracts
were determined to be
non-irritating. | Under the conditions of the
study, the subject device
non-polar and polar extracts
were determined to be
non-irritating. | Identical | | Sensitization | Under the conditions of the
study, the subject device
non-polar and polar extracts
were determined to be
non-sensitizing. | Under the conditions of the
study, the subject device
non-polar and polar extracts
were determined to be
non-sensitizing. | Identical | {6}------------------------------------------------ Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary Sponsor: {7}------------------------------------------------ Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary {8}------------------------------------------------ Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary ## Comparison in Detail(s): #### Note 1: Although the "Design features", "Nose piece" and "Ear loops" of subject device is little difference with predicate device, it meet the requirement standard ISO 10993 . The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. ## Note 2: Although the "Fluid Resistance Performance", "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency", "Differential Pressure" and "Specification and Dimension" of subject device is little difference with predicate device, it meet the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. {9}------------------------------------------------ # 8. Summary of Non-Clinical Tests Performed: - Performance Testing summary | Test item
(Performance
Level 1) | Test method | Pass criteria | Test results
/Verdict | |--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------| | Bacterial filtration
efficiency | ASTM F2101-14
Standard Test
Method for
Evaluating the
Bacterial Filtration
Efficiency (BFE) of
Medical Face Mask
Materials, Using a
Biological Aerosol
of Staphylococcus
aureus according
to ASTM
F2100:2019 | ≥ 95% | 99.2% / Pass | | Differential
pressure (Delta-P) | EN 14683: 2019,
Annex C Medical
face masks -
Requirements and
test methods
according to ASTM
F2100:2019 | <5.0 mm H2O/cm² | <5.0 mm H2O/cm²
/ Pass | | Sub-micron
particulate filtration
efficiency
at 0.1 µm of
Polystyrene Latex
Spheres | ASTM F2299-03
Standard Test
Method for
Determining the
Initial Efficiency of
Materials Used in
Medical Face
Masks to
Penetration by | ≥ 95% | 99.46% / Pass | | | Particulates Using
Latex Spheres
according to ASTM
F2100:2019 | | | | Resistance to
penetration by
synthetic
blood, minimum
pressure in mm Hg
for pass result | ASTM
F1862/F1862M-17
Standard Test
Method for
Resistance of
Medical Face Masks
to Penetration by
Synthetic Blood
(Horizontal Projection
of Fixed Volume at a
Known Velocity)
according to ASTM
F2100:2019 | Fluid resistant
claimed
at 80 mm Hg | Fluid Resistant
claimed at 80 mm Hg
/ Pass | | Flame spread | 16 CFR Part 1610
Standard for the
Flammability of
Clothing according
to ASTM
F2100:2019 | Class 1 | Class 1 / Pass | {10}------------------------------------------------ Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary #### ● 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 B-prolonged (>24 h to 30 d). 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, {11}------------------------------------------------ | Sponsor: | Guangdong KINGFA SCI.&TECH.Co.,Ltd. | |-----------------|-----------------------------------------| | Subject Device: | Medical surgical mask (Model: KF-B P05) | | Document Name: | 510(k) summary | 3) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization. ### 9. Summary of Clinical Performance Test No clinical study is included in this submission. #### 10. Final Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K201622, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201622](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201622) **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