← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K212205 # Medical Protective Masks (K212205) _Qinhuangdao Taizhi Medical Technology Co., Ltd. · FXX · Oct 14, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K212205 ## Device Facts - **Applicant:** Qinhuangdao Taizhi Medical Technology Co., Ltd. - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Oct 14, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Medical Protective Masks are 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. ## Device Story Medical Protective Mask; 4-layer disposable face mask; spun-bond polypropylene inner/outer layers; melt-blown and non-woven polypropylene filter layers; PE nose piece with dual-galvanized wire; elastic ear straps. Used in clinical settings or by general public for infection control; worn over mouth and nose to provide barrier protection against blood, body fluids, and particulates. Single-use; non-sterile. Provides physical barrier to reduce exposure risk. ## Clinical Evidence No clinical data. Bench testing only. Performance verified against ASTM F2100-19 Level 2 requirements: BFE 99.9%, differential pressure 3.6-4.2 mmH2O/cm², PFE 99.63-99.84%, synthetic blood penetration resistance (32/32 passed at 120 mmHg), and Class 1 flammability. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic, non-irritating, and non-sensitizing. ## Technological Characteristics 4-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene and non-woven polypropylene (filters). PE nose piece with dual-galvanized wire. Elastic ear straps (spandex/polyester). Dimensions: 16.0cm x 11.0cm. Non-sterile. ASTM F2100-19 Level 2 compliant. ## 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 - Protective Face Mask for Medical Use ([K201537](/device/K201537.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. October 14, 2021 Qinhuangdao Taizhi Medical Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K212205 Trade/Device Name: Medical Protective Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2021 Received: July 15, 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 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. 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212205 Device Name Medical Protective Masks #### Indications for Use (Describe) Medical Protective Masks are 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 - K212205 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: Qinhuanqdao Taizhi Medical Technology Co., Ltd. Address: No.5, Small and Medium Enterprises Incubator Base, East Circular Economy Park, Haigang District, Qinhuangdao City, Hebei Province, China Phone Number: +86-13383659307 Contact: Ms. Fan Xifan Date of Preparation: 08/07/2021 #### 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 Protective Masks Common name: Surgical face mask Classification name: Mask, Surgical Style(s): Expanded chamber, Longitudinal fold, ear strap, 4 layers ### 3.0 Classification Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Surgical apparel Panel: #### 4.0 Predicate device information Manufacturer: Shandong Shengquan New Material Co., Ltd. Device: Protective Face Mask for Medical Use 510(k) number: K201537 #### 5.0 Indication for Use Statement Medical Protective Masks is intended to be worn to protect both the patient and {4}------------------------------------------------ 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color. ### 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 face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004. | Items | Performance | Acceptance Criteria
(Level 2, ASTM
F2100-19) | Result | |-------------------------------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------|--------| | Bacterial filtration
efficiency (BFE) (%) | 99.9% | ≥98 | Pass | | Different pressure
(mmH2O/cm²) | 3.6-4.2 mmH2O/cm² | <6.0 mmH2O/cm² | Pass | | Sub-micron particulate
filtration efficiency at 0.1
micron, % (PFE) | 99.63~99.84% | ≥98 | Pass | | Resistance to penetration
by synthetic blood,
Minimum pressure in
mmHg for pass result | Test 1-3: 32 of 32 test
articles passed at
120mmHg; | 29 of 32 test articles
passed at 120mmHg | Pass | | Flame spread | Class 1, Non Flammable | Class 1 | Pass | #### Table 2 - Biocompatibility Testing | Testing Items | Standards | Results | |---------------|-----------|---------| |---------------|-----------|---------| {5}------------------------------------------------ | Cytotoxicity | ISO 10993-5:2009 | Pass (Non-Cytotoxic) | |---------------|-------------------|------------------------| | Irritation | ISO 10993-10:2010 | Pass (Non-Irritating) | | Sensitization | ISO 10993-10:2010 | Pass (Non-Sensitizing) | # Table 3 Summary of Non-Clinical Performance Testing | No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results | |-----|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | ISO 10993-10:2010
Biological Evaluation Of
Medical Devices - Part
10: Tests For Irritation
And Skin Sensitization. | This part of ISO
10993 assesses
possible contact
hazards from
chemicals
released from
medical devices | Skin Sensitization
Test:
provided
grades less than 1,
otherwise
sensitization. | All grades are 0.

All animals were survived and no
abnormal signs were observed
during the study. | | 2 | | medical devices,
which may
produce skin and
mucosal irritation,
eye irritation or
skin sensitization. | Skin Irritation Test:
If the primary irritation
index is 0-0,4, the
response category is
Negligible.
0,5-1,9 means slight
2-4,9 means moderate
5-8 means severe | The primary irritation index is 0.

The response of the proposed
device was categorized as
negligible under the test
condition | | 3 | ISO 10993-5:2009
Biological Evaluation Of
Medical Devices - Part
5: Tests For In Vitro
Cytotoxicity | This part of ISO
10993 describes
test methods to
assess the in vitro
cytotoxicity of
medical devices. | The viab.% of the
100% extract of the
test article is the final
result, and if viability is
reduced to <70% of
the blank, it has
cytotoxic potential. | Viab.% of 100% test article
extract is 83.9%

It means the proposed device
have no potential toxicity to
L-929 in the MTT method | | 4 | Bacterial filtration
efficiency (BFE) (%) | The purpose of
the test is to
evaluate the
Bacterial
filtration
efficiency
(BFE) (%) | ≥98 | 99.9%
99.9%
99.9%
Pass | | 5 | Different pressure
(mmH2O/cm²) | The purpose of
the test is to
evaluate the
Different
pressure | <6.0 mmH2O/cm² | 3.8-4.2 mmH2O/cm2
3.6-4.2 mmH2O/cm2
3.7-4.1 mmH2O/cm2
Pass | | | | (mmH2O/cm²) | | | | 6 | Sub-micron
particulate filtration
efficiency at 0.1
micron, % (PFE) | The purpose of
the test is to
evaluate the
Sub-micron
particulate
filtration
efficiency at
0.1
micron, %
(PFE) | ≥98 | 99.63~99.82%
99.63~99.83%
99.63~99.84%
Pass | | 7 | Resistance to
penetration by
synthetic blood,
Minimum
pressure in
mmHg for pass
result | The purpose of
the test is to
evaluate the
Resistance to
penetration by
synthetic
blood,
Minimum
pressure in
mmHg for pass
result | 29 of 32 test
articles passed at
120mmHg | Test 1: 32 of 32 test
articles passed at
120mmHg;
Test 2: 32 of 32 test
articles passed at
120mmHg;
Test 3: 32 of 32 test
articles passed at
120mmHg Pass | | 8 | Flammability | The purpose of
the test is to
evaluate the
Flammability | Class 1 | Class 1, Non Flammable
Pass | {6}------------------------------------------------ ## 8.0 _Clinical Test Conclusion No clinical study implemented for the Medical Protective Masks. # 9.0 Technological Characteristic Comparison Table {7}------------------------------------------------ | 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 Protective Masks | Protective Face Mask for
Medical Use | - | | | 510(k) No. | K212205 | K201537 | - | | | Style(s) | Expanded chamber
Longitudinal fold, ear strap,
4 layers | Expanded chamber
flat-folded, ear loops, 4
layers | Similar | | | Intended Use | The Medical Protective
Masks 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. | The Protective Face Mask
for Medical Use is intended
to be worn to protect both
the patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material.
The face mask 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, provided non-sterile. | Same | | | OTC use | Yes | Yes | Same | | | Composite | Longitudinal fold, 4 layers | flat-folded, 4 layers | Similar | | | Material | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | | | Middle layer | Melt blown polypropylene
polypropylene non-woven
fabric | polypropylene non-woven
Melt-blown polypropylene
fabric | Same | | | External layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | | | Nose piece | PE (polyethylene) with
dual-Galvanized wire | Plastic coated aluminum
wire covered with sponge
coating | * Different 1 | | ear strap | Spandex + Polyester | Spandex + Polyester | Same | | | Color | White | White outer layer and gray inner layer | * Different 2 | | | Dimension (Length) | $16.0cm\pm0.5cm$ | $16.5\pm0.8cm$ | * Different 3 | | | Dimension (Width) | $11.0cm\pm0.5cm$ | $10.5\pm0.5cm$ | * Different 4 | | | Sterility | Non-Sterile | Non-Sterile | Same | | | Single Use | Yes | Yes | Same | | | Sterile | No | No | Same | | | ASTM F2100 Level | Level 2 | Level 2 | Same | | #### General Comparison Table 3 {8}------------------------------------------------ * Different analysis: Different 1-2: the two devices have some difference in materials and product color, product materials safety is proved by its biocompatibility, 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. #### 10.0 Conclusion The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K212205](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K212205) **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