← Product Code [FXX](/productcode/FXX) · K212203
# Dong Hai Xiang Surgical Mask (K212203)
_Taizhou Donghaixiang Protective Equipment Co., Ltd. · FXX · Apr 7, 2022 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K212203
## Device Facts
- **Applicant:** Taizhou Donghaixiang Protective Equipment Co., Ltd.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Apr 7, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Indications for Use
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adults only. The device is disposable and is indicated for single use. The device is not provided sterile.
## Device Story
Dong Hai Xiang Surgical Mask; 3-layer flat-pleated mask; outer/inner layers polypropylene; middle layer polypropylene melt-blown filter; spandex/nylon ear-loops; polyethylene/galvanized iron wire nosepiece. Used in healthcare settings/OTC; protects patient and personnel from body fluids, microorganisms, and particulates. Single-use, disposable, non-sterile. Provides physical barrier; performance verified via bench testing against ASTM/EN standards.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F1862 (synthetic blood penetration, 160 mmHg), ASTM F2299 (particulate filtration efficiency ≥99.96%), ASTM F2101 (bacterial filtration efficiency ≥99.9%), and EN 14683 (differential pressure ~4.0 mmH2O/cm²). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
## Technological Characteristics
3-layer flat-pleated mask. Materials: Polypropylene (outer/inner), Polypropylene melt-blown (filter), Spandex/Nylon (ear-loops), Polyethylene/Galvanized iron wire (nosepiece). Dimensions: 17.5cm x 9.5cm. Non-sterile. No software/electronics.
## 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
- Avianz® Surgical Face Mask ([K200847](/device/K200847.md))
## Submission Summary (Full Text)
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April 7, 2022
Taizhou Donghaixiang Protective Equipment Co., Ltd % Shuai Wang CEO Getilapson (Dalian) Biological Technology Co., Ltd RM. 408 NO. 207, Zhongnan Rd Dalian. 116001 China
Re: K212203
Trade/Device Name: Dong Hai Xiang Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 11, 2022 Received: March 7, 2022
Dear Shuai 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.
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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.
Clarence W. Murray, III, PhD 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
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# Indications for Use
510(k) Number (if known) K212203
Device Name Dong Hai Xiang Surgical Mask
#### Indications for Use (Describe)
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
> Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of Title 21. CFR Section 807.92. The assigned 510(k) number: K212203 Date of Preparation: 11/01/2022
### 1. Contact Information
### 1.1 Applicant
Applicant Name: Taizhou Donghaixiang Protective Equipment Co., Ltd. Address: No.3091 Dunan Road Duqiao Town, Linhai, Zhengjiang, China 317016 Contact Person: Hong Wei Title: General Manager Telephone: +86-137-58627711 Email: usfdahuamei@hotmail.com
#### 1.2 Consultant
Company: Getilapson (Dalian) Biological Technology Co., Ltd Address: RM. 408 NO. 207, Zhongnan Rd, Dalian, China, 116001 Contact Person: Shuai Wang Telephone: +1 503-559-0930 Email: usfdahuamei@hotmail.com
#### 2. Device Information
Trade Name: Dong Hai Xiang Surgical Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
### 3. Legally Marketed Primary Predicate Device
Product name: Avianz® Surgical Face Mask_ 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC.
### 4. Indication For Use
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adults only. The device is disposable and is indicated for single use. The device is not provided sterile.
#### 5. Device Description
The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter
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(Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | FXX | FXX | Same |
| Regulation | 21 C.F.R Section 878.4040 | 21 C.F.R Section 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Intended use | Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adults only. The device is disposable and is indicated for single use. The device is not provided sterile. | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face masks are 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. | Same |
| Mask Style | Flat-pleated, earloop, 3 layers | Flat-pleated, earloop, 3 layers | Same |
## 6. Technological Characteristics Comparison
### 6.1 Material Used
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device Avianz®
Surgical Face Mask
(K200847) | Comparison |
|------------------|----------------------------------------|-------------------------------------------------------------|------------|
| Inner layer | Polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene Melt-blown | Melt blown polypropylene filter | Same |
| Outer layer | Polypropylene | Spun-bond polypropylene | Same |
| Earloop | Spandex + Nylon | Polyester | Different |
| Nose piece | Polyethylene +
Galvanized Iron wire | Malleable aluminum wire | Different |
#### 6.2 Design Features
| Comparison Items | Predicate Device | Comparison |
|------------------|------------------------------|------------|
| | Dong Hai Xiang Surgical Mask | |
| | Avianz® Surgical Face Mask | |
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| | (K200847) | |
|--------------------------|----------------------------------------|------|
| Use Environment | OTC, or Healthcare or related settings | Same |
| Single-use/ Multiple-use | Single-use | Same |
| Color | Blue | Same |
# 6.3 Sterility
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|------------------------------|-------------------------------------------------------------|------------|
| Sterilization | No-Sterile | No-Sterile | Same |
### 6.4 Dimension
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|------------------------------|-------------------------------------------------------------|------------|
| Length | 17.5cm | 17.5±1cm | Different |
| Width | 9.5cm | 9.5±1cm | Different |
# 6.5 Performance
| Comparison Items | Dong Hai Xiang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------|
| Resistance to Penetration
by Synthetic blood
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) | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: 32 Out of 32 pass at 160 mmHg
Lot 2: 32 Out of 32 pass at 160 mmHg
Lot 3: 32 Out of 32 pass at 160 mmHg | ≥ 30 Out of 32 pass
at 120 mmHg | Different |
| Particulate Filtration
Efficiency ASTM
F2299/F2299M-03
(2017) Standard Test
Method for Determining
the Initial Efficiency of
Material Used in medical | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: ≥ 99.96%
Lot 2: ≥ 99.96%
Lot 3: ≥ 99.96% | ≥ 99.9% | Different |
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| Face Masks to
Penetration by
Particulates using Latex
Spheres | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------|
| Bacterial Filtration
Efficiency ASTM
F2101-2019 Standard
Test Method for
Evaluating the Bacterial
Filtration Efficiency
(BFE) of Medical Face
Mask Materials, Using a
Biological Aerosol of
Staphylococcus aureus | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: ≥ 99.9%
Lot 2: ≥ 99.9%
Lot 3: ≥ 99.9% | ≥98% | Different |
| Differential Pressure EN
14683:2019 Medical face
masks- Requirements
and test methods | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: Average 3.96 mmH20/cm²
Lot 2: Average 4.14 mmH20/cm²
Lot 3: Average 4.10 mmH20/cm²
(EN 14683:2019, Annex C and
ASTM F2100-20) | 3.0 mmH20/cm² (MILM-
36954C) | Different |
| Flammability 16 CFR
1610 Standard for the
Flammability of Clothing
Textiles Corrections | Class 1 Pass (96/96) 32 Samples
Each from 3 non-consecutive lots
Lot 1: Class 1 Pass
Lot 2: Class 1 Pass
Lot 3: Class 1 Pass | Class 1 | Same |
# 6.6 Biocompatibility
| Comparison
Items | Dong Hai Xiang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|
| In Vitro Cytotoxicity
Test
ISO 10993-5: 2009 | ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-
cytotoxic. | ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-
cytotoxic. | Same |
| Skin Irritation Test
ISO 10993-10:2010 | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-irritating. | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-irritating. | Same |
{7}------------------------------------------------
| Skin Sensitization Test
ISO 10993-10:2010 | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing. | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing. | Same |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------|
| Flammability | Class 1 | Class 1 | Same |
# 7. Nonclinical Test
Nonclinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
## 7.1 Performance Test:
A bench test was conducted on Dong Hai Xiang Surgical Mask for the proposed device to determine substantial equivalence. The bench tests include the following tests:
| Performance Test | Purpose | Acceptance Criteria | Result |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance
Performance ASTM
F1862-17 | Evaluate the resistance of
Medical Face Masks to
Penetration by Synthetic
Blood (Horizontal Projection
of Fixed Volume at a Known
Velocity) | ≥29 of 32 pass at 160 mmHg | Passed Pass (96/96) 32
Samples Each from 3 non-
consecutive lots
Lot 1: 32 Out of 32 pass
at 160 mmHg |
| | | | Lot 2: 32 Out of 32 pass
at 160 mmHg
Lot 3: 32 Out of 32 pass
at 160
mmHg |
| Particulate Filtration
Efficiency ASTM F2299-17 | Evaluate the Initial Efficiency
of Material Used in medical
Face Masks to Penetration by
Particulates using Latex
Spheres | ≥ 98% | Pass (96/96) 32 Samples
Each
from 3 non-consecutive
lots
Lot 1: ≥ 99.96%
Lot 2: ≥ 99.96%
Lot 3: ≥ 99.96% |
| Bacterial Filtration
Efficiency ASTM F2101-19 | Evaluate the Bacterial
Filtration Efficiency (BFE) of
Medical Face Mask Materials,
Using a Biological Aerosol of
Staphylococcus aureus | ≥ 98% | Pass (96/96) 32 Samples
Each from 3 non-
consecutive lots
Lot 1: ≥ 99.9%
Lot 2: ≥ 99.9%
Lot 3: ≥ 99.9% |
| Differential Pressure (Delta
P) EN 14683:2019, Annex
C and ASTM F2100-19. | Evaluate the medical Face
Masks' resistance to airflow
across the face mask
Differential pressure (Delta-
P) | <6.0 mmH20/cm² | Passed Pass (96/96) 32
Samples Each from 3 non-
consecutive lots
Lot 1: Average 3.96
mmH20/cm²
Lot 2: Average 4.14
mmH20/cm² |
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| | | | Lot 3: Average 4.10 mmH20/cm²
(EN 14683:2019, Annex C
and ASTM F2100-20) |
|--------------------------|----------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Flammability 16 CFR 1610 | Evaluate the medical Face
Masks' flammability when
exposed to a direct source of
ignition | Class 1 | Class 1 Pass
(96/96) 32 Samples
Each from 3 non-
consecutive lots
Lot 1: Class 1 Pass
Lot 2: Class 1 Pass
Lot 3: Class 1 Pass |
# 7.2 Biocompatibility Evaluation and Test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- 7.2.1 In Vitro Cytotoxicity Test (ISO 10993-5: 2009 )
- 7.2.2 Skin Irritation Test(ISO 10993-10:2010)
## 7.2.3 Skin Sensitization Test (ISO 10993-10:2010)
| Biocompatibility
Evaluation and Test | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 7.2.1
In Vitro Cytotoxicity Test
ISO 10993-5: 2009 | Evaluate under the
conditions of the study,
the proposed device
extract was determined to
be non- cytotoxic. | Non-cytotoxic. | ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-
cytotoxic. |
| 7.2.2
Skin Irritation Test
ISO 10993-10:2010 | Evaluate under the
conditions of the study,
the proposed device
extract was determined to
be non- irritating. | Non-irritating. | ISO 10993-10; Under the
conditions of the study, the
proposed device extract was
determined to be non-
irritating. |
| 7.2.3
Skin Sensitization Test
ISO 10993-10:2010 | Evaluate under the
conditions of the study, the
proposed device extract was
determined to be non-
sensitizing. | Non-sensitizing | ISO 10993-10. Under the
conditions of the study, the
proposed device extract was
determined to be non-
sensitizing. |
#### 8. Clinical Test Conclusion
No clinical study is included in this submission.
### 9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device, Dong Hai Xiang Surgical Mask, is as safe, as effective and performs as well as or better than the legally marketed device.
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**Source:** [https://fda-staging.innolitics.com/device/K212203](https://fda-staging.innolitics.com/device/K212203)
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