← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K211454
# Surgical mask (K211454)
_Jiangsu Xingtong Biotechnology Group Co., Ltd. · FXX · Aug 18, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211454
## Device Facts
- **Applicant:** Jiangsu Xingtong Biotechnology Group Co., Ltd.
- **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md)
- **Decision Date:** Aug 18, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Intended Use
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from 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, and provided as sterile.
## Device Story
Surgical mask; single-use, disposable, sterile device. Composed of three layers: inner/outer polypropylene, middle melt-blown polypropylene filter. Features nose piece (polyethylene-coated steel wire) and ear loops (polyester/polyurethane) or ties (polypropylene). Used in clinical settings by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Device acts as physical barrier; no electronic or software components. Performance validated via fluid resistance, bacterial/particulate filtration efficiency, and flammability testing.
## Clinical Evidence
No clinical data. Bench testing only. Performance validated against ASTM F2100-19, including fluid resistance (160 mmHg), bacterial filtration efficiency (≥98%), particulate filtration efficiency (≥98%), differential pressure (<6.0 mm H2O/cm²), and flammability (Class I). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
## Technological Characteristics
Three-layer construction: polypropylene inner/outer layers, melt-blown polypropylene filter. Nose piece: polyethylene-coated steel wire. Ear loops: polyester/polyurethane; Ties: polypropylene. Sterile (EO gas, SAL 10^-6). Complies with ASTM F2100-19, ASTM F1862, ASTM F2101, ASTM F2299, 16 CFR 1610, ISO 10993-5/10, ISO 11135, ISO 11737-1, ISO 10993-7, ASTM F88, and ASTM F1929.
## 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
- Surgical face mask (Ear loops and Tie-on) ([K160269](/device/K160269.md))
## Submission Summary (Full Text)
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August 18, 2021
Jiangsu Xingtong Biotechnology Group Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K211454
Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021
Dear James Tsai:
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.
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
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# Indications for Use
510(k) Number (if known) K211454
Device Name Surgical mask
Indications for Use (Describe)
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from 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, and provided as sterile.
Level 3 Surgical mask model (Ear-loop): XT10A1 Level 3 Surgical mask model (Tie-on): XT10B1
| 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)
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# 510(k) Summary
#### K211454
### 1. Administrative Information
| Date of Summary prepared | August 5, 2021 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer information | Company: Jiangsu Xingtong Biotechnology Group
Co., Ltd. |
| | Company address:
No.8, Kele road, Touqiao Area, Beizhou Industrial
Park, Guangling Zone, Yangzhou City, China
Contact person: Li Hua
Tel: +86-0514-87485222 |
| | Fax: +86-0514-87481010 |
| | E-mail: 920740335@qq.com |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.
Address: 1713A, 17th Floor, Block A, Zhongguan
Times Square, Nanshan District, Shenzhen
Contact person: James Tsai
E-Mail: james tsai@cefda.com; field@cefda.com |
# 2. Device Information
| Type of 510(k) submission: | Traditional |
|----------------------------|-------------------------------------|
| Trade Name: | Surgical mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Common name | Surgical mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
# 3. Predicate Device Information
| Sponsor: | SAN-M PACKAGE CO., LTD. |
|--------------------|-------------------------------------------|
| Device trade name: | Surgical face mask (Ear loops and Tie-on) |
| Device Class: | II |
| 510(K) Number: | K160269 |
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| Regulation name | Masks, Surgical |
|------------------------|------------------------------------|
| Production regulation: | 21 CFR §878.4040 |
| Product code: | FXX |
| Review Panel: | General and plastic surgery device |
### 4. Device Descriptions
The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.
The size specification of the surgical mask:
- Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
- Mask body for Tie-on type: 17.5cm×9.5cm
### 5. Indications for Use
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from 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, provided as sterile.
# 6. Technological Characteristics Comparison
| Comparison
item | Proposed Device
(Jiangsu Xingtong
Biotechnology Group Co.,
Ltd.) | Predicate Device
(K160269, SAN-M
PACKAGE CO., LTD.) | Remark |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Surgical mask | Surgical face mask | Similar |
| Product model | Ear loops: XT10A1;
Tie-on: XT10B1 | Ear loops: EL 30000;
Tie-on: TO 30000 | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR
878.4040) | Class II (21 CFR
878.4040) | Same |
| Intended
use &
Indications for
Use | The surgical masks are
intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body
fluids. and particulate | The surgical face masks
are intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body
fluids. and particulate | Similar |
| | | | |
| | 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, provided as sterile. | 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, provided non-
sterile. | |
| Mask features | Ear Loops and Tie-on;
Flat Pleated | Ear Loops and Tie-on;
Flat Pleated | Same |
| Layers | 3 layers | 4 layers | Different |
| Outer layer | Polypropylene | Polypropylene | Same |
| Filter media | Melt-blown cloth
(polypropylene) | Polypropylene spunbond
Polypropylene meltblown | Different |
| Inner layer | Polypropylene | Polypropylene | Same |
| Ear loops | -Ear loops: Polyester silk &
Polyurethane filament
-Ties: Polypropylene | -Ear loops: Polyester,
polyurethane
-Side tapes: Polyester
spunbond (ear loops mask
only)
-Tie tapes: Polypropylene
spunbond or polyester
spunbond | Similar |
| Nose piece | Polyethylene coated
steel wire | Polyethylene coated
steel wire | Same |
| Color | Blue | White or Blue | Similar |
| Dimension | Mask body for ear-loop
type: 17.5cm×9.5cm &
14.5cm×9.5cm
Mask body for Tie-on type:
17.5cm×9.5cm | Mask body for both ear-
loop and tie-on types:
17.5cm×9.0cm &
18.0cm×9.0cm | Different |
| OTC Use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Packaging
material | Paper plastic bag | Not publicly available | Different |
| Sterilization
method and
S.A.L. | Sterilized by ethylene
oxide gas, SAL= $10-6$ | Not applied | Different |
| Shelf life | 2 years | No shelf life claim | Different |
| Use | Single-use, disposable | Single-use, disposable | Same |
| Performance | Level 3 | Level 3 | Same |
| | | | |
| level | | | |
| Fluid
Resistance
Performance | 32 Out of 32 pass at
160mmHg
(ASTM F1862) | 32 Out of 32 pass at
160mmHg
(ASTM F1862) | Same |
| Particulate
Filtration
Efficiency | Pass at ≥ 98%
(ASTM F2299) | Pass at ≥ 98%
(ASTM F2299) | Same |
| Bacterial
Filtration
Efficiency | Pass at ≥ 98%
(ASTM F2101) | Pass at ≥ 98%
(ASTM F2101) | Same |
| Differential
Pressure
(Delta-P) | Pass at <6mm H2O/cm²
(EN 14683:2019) | Pass at <5mm H2O/cm²
(MIL-M36945C) | Different |
| Flammability | Pass at Class I
(16 CFR 1610) | Pass at Class I
(16 CFR 1610) | Same |
| Cytotoxicity
ISO 10993-5 | Under the conditions of the
study, the subject device
was non-cytotoxic | Under the conditions of the
study, the subject device
was non-cytotoxic | Same |
| Sensitization
ISO 10993-10 | Under the conditions of the
study, the subject device
was non-sensitizing | Under the conditions of the
study, the subject device
was non-sensitizing | Same |
| Irritation
ISO 10993-10 | Under the conditions of the
study, the subject device
was non-irritating | Under the conditions of the
study, the subject device
was non-irritating | Same |
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Both of the proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new safe and effective issue.
From the comparison table and the gaps analysis above, the differences in the materials, layers, sizes, sterility status and packaging material will not raise any new issue for safety and effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices; EO sterilization validation has also been provided to prove the product sterility and performance; Accelerated aging test validates the shelf life of the proposed device.
In summary, the performance and biocompatibility testing of the subject device meet all the requirements of standards of ASTM F2100 and ISO 10993-5 &-10. So, the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.
#### 7. Summary of Non-clinical Testing
The following performance data of proposed device was provided in support of the substantial equivalence determination:
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# Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops or tie-on are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:
- · Cytotoxicity
- · Skin Sensitization
- Skin Irritation
# Physical performance testing
Physical performance was conducted, and the results show that the proposed device complies with the following standards:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
# Ethylene oxide Sterilization Validation
The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards:
- · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- · ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ASTM F88-2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
- · ASTM F1929-2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
# Summary
Based on the non-clinical performance data as documented above in the device development, the proposed device has a safety and effectiveness profile that is similar to the predicate device, the testing results are summarized in the following table:
| Name of Test
Methodology
(standard) | Purpose | Acceptance
Criteria | Results |
|-------------------------------------------|------------------|------------------------|-------------------------|
| ASTM F | Fluid Resistance | 29 out of 32 | Lot 1# pass at 160mmHg; |
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| 1862-17 | Performance | pass at
160 mmHg | Lot 2# pass at 160mmHg;
Lot 3# pass at 160mmHg |
|---------------------|-----------------------------------------------------|---------------------|---------------------------------------------------------------------------------|
| ASTM
F2101-19 | Bacterial Filtration
Efficiency
Performance | ≥ 98% | Lot 1# 99.7%-99.9%;
Lot 2# 99.7%-99.9%;
Lot 3# 99.7%-99.9% |
| EN 14683:
2019 | Differential
Pressure (Delta-P) | < 6.0mm
H2O/cm² | Lot 1# 2.3-4.6;
Lot 2# 2.3-4.5;
Lot 3# 2.0-3.9 |
| ASTM
F2299-2007 | Particulate
Filtration Efficiency
Performance | ≥ 98% | Lot 1# 99.2%-99.8%;
Lot 2# 99.0%-99.7%;
Lot 3# 99.3%-99.7% |
| 16 CFR Part
1610 | Flammability | Class I | Lot 1# Class I;
Lot 2# Class I;
Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the
study, the subject device was
non-cytotoxic |
| ISO 10993-
10 | Sensitization | Non-
sensitizing | Under the conditions of the
study, the subject device was
non-sensitizing |
| ISO 10993-
10 | Irritation | Non-irritating | Under the conditions of the
study, the subject device was
non-irritating |
# 8. Brief discussion of clinical tests
No clinical tests were performed.
# 9. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211454](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211454)
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