Surgical Mask-Models CR02-2, CR02
Device Facts
| Record ID | K202424 |
|---|---|
| Device Name | Surgical Mask-Models CR02-2, CR02 |
| Applicant | Foshan Xinbao Technology Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 31, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
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 masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Story
Surgical mask (models CR02-2, CR02) designed as three-layer, flat-pleated device with ear loops and nose clip; worn by healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulates. Device consists of spun-bond polypropylene outer/inner layers and meltblown polypropylene filter layer; galvanized iron nose clip; nylon/spandex ear loops. Single-use, disposable, non-sterile. Used in clinical settings for infection control. Provides physical barrier to reduce exposure to blood and body fluids; helps prevent cross-contamination between wearer and environment.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F2101 (BFE), EN 14683 (Delta-P), ASTM F2299 (PFE), ASTM F1862 (synthetic blood penetration), and 16 CFR Part 1610 (flammability). Biocompatibility confirmed per ISO 10993-1, -5, and -10 (cytotoxicity, sensitization, irritation).
Technological Characteristics
Three-layer construction: spun-bond polypropylene (outer/inner), meltblown polypropylene (filter). Galvanized iron nose clip. Nylon/spandex ear loops. Flat-pleated form factor. Non-sterile. Complies with ASTM F2100-19, ASTM F2101-14, ASTM F2299-03, ASTM F1862-17, and ISO 10993-1/5/10.
Indications for Use
Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.
Regulatory Classification
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 Masks (Ear Loops And Tie-On) (K160269)
Submission Summary (Full Text)
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March 31, 2021
Foshan Xinbao Technology 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: K202424
Trade/Device Name: Surgical Mask-Model CR02-2, CR02 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 21, 2020 Received: August 25, 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.
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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.
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K202424
Device Name Surgical Mask (Model: CR02-2, CR02)
#### 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 masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, 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)
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# 510(k) Summary for K202424
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
#### 1. Submitter's Information
510(k) Owner's Name: Foshan Xinbao Technology Co., Ltd. Establishment Registration Number: Applying Address: No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City, Guangdong, China Contact Person: Weishan Peng Email: pengweishan1120@foxmail.com
#### 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
#### Date of the summary prepared: November 26, 2020 2.
#### 3. Revision date: March 4, 2021
#### 4. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common Name: Surgical apparel Trade Name: Surgical Mask Model Name: CR02-2, CR02 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II
#### 5. Predicate Device Information
Sponsor: San-M Package Co., Ltd. Trade Name: Surgical Face Masks (Ear Loops And Tie-On) Classification Name: Mask, Surgical Common Name: Surgical apparel 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
#### 6. Device Description
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The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
### 7. 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 material. These masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
#### 8. 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<br>Comparison | Subject Device | Predicate Device | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Foshan Xinbao Technology Co., Ltd. | San-M Package Co., Ltd. | -- |
| 510 (k) | K202424 | K160269 | -- |
| Trade Name | Surgical Mask | Surgical Face Masks (Ear Loops<br>And Tie-On) | -- |
| Model | CR02-2<br>CR02 | EL 10000<br>EL 20000<br>EL 30000 | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 FR<br>78.4040) | Class II Device, FXX (21 CFR<br>78.4040) | Same |
| Intended use | The Surgical Masks are intended to<br>be worn to protect both the patient<br>and healthcare personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material.<br>These masks are intended for use in<br>infection control practices to reduce<br>potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device, provided non-<br>sterile. | The surgical face masks are<br>intended to be worn to protect both<br>the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. These<br>face masks are intended for use in<br>infection control practices to reduce<br>the potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device, provided non-<br>sterile. | Same |
| Material | | | |
| Outer facing<br>layer | Spun-bond polypropylene | Polypropylene | Same |
| Middle layer | Melt blown polypropylene | 1. Polypropylene spunbond<br>2. Polypropylene meltblown | Similar<br>Note 1 |
| Inner facing<br>layer | Spun-bond polypropylene | Polypropylene | Same |
| Nose clip | Galvanized iron wire | Polyethylene coated steel wire | Similar<br>Note 1 |
| Ear loops | Nylon and Spandex | Ear loops: Polyester,<br>polyurethane | Similar<br>Note 1 |
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| | | | Side tapes: Polyester spunbond<br>(ear loops mask only) | | | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|-------------------|
| Color | Blue | | White, Blue | | | Same |
| Mask Style | Flat Pleated | | Flat Pleated | | | Same |
| Specification<br>and Dimension | Length: 17.5cm±1cm<br>Width: 9.5cm±1cm | | Length: 90 ± 3 mm<br>Width:175 ± 5 mm | | | Similar<br>Note 1 |
| OTC use | Yes | | Yes | | | Same |
| Sterility | Non-Sterile | | Non-Sterile | | | Same |
| Use | Single Use, Disposable | | Single Use, Disposable | | | Same |
| ASTM F2100<br>Level | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| Fluid<br>Resistance<br>Performance | Pass at 120<br>mmHg | Pass at 160<br>mmHg | Pass at 80<br>mmHg | Pass at<br>120<br>mmHg | Pass at<br>160<br>mmHg | Same |
| Particulate<br>Filtration<br>Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at<br>99.6% | Pass at<br>99.6% | Pass at<br>99.7% | Similar<br>Note 2 |
| Bacterial<br>Filtration<br>Efficiency | Pass at ≥98% | Pass at ≥98% | Pass<br>at >98% | Pass<br>at >98% | Pass<br>at >99% | Similar<br>Note 2 |
| Differential<br>Pressure | Pass at <6.0<br>mm H2O/cm² | Pass at <6.0 mm<br>H2O/cm² | Pass at<br>2.0 mm<br>H2O/cm² | Pass at<br>1.6 mm<br>H2O/cm² | Pass at<br>2.5 mm<br>H2O/cm² | Similar<br>Note 2 |
| Flammability | Class 1 | | Class 1 | | | Same |
| Biocompatibility | | | | | | |
| Cytotoxicity | Under the conditions of the study,<br>the subject device extract was<br>determined to be non-cytotoxic. | | Under the conditions of the study,<br>the subject device extract was<br>determined to be non-cytotoxic. | | | Same |
| Irritation | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to be<br>non-irritating. | | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to<br>be non-irritating. | | | Same |
| Sensitization | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to be<br>non-sensitizing. | | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined to<br>be non-sensitizing. | | | Same |
#### Comparison in Detail(s): Note 1:
Although the "Middle layer", "Nose clip", "Ear loops" and "Specification and Dimension" of subject device is little difference with predicate device, it meets the requirement of essential performance 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 "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, and they all meet the requirements of essential performance standard ASTM F2100. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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# 9. Summary of Non-Clinical Performance Testing Performance Testing summary
| | | Pass criteria | Test | |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|---------------------|
| Test item | Test method | For Level<br>2 | For Level<br>3 | results<br>/Verdict |
| Bacterial<br>filtration<br>efficiency | ASTM F2101-14 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of Medical<br>Face Mask Materials, Using a<br>Biological Aerosol of Staphylococcus<br>aureus according to ASTM<br>F2100:2019 | ≥ 98% | ≥ 98% | Pass |
| Differential<br>pressure<br>(Delta-P) | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and test<br>methods according to ASTM<br>F2100:2019 | <6.0 mm<br>H2O/cm² | <6.0 mm<br>H2O/cm² | Pass |
| Sub-micron<br>particulate<br>filtration<br>efficiency at 0.1<br>um of<br>Polystyrene<br>Latex Spheres | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in Medical<br>Face Masks to Penetration by<br>Particulates Using Latex Spheres<br>according to ASTM F2100:2019 | ≥ 98% | ≥ 98% | Pass |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in mm<br>Hg for pass<br>result | ASTM F1862/F1862M-17<br>Standard Test Method for Resistance of<br>Medical Face Masks to Penetration by<br>Synthetic Blood (Horizontal Projection of<br>Fixed Volume at a Known Velocity)<br>according to ASTM F2100:2019 | Fluid<br>resistant<br>claimed<br>at 120<br>mm Hg | Fluid<br>resistant<br>claimed<br>at 160<br>mm Hg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according to<br>ASTM F2100:2019 | Class 1 | Class 1 | Pass |
## Biocompatibility Testing
According to ISO 10993-1: 2018, 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,
3) Skin Irritation Tests per ISO 10993-10: 2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
#### 10. Summary of Clinical Performance Test
No clinical study is included in this submission.
#### 11. Final Conclusion:
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The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device identified in K160269.
