Medical Surgical Mask-Model MP002-5, MP002-6
Device Facts
| Record ID | K202577 |
|---|---|
| Device Name | Medical Surgical Mask-Model MP002-5, MP002-6 |
| Applicant | Jiangmen Sure&Me Medical Product Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jan 11, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
Device Story
Medical Surgical Mask (Models MP002-5, MP002-6) is a flat-style, single-use, disposable face mask. Device consists of three layers: inner and outer polypropylene layers and a middle polypropylene melt-blown layer. Features include a plastic nose clip for facial fit and either high-elastic spandex ear loops (MP002-6) or tie-on bands (MP002-5). Device is worn over the mouth and nose to provide a physical barrier against microorganisms, body fluids, and particulates. Used in healthcare settings or by the general public for infection control. Healthcare providers or patients wear the device to reduce cross-contamination risk. Performance meets ASTM F2100 Level 3 standards, including fluid resistance at 160 mmHg, bacterial filtration efficiency >99.9%, and particulate filtration efficiency ≥98%.
Clinical Evidence
No clinical data. Bench testing only. Performance validated per ASTM F2100-19, including Bacterial Filtration Efficiency (>99.9%), Differential Pressure (<6.0 mm H2O/cm²), Sub-micron Particulate Filtration Efficiency (≥98% at 0.1 µm), and Synthetic Blood Penetration Resistance (160 mmHg). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).
Technological Characteristics
Three-layer construction: polypropylene inner/outer layers, polypropylene melt-blown middle layer. Plastic nose clip. Spandex ear loops or tie-on bands. Non-sterile, single-use. Dimensions: 17.5cm x 9.5cm. Performance: ASTM F2100 Level 3. Biocompatibility: ISO 10993-5, ISO 10993-10. Flammability: 16 CFR Part 1610 Class 1.
Indications for Use
Indicated for infection control in the health care industry to protect patients and wearers from transfer of microorganisms, body fluids, and particulate material. Suitable for over-the-counter use.
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
- The New Medical Mask (K093179)
Submission Summary (Full Text)
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January 11, 2021
Jiangmen Sure&Me Medical Product CO., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202577
Trade/Device Name: Medical Surgical Mask-Model MP002-5, MP002-6 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 18, 2020 Received: December 22, 2020
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Elizabeth Claverie, M.S. 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) Applying
Device Name
Medical Surgical Mask (Model: MP002-5, MP002-6)
Indications for Use (Describe)
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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 K202577
#### 1. Submitter's Information
510(k) Owner's Name: JIANGMEN SURE&ME MEDICAL PRODUCT CO., LTD,
Address: Jingshuiwan, Chakeng Village Committee, Huicheng Town, Xinhui District, Jiangmen City, Guangdong Province, China
Post Code: 529000
Contact Person: Liang Meixia
Phone: +86 18138977291
Fax: 0750-6393444
E-mail: mxliang1974@126.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
#### 2. Date of the summary prepared: 2021-01-09
#### 3. Subject Device Information
Type of 510(k): Traditional
Classification Name: Mask, Surgical
Common name: Surgical Mask
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Trade Name: Medical Surgical Mask Models: MP002-5, MP002-6 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
#### 4. Predicate Device Information
Sponsor: H&H RESEARCH COMPANY Trade Name: The New Medical Mask Classification Name: Mask, Surgical 510(K) Number: K093179 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
#### 5. Device Description
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8)
The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask.
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The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line.
The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device.
The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm*1cm±0.2cm (L*W), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm*0.4cm(L*W). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm*2.5mm* 0.45mm (L*W*H).
## 6. Intended Use / Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
## 7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | JIANGMEN SURE&ME<br>MEDICAL PRODUCT CO., LTD | H&H RESEARCH<br>COMPANY | -- |
| 510 (k) | K202577 | K093179 | -- |
| Trade Name | Medical Surgical Mask | The New Medical Mask | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Identical |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Identical |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| | | | |
| Intended use | This product is indicated for<br>infection control practices in the<br>health care industry. When worn<br>properly, The Medical Surgical<br>Mask is intended to protect both<br>patient and wearer from the<br>transfer of microorganisms, body<br>fluids and particulate material. | This product is indicated for<br>infection control practices in<br>the health care industry.<br>When worn properly, The<br>New Medical Mask is<br>intended to protect both<br>patient and wearer from the<br>transfer of microorganisms,<br>body fluids and particulate<br>material. | Identical |
| Material | | | |
| Outer facing<br>layer | Polypropylene | Polypropylene | Identical |
| Middle layer | Polypropylene melt-blown | Polypropylene | Identical<br>Note 1 |
| Inner facing<br>layer | Polypropylene | Polypropylene | Identical |
| Nose clip | Plastic environmental protection<br>line | Adhesive tape | Identical<br>Note 1 |
| Ear Loops/<br>Tie-on | Ear Loops/ Tie-on:<br>High elastic spandex | Ear Loops: Non-latex elastic<br>ear bands | Similar<br>Note 1 |
| Design<br>features | Color: blue | Color: blue | Identical |
| Mask Style | Ear Loops (model: MP002-6)<br>and Tie-on (model: MP002-5)<br>flat style | Ear loop<br>flat style | Identical<br>Note 3 |
| Specification<br>and | 17.5cm x 9.5 cm | Length: 7.1 inches (18 cm) | Similar |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Dimension | | Width: 3.9 inches (10 cm) | Note 3 |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| Performance<br>Testing | Level 3 | Level 3 | Identical |
| Fluid<br>Resistance<br>Performance | 160 mmHg | 160 mmHg | Identical |
| Particulate<br>Filtration<br>Efficiency | ≥98% | 99.9% | Identical<br>Note 2 |
| Bacterial<br>Filtration<br>Efficiency | >99.9% | >99.9% | Identical |
| Differential<br>Pressure | <6.0 mmH2O/cm² | Pass at 2.7 mmH2O/cm² | Identical<br>Note 2 |
| Flammability | Class 1 | Class 1 | Identical |
| Latex | Not Made With Natural Rubber<br>Latex | Not Made With Natural<br>Rubber Latex | Identical |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the<br>study, the device is<br>non-cytotoxic. | Under the conditions of the<br>study, the device is<br>non-cytotoxic. | Identical |
| Irritation | Under the conditions of the<br>study, the device is<br>non-irritating. | Under the conditions of the<br>study, the device is<br>non-irritating. | Identical |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Sensitization | Under the conditions of the<br>study, the device is<br>non-sensitizing | Under the conditions of the<br>study, the device is<br>non-sensitizing | Identical |
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## Comparison in Detail(s):
## Note 1:
Although the "Middle layer", "Nose clip" and "Ear Loops" of subject device is slightly difference with predicate device, it meets the requirement standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
#### Note 2:
Although the "Particulate Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
#### Note 3:
Although the "Mask Style" and "Specification and Dimension" of subject device is little difference with predicate device, these dimensions differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
#### 8. Test Summary
Medical Surgical Mask (Models: MP002-6) has been evaluated the safety and performance by lab bench testing as following:
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
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- ASTM F1862 Standard Test Method For Resistance Of Medical Face Masks To � Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- ASTM F2101 Standard Test Method For Evaluating The Bacterial Filtration Efficiency ◆ (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus
- ASTM F2100 Standard Specification For Performance Of Materials Used In Medical • Face Masks
# 8.1 Summary of Non-Clinical Tests Performed:
| Test item | Test method | Pass criteria | Test results<br>/Verdict |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------|
| Bacterial filtration<br>efficiency | ASTM F2101-14<br>Standard Test<br>Method for<br>Evaluating the<br>Bacterial Filtration<br>Efficiency (BFE) of<br>Medical Face Mask<br>Materials, Using a<br>Biological Aerosol<br>of Staphylococcus<br>aureus according<br>to ASTM<br>F2100:2019 | ≥ 98% | >99.9% / Pass |
| Differential<br>pressure (Delta-P) | EN 14683: 2019,<br>Annex C Medical<br>face masks -<br>Requirements and<br>test methods<br>according to ASTM<br>F2100:2019 | <6.0 mm H2O/cm² | <6.0 mm H2O/cm²<br>/ Pass |
| Sub-micron<br>particulate filtration | ASTM F2299-03<br>Standard Test | ≥ 98% | ≥ 98% / Pass |
| efficiency<br>at 0.1 µm of<br>Polystyrene Latex<br>Spheres | Method for<br>Determining the<br>Initial Efficiency of<br>Materials Used in<br>Medical Face<br>Masks to<br>Penetration by<br>Particulates Using<br>Latex Spheres<br>according to ASTM<br>F2100:2019 | | |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in mm Hg<br>for pass result | ASTM<br>F1862/F1862M-17<br>Standard Test<br>Method for<br>Resistance of<br>Medical Face Masks<br>to Penetration by<br>Synthetic Blood<br>(Horizontal Projection<br>of Fixed Volume at a<br>Known Velocity)<br>according to ASTM<br>F2100:2019 | Fluid resistant<br>claimed<br>at 160 mm Hg | Fluid Resistant<br>claimed at 160 mm<br>Hg/ Pass |
| Flame spread | 16 CFR Part 1610<br>Standard for the<br>Flammability of<br>Clothing according<br>to ASTM<br>F2100:2019 | Class 1 | Class 1 / Pass |
- Performance Testing summary
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#### ● Biocompatibility Testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is B-prolonged (>24 h to 30 d). The
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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.
## 8.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
## 9. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K202577, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K093179.
