(57 days)
The Medical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Average Result) | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 120 mmHg for Level 2 | Level 2: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested) | PASS |
| (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | Level 3: 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested) | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Level 2: 99.2% (3 non-consecutive lots tested) | PASS |
| (ASTM F2299) | Level 3: 99.5% (3 non-consecutive lots tested) | PASS | |
| Bacterial Filtration Efficiency | ≥ 98% | Level 2: 99.3% (3 non-consecutive lots tested) | PASS |
| (ASTM F2101) | Level 3: 99.3% (3 non-consecutive lots tested) | PASS | |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Level 2: 5.0 mmH2O/cm² (3 non-consecutive lots tested) | PASS |
| (EN 14683 Annex C) | Level 3: 4.4 mmH2O/cm² (3 non-consecutive lots tested) | PASS | |
| Flammability | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested) | PASS |
| (16 CFR 1610) | Level 3: Class 1 (3 non-consecutive lots tested) | PASS | |
| Biocompatibility - Cytotoxicity | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance Performance (ASTM F1862): 32 samples per lot, tested across 3 non-consecutive lots.
- Particulate Filtration Efficiency (ASTM F2299): 32 samples per lot, tested across 3 non-consecutive lots.
- Bacterial Filtration Efficiency (ASTM F2101): 32 samples per lot, tested across 3 non-consecutive lots.
- Differential Pressure (EN 14683 Annex C): 32 samples per lot, tested across 3 non-consecutive lots.
- Flammability (16 CFR 1610): 32 samples per lot, tested across 3 non-consecutive lots.
- Biocompatibility (ISO 10993-5, ISO 10993-10): The document does not specify the exact sample size for biocompatibility testing, but it was conducted on the mask materials (nose clip and ear loops components were specifically mentioned).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating they were "non-clinical tests conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The tests performed are objective performance tests on the medical device itself (face mask), not assessments requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are objective laboratory performance tests with defined pass/fail criteria, not subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This medical device is a face mask, and the submission focuses on its physical and biological performance characteristics, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a medical face mask, not an algorithm or software. All performance tests are on the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established scientific and regulatory standards (e.g., ASTM F2100-19, EN 14683, ISO 10993). Compliance is determined by objective measurements against these standards.
8. The sample size for the training set:
- This information is not applicable. This is a medical face mask, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons mentioned above.
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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.
June 28, 2022
Shandong Xingyu Gloves Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K221272
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 2, 2022 Received: May 2, 2022
Dear Jarvis Wu:
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.
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
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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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 K221272 See PRA Statement below. Page 1 of 1
Submission Number (if known)
Device Name
Medical Face Mask
Indications for Use (Describe)
The Medical Face Mask is 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 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)
( 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."
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Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China
510(k) Summary K221272
K221272 Page 1 of 7
Document Date Prepared:2022/6/27
A. Applicant:
Name: Shandong Xingyu Gloves Co., Ltd.
Address: No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China
Contact Person: Carrie Li Tel: 0086-18263618867 Mail: carrie@xingyugloves.com
Submission Correspondent:
Primary contact: Mr. Jarvis Wu
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang(@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@@gmail.com
B. Device:
Proprietary Name: Medical Face Mask Common Name: Surgical Face Mask Model(s): M001, M2002, M3001, M3002
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040
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Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomic Development Zone, Weifang City, Shandong Province, China
Review Panel: Surgical Apparel
K221272 Page 2 of 7
C. Predicate device:
| 510K | Device name | ASTM F2100-19level | Manufacturer |
|---|---|---|---|
| K211631 | Surgical Face Mask | Level 2 & 3 | Macheng thimble TechnologyInvestment Co., Ltd |
(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Indications use of the device:
The Medical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19.
Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002;
Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002;
The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Shandong Xingyu Gloves Co.,Ltd. | Macheng thimbleTechnology InvestmentCo., Ltd | - | |
| 510K number | K221272 | K211631 | - | |
| Device name | Medical Face Mask | Surgical Face Mask | - | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Indications for use | The Medical Face Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This asingle use, disposable device(s),provided non-sterile. | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These face masks are intendedfor use in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This a singleuse, disposabledevice(s), provided non-sterile. | Same | |
| Material | Outerlayer | Non-woven fabric | Spun-bond polypropylene | Same |
| Middlelayer | Melt-blown Non-woven fabric | Melt blown polypropylene filter | Same | |
| Inner layer | Non-woven fabric | Spun-bond polypropylene | Same | |
| Nose clip | Metal Core Plastic(Iron wire & Polypropylene) | Malleable aluminum wire | substantiallyequivalent | |
| Ear loops | Polyester and Spandex | Polyester | substantiallyequivalent | |
| Color | Blue, Black | Blue | substantiallyequivalent | |
| Dimension | 17.5cm+/-0.5cm | substantiallyequivalent | ||
| (length) | 175mm+/-5mm | Same | ||
| Dimension(Width) | 95mm+/-5mm | 9.5cm+/-0.5cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100-19level | Level 2 & 3 | Level 2 & 3 | Same | |
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
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K221272 Shandong Xingyu Gloves Co., Ltd. Page 4 of 7 No. 2189 Yaoqian Road, Gaomic Development Zone, Weifang City, Shandong Province, China
From the comparison we found the material of proposed device's nose clip and Ear loops, as well as its color, are different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-10. There is no new risk generated from the difference of the material.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
-
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);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of > Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand test method for determining the initial efficiency of materials used in
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Shandong Xingyu Gloves Co., Ltd. No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China
medical face masks to penetration by particulates using latex spheres;
K221272 Page 5 of 7
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
Table 2 - Performance Testing
| Item | Proposed device | AcceptanceCriteria | Result | |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | Assess theperformance of amask to resistanceto a syntheticblood preparationtargeted towardthe mask at a setpressure | 32 out of 32 perlot pass at 120mmHg for 3non-consecutivelots tested;32 out of 32 perlot pass at 160mmHg for 3non-consecutivelots tested; | 29 out of 32 pass at120 mmHg forLevel 229 out of 32 pass at160 mmHg forLevel 3 | PASS |
| ParticulateFiltrationEfficiency ASTMF2299 | Assess theperformance ofa mask topenetration bysub-micronpolystyrenelatex particles of0.1 micron | 3 non-consecutivelots tested, using asample size of32/lot.Average Result-Level 2 : 99.2%Level 3 : 99.5% | ≥ 98% | PASS |
| BacterialFiltrationEfficiency ASTMF2101 | Assess theperformance ofa mask topenetration by aprepared solutionwith knownconcentration ofan indicatorbacterialorganism | 3 non-consecutivelots tested, using asample size of32/lot.Average Result-Level 2 : 99.3%Level 3 : 99.3% | ≥ 98% | PASS |
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Shandong Xingyu Gloves Co., Ltd.
K221272 No. 2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City, Shandong Province, China
| Page 6 of 7 |
|---|
| DifferentialPressure (Delta P)EN 14683 AnnexC | Assess theperformance ofa mask forresistance toair movementthrough thematerials of theface of the mask | 3 non-consecutivelots tested, using asample size of32/lot.Average Result-Level 2 : 5.0mmH2O/cm²Level 3 : 4.4mmH2O/cm² | < 6.0mmH2O/cm² | PASS |
|---|---|---|---|---|
| Flammability 16CFR 1610 | Assess theresistance of amask to ignition | 3 non-consecutivelots tested, using asample size of32/lot.Average Result-Level 2 : Class 1Level 3 : Class 1 | Class 1 | PASS |
Table 3 – Biocompatibility Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASSUnder the conditions of thestudy, the device is non-cytotoxic. |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASSUnder the conditions of thestudy, the device is non-irritating. |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASSUnder the conditions of thestudy, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission,
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the Medical Face Mask (Model: M001, M2002, M3001, M3002) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211631.
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.