(129 days)
Not Found
No
The device description and performance testing focus solely on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No.
The device is intended to protect the wearer from the transfer of microorganisms, body fluids, and particulate material, not to treat a condition.
No
The device is a medical face mask intended for protection and infection control, not for diagnosing any medical condition.
No
The device description clearly outlines a physical, disposable medical face mask made of various materials (polypropylene, nylon, spandex, PE, galvanized iron wire) and includes dimensions and physical features like ear loops, tie-ons, and a nose strip. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The description clearly states the device is a "Disposable Medical Face Mask" intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Specimen Analysis: The device does not interact with or analyze any biological specimens from the patient. Its function is external and protective.
- Performance Testing: The performance testing described (filtration efficiency, pressure, blood penetration, flame spread, biocompatibility) are all related to the physical properties and safety of the mask as a barrier, not to the analysis of biological samples.
Therefore, based on the provided information, the Disposable Medical Face Mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Disposable 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm.
The models MK-34, DY 95 and DY 97, ear loops, are held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm.
The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.
The device is sold non-sterile and are intended to be single use, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Bacterial filtration efficiency: Model MK-34, DY 95 and DY 97: 99.8%; Model DY 96: 99.9%. Pass criteria: >= 98%.
Differential pressure (Delta-P): Model MK-34, DY 95 and DY 97: 4.2 mm H2O/cm^2; Model DY 96: 4.0mm H2O/cm^2. Pass criteria: = 98%.
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result: Pass at 120 mm Hg. Pass criteria: resistant claimed at 120 mm Hg.
Flame spread: Class 1. Pass criteria: Class 1.
Biocompatibility Testing:
Cytotoxicity: Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. Result: PASS.
Irritation: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. Result: PASS.
Sensitization: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. Result: PASS.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency: Model MK-34, DY 95 and DY 97: 99.8%; Model DY 96: 99.9%.
Differential pressure (Delta-P): Model MK-34, DY 95 and DY 97: 4.2 mm H2O/cm^2; Model DY 96: 4.0mm H2O/cm^2.
Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres: Model MK-34, DY 95 and DY 97: 98.9%; Model DY 96: 99.3%.
Resistance to penetration by synthetic blood: Pass at 120 mm Hg.
Flame spread: Class 1.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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April 22, 2021
Guangzhou Mei Yi Kang Medical Technology CO., LTD. % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, China, zip code 510000 Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com
Re: K203646
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 31, 2021 Received: April 5, 2021
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.
1
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 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.
For Ryan Ortega, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K203646
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
Disposable 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
Models: MK-34, DY 95, DY 96, DY 97
Type of Use (Select one or both, as applicable)
| Tenant-occupied property | |
|---|---|
| Owner-occupied property |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for K203646
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
Sponsor Name: GUANGZHOU MEI YI KANG MEDICAL TECHNOLOGY CO., LTD. Address: No.43-31 Baofeng East Road,JinShi North Avenue, Shiling Town, Huadu District, Guangzhou City, Guangdong Province, China. Post Code: 510800 Contact name: Luo Yonghui Tel: 020-22682888 E-mail: deyce988@deyce.cn
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 8200 6973 Email: regulatory@glomed-info.com
2. Date of the summary prepared: April 21, 2021
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Medical Face Mask Model Name: MK-34, DY 95, DY 96, DY 97 Review Panel: Surgical Apparel Product Code: FXX Requlation Number: 878.4040 Regulatory Class: II
4. Predicate Device Information
Predicate Device:
Sponsor: Skypro Medical Supplies Company
4
Trade Name: Skypro, SP01 Mask Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K152197 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
5. Device Description
The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm.
The models MK-34, DY 95 and DY 97, ear loops, are held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm.
The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire.
The device is sold non-sterile and are intended to be single use, disposable device.
| Model | Materials | Contact
classification | colorants | Size | Style
differences |
|-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------------------------|----------|---------------------------------------------------------------------|
| MK-34 | Outer layer:
spunbond
polypropylene,
Inner layer: melt
blown polypropylene,
Nose strip: PE and
galvanized iron wire,
Ear loops: Nylon and
Spandex | Less than
24 hours | Copper
phthalocyanine/
CAS number:
147-14-8). | 145x95mm | Ear loop style,
the ear loop is
welded on the
outer layer. |
The difference between the 4 models as below:
5
| DY 95 | Outer layer:
spunbond
polypropylene,
Inner layer: melt
blown polypropylene,
Nose strip: PE and
galvanized iron wire,
Ear loops: Nylon and
Spandex | Less than
24 hours | Copper
phthalocyanine/
CAS number:
147-14-8). | 175x95mm | Ear loop style,
the ear loop is
welded on the
outer layer. |
|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------|----------|---------------------------------------------------------------------|
| DY 96 | Outer layer:
spunbond
polypropylene,
Inner layer: melt
blown polypropylene,
Nose strip: PE and
galvanized iron wire,
Ties: Spun-bond
polypropylene | Less than
24 hours | Copper
phthalocyanine/
CAS number:
147-14-8). | 175x95mm | Tie-on style |
| DY 97 | Outer layer:
spunbond
polypropylene,
Inner layer: melt
blown polypropylene,
Nose strip: PE and
galvanized iron wire,
Ear loops: Nylon and
Spandex | Less than
24 hours | Copper
phthalocyanine/
CAS number:
147-14-8). | 175x95mm | Ear loop style,
the ear loop is
welded on the
inner layer. |
6. Intended Use / Indications for Use
Disposable 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile.
7. Comparison of Technological Characteristics
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
6
| Elements of
| Comparison | Subject Device | Predicate Device | Results |
|---|---|---|---|
| Company | GUANGZHOU MEI YI | ||
| KANG MEDICAL | |||
| TECHNOLOGY Co., Ltd. | Skypro Medical Supplies | ||
| Company | -- | ||
| 510 (k) | K203646 | K152197 | -- |
| Trade Name | Disposable Medical Face Mask | Skypro, SP01 Mask | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Same |
| Product Code | FXX | FXX | Same |
| Intended use | Disposable 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. This face | |||
| mask is intended for use in | |||
| infection control practices to | |||
| reduce the potential exposure of | |||
| the wearer to blood and body | |||
| fluids. The mask is a single use, | |||
| disposable device, provided | |||
| non-sterile. | The Skypro, SP01 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 of the wearer to | |||
| blood and body fluids. The | |||
| mask is a single use, | |||
| disposable device, provided | |||
| non-sterile. | Same | ||
| Materials | |||
| Outer layer | Spunbond Polypropylene | Polypropylene | Same |
| Middle filter layer | Melt blown Polypropylene | Meltblown | Same |
| Inner layer | Spunbond Polypropylene | Polypropylene | Same |
| Nose strip | PE and galvanized iron wire | Metal wires embedded in | |
| polyester or non-woven | |||
| ties | Similar | ||
| Note 1 | |||
| Ear loops for MK- | |||
| 34, DY 95, DY 97 | Nylon and Spandex | -- | Note 1 |
| Straps for DY 96 | Spun-bond polypropylene | -- | Note 1 |
| Ear attachment | Eastic earloop (for models MK- | ||
| 34, DY 95, DY 97) | Eastic earloop or Ties | Same | |
| Color | Blue | White | Different |
| Note 1 | |||
| Dimensions | MK-34: 145x95mm | ||
| DY 95, DY96, DY 97: | |||
| 175x95mm | Gent loop mask size: | ||
| 175x95mm | |||
| Lady loop mask size: | |||
| 145x95mm | |||
| Tie on mask size: | |||
| 175x95mm | Similar | ||
| Mask style | Flat pleated | Flat pleated | Same |
| Design features | 3 layers of non---woven fiber | ||
| with fiber web in the middle | 3 layers of non-woven fiber | ||
| with fiber web in the middle | Same | ||
| Sterile | Non-Sterile | ||
| Single use | Non-Sterile | ||
| Single use | Same | ||
| Shelf Life | 2 years | Not publicly available | Note 2 |
| Fluid Resistance | |||
| Performance | Pass at 120 mm Hg | Pass at 120 mm Hg | Same |
| Particulate | |||
| Filtration | |||
| Efficiency | Model MK-34, DY 95 and DY | ||
| 97: 98.9% | |||
| Model DY 96: 99.3% | 99.28% | Similar | |
| Note 3 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency | Model MK-34, DY 95 and DY | ||
| 97: 99.8% | |||
| Model DY 96: 99.9% | 99.66% | Similar | |
| Note 3 | |||
| Differential | |||
| Pressure | Model MK-34, DY 95 and DY | ||
| 97: 4.2 mm H2O/cm² | |||
| Model DY 96: 4.0mm H2O/cm² | 3.72 mm H2O/cm² | Similar | |
| Note 3 | |||
| Flammability | Class 1 | Class 1 | Same |
| Latex | Not made with natural latex | Not made with natural latex | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the | ||
| study, Non-cytotoxic | Non-cytotoxic | Same | |
| Irritation | Under the conditions of the | ||
| study, Non-irritating | Non-irritating | Same | |
| Sensitization | Under the conditions of the | ||
| study. Non- sensitization | Non- sensitization | Same |
Comparison in Detail(s):
7
Note 1:
Although the "Nose strip", "Ear loop", "Straps" and "Color" is a little different from the predicate devices, but it met the ISO 10993 standards and ASTM F2100 level II required. So, the differences between the subject device and the predicate device will not affect the safety and effectiveness.
8
Note 2:
Although the "Shelf life" of subject device is different from predicate device, but they all met the ASTM F2100 standard level II required after 81 days accelerated aging under 60°℃, so the difference between subject device and predicate device will not affect the safety and effectiveness.
Note 3: Although the "Particulate Filtration Efficiency ", "Bacterial Filtration Efficiency ", and "Differential Pressure" of subject device is a little different from predicate device, but they all met the ASTM F2100 standard level II required. So, the differences between the subject device and predicate device will not affect the safety and effectiveness.
8. Summary of Non-Clinical Performance Testing
| Test item
(Performance
Level 2 according
to ASTM F2100) | Test method | Pass
criteria | Test results |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------|
| Bacterial filtration
efficiency | ASTM F2101-14 Standard Test
Method for Evaluating the Bacterial
Filtration Efficiency (BFE) of
Medical Face Mask Materials,
Using a Biological Aerosol of
Staphylococcus aureus according
to ASTM F2100:2019 | ≥ 98% | Model MK-34,
DY 95 and DY
97: 99.8%
Model DY
96: 99.9%
Pass |
| Differential
pressure (Delta-P) | EN 14683: 2019, Annex C Medical
face masks - Requirements and
test methods according to ASTM
F2100:2019 |