(157 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to prevent the transfer of microorganisms and body fluids, indicating a prophylactic rather than a therapeutic function.
No
A surgical face mask is intended to protect from transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device description clearly outlines physical components (mask body, nose clip, ear ropes) made of materials like polypropylene, PE, nylon, and spandex. The performance studies also focus on physical properties and material testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical face mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency, breathability, and biocompatibility. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A surgical face mask does not fit this definition.
N/A
Intended Use / Indications for Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes.
The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven.
The nose clip 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 PE.
The ear ropes are made of nylon and spandex.
This is a single use, disposable device(s), provided non-sterile.
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 tests were conducted and conformed to 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 05, 2004.
Fluid Resistance Performance ( mmHg ): ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood. Acceptance Criteria: At least 29 out of 32 specimens show passing results at 160 mmHg. Results: Total 3 lots 96/96. All samples met the predetermined acceptance criteria.
Particulate Filtration Efficiency Performance (%): ASTM F2299 / F2299M - 03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. Acceptance Criteria: >= 98%. Results: 99.6% , total 3 lots 95 out of 96 samples met the predetermined acceptance criteria.
Bacterial Efficiency Performance (%): Filtration ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks. Acceptance Criteria: >= 98%. Results: >99.9%, total 3 lots 96/96 All samples met the predetermined acceptance criteria.
Differential (Delta-P) (mm H2O/cm2): Pressure ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks. Acceptance Criteria: 99.9%, total 3 lots 96/96 All samples met the predetermined acceptance criteria.
Differential (Delta-P): 2.2- 3.3 mm H2O/cm2, total 3 lots 96/96. All samples met the predetermined acceptance criteria.
Flammability: Total 3 lots 96/96 Did Not Ignite. All samples met the predetermined acceptance criteria.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 10, 2021
Sample King Manufacturing Ltd Forest Cao OC Manager Southwest side of the intersection of Mingzhu Boulevard and Shenyan Road, Yantian District Shenzhen, Guangdong 518083 China
Re: K210015
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 30, 2021 Received: May 3, 2021
Dear Forest Cao:
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
1
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,
Clarence W. Murray, III, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210015
Device Name Surgical Face Mask
Indications for Use (Describe)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the wansfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR $807.92.
The assigned 510(K) number is: K210015
1. Submitter Information:
Name: Sample King Manufacturing Ltd Address: 1001# 1st floor and 4011# 4th floor of HESC Building, southwest side of the intersection of Mingzhu Boulevard and Shenyan Road, Yantian District, 518083, Shenzhen, China
Contact Person: Ms. Forest Cao Position: Manager Tel : 0086-0755-33095566 Fax : 0086-0755-33095565 Email: forest.cao(@sampleking.com
Date of 510(k) Summary Prepared:2020-12-29
2. Device Information
Trade/Common Name: Surgical Face Mask Models: Ear loop type, 17.5cm×9.5cm Regulatory Class: Class II Regulatory Number: 21 CFR 878.4040 Review Panel: General Hospital Product Code: FXX (Mask, Surgical)
3. Predicative Device
Manufacturer: WUHAN DYMEX HEALTHCARE CO., LTD Device Name: Surgical Face Mask Model(s): Ear Loop 510(k) Number: K182515
4. Device Description:
Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes.
The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven.
4
The nose clip 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 PE.
The ear ropes are made of nylon and spandex.
This is a single use, disposable device(s), provided non-sterile.
5. Indication for Use
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
6. Technological Characteristic Comparison Table
Provided below is a comparison of the proposed device with predicate device.
| Table 1 Comparison of Technological characteristics | |||
|---|---|---|---|
| Item | Proposed device | Predicate Device | Comparison |
| Manufacturer | Sample King Manufacturing Ltd | WUHAN DYMEX HEALTHCARE CO., LTD | / |
| 510(k) Number | K210015 | K182515 | / |
| Product name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Indication for Use | The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same |
| Model | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same |
| Color | Blue and White | Yellow | Different |
| Materials Inner and Outer Layers | Blue PP non-woven (Outer Layers) | ||
| White PP non-woven (Inner Layers) | Spun-bond polypropylene | Similar |
Table 1 Comparison of Technological characteristics
5
| | Middle
Layer | | | | | | | |
|---------------|-----------------|-------------------------------|-----------------------------|--------------------------------|--|-----------|--|--|
| | | White
polypropylene filter | melt
blown
filter | Melt
blown
polypropylene | | Same | | |
| | Ear
ropes | Nylon+spandex | Spandex | | | Similar | | |
| | Nose
clip | Malleable polyethylene wire | Malleable polyethylene wire | | | Same | | |
| Sterile | | Non-sterile | Non-sterile | | | Same | | |
| Dimensions | | 17.5cm×9.5cm | 17.5cm×9.5cm | | | Same | | |
| Use | | Single Use, Disposable | Single Use, Disposable | | | Same | | |
| ASTM
Level | F2100 | Level 3 | Level 2 | | | Different | | |
7. Summary of Non-clinical Performance Testing
Non-clinical tests were conducted and conformed to 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 05, 2004.
| Item | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid Resistance | |||
| Performance ( mmHg ) | ASTM F1862: Standard Test Method for | ||
| Resistance of Medical Face Masks to Penetration | |||
| by Synthetic Blood | At least 29 out of 32 | ||
| specimens show passing | |||
| results at 160 mmHg | Total 3 lots 96/96. All | ||
| samples met the | |||
| predetermined acceptance | |||
| criteria. | |||
| Particulate Filtration | |||
| Efficiency | |||
| Performance (%) | ASTM F2299 / F2299M - | ||
| 03(2017) | |||
| Standard Test Method for | |||
| Determining the Initial | |||
| Efficiency of Materials | |||
| Used in Medical Face | |||
| Masks to Penetration by | |||
| Particulates Using Latex | |||
| Spheres | ≥ 98% | 99.6% , total 3 lots 95 | |
| out of 96 samples met the | |||
| predetermined acceptance | |||
| criteria. | |||
| Bacterial | |||
| Efficiency | |||
| Performance (%) | Filtration ASTM F2100-19: | ||
| Standard Specification for | |||
| Performance of | |||
| Materials Used in Medical | |||
| Face Masks | ≥ 98% | >99.9%, total 3 lots 96/96 | |
| All samples met the | |||
| predetermined acceptance | |||
| criteria. | |||
| Differential | |||
| (Delta-P) | |||
| (mm H2O/cm2) | Pressure ASTM F2100-19: | ||
| Standard Specification for | |||
| Performance of | |||
| Materials Used in Medical | |||
| Face Masks |