(134 days)
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
The device (surgical mask) is intended to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or directly alleviate a medical condition. It functions as a barrier and is used for infection control rather than therapeutic intervention.
No
The document describes a surgical mask, which is a protective barrier, not a device used to diagnose a medical condition. Its intended use is to prevent the transfer of microorganisms and body fluids.
No
The device description clearly outlines a physical, multi-layered mask made of nonwoven polypropylene materials with ear-loops and a nosepiece. The performance studies also focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the surgical mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency, and flammability. These are tests of the device's ability to act as a barrier, not its ability to detect or measure substances in biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
In summary, a surgical mask is a personal protective equipment (PPE) device designed to prevent the spread of infectious agents through physical means. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical 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, provided non-sterile.
Product codes
FXX
Device Description
The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, 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
Not Found
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
Non-Clinical Test: The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the performance acceptance criteria and performed as effective as the predicate device.
Test Methodology: Fluid Resistance ASTM F1862
Purpose: Determine the ability of the mask's material to resist penetration of blood and body fluids.
Acceptance Criteria: Pass/fail basis at any of three velocities corresponding to the range of human blood pressure Level 1 – 80 mmHg Level 2 – 120 mmHg Level 3 - 160 mmHg
Results: Level 3 Passed at 160 mmHg. All 3 lots tested passed with no synthetic blood penetration observed at 160 mmHg, under the conditions of the test.
Test Methodology: Particulate Filtration Efficiency ASTM F2299
Purpose: Determine the ability of the mask's material to prevent passage of aerosolized submicron particulates.
Acceptance Criteria: Pass/fail basis Level 1 – 95% Level 2 – 98% Level 3 – 98%
Results: Level 3 Passed at > 99.9% Average Filtration Efficiency: AMSB-LOT202010007: >99.979% AMSB-LOT202011002: >99.9814% AMSB-LOT202011005: >99.984%
Test Methodology: Bacterial Filtration Efficiency ASTM F2101-19
Purpose: Determine the ability of the mask's material to prevent passage of aerosolized bacteria. Determine the resistance of the surgical facemask to air flowing through the mask.
Acceptance Criteria: Pass/fail basis Level 1 - 95% Level 2 – 98% Level 3 – 98% Pass/fail basis Level 1 –
§ 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 contains 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.
July 7, 2021
Changzhou Holymed Products Co., Ltd. Shan Shang Regulatory Correspondent 525 Changwu Road South Changzhou, Jiangsu 213167 China
Re: K210524
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 15, 2021 Received: April 20, 2021
Dear Shan Shang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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,
Clarence W. Murray, III. PhD 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)
Device Name
Surgical Mask
Indications for Use (Describe)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical 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, 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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Image /page/3/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue plus sign made up of rounded squares. The company name is in all caps and in a dark gray color.
510(k) Summary
510(k) Summary
Pursuant to 21 CFR 807.92
Prepared on April 14, 2021
1. Submitter
| Manufacturer Name and Address: | Changzhou Holymed Products Co., Ltd.
525 Changwu Road South
Wujin District, Changzhou
Jiangsu, China 213167 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Shan Shang |
| Telephone Number: | +86 183 5120 0602 |
| Email Address: | shan.shang@gogii.ca |
- Device Name
| Device Name: | Surgical Mask |
|---|---|
| Common Name: | Surgical Mask |
Regulatory Information:
| Classification Name: | Mask, Surgical |
|---|---|
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
3. Predicate
K160269 Level 3 Surgical Face Masks by San-M Package Co., Ltd. Particularly, the following model:
| Model # | Style |
|---|---|
| EL30000 | Ear-loop |
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Image /page/4/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol that resembles a plus sign with rounded edges, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left side of the logo, and the word "HOLYMED" is on the right side.
4. Device Description
The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, provided non-sterile.
| Product # | Style | Color |
|---|---|---|
| HM-02-01 | Ear-loop | Blue |
5. Intended Use/ Indication for Use
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical 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, provided non-sterile.
6. Comparison to Predicate
(a) Technological Characteristics
Summarized in Table 1 below is the comparison of the technological characteristics between the proposed and the predicate devices.
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Image /page/5/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol on the left and the word "HOLYMED" in gray on the right. The symbol is a stylized cross made up of rounded squares and a circle in the center.
| Table 1 - Technological Characteristics Comparison | |||
|---|---|---|---|
| Description | Proposed Device | Predicate Device | Comparison |
| 510(k) Number | K210524 | K160269 (EL30000) | N/A |
| Manufacturer | Changzhou Holymed Products | ||
| Co., Ltd. | San-M Package Co., Ltd. | N/A | |
| Common Name | Surgical Mask | Surgical Mask | Identical |
| Classification | Class II | Class II | Identical |
| Product Code | FXX | FXX | Identical |
| Intended Use | The surgical mask is intended | ||
| to be worn to protect both the | |||
| patient and healthcare | |||
| personnel from transfer of | |||
| microorganisms, body fluids | |||
| and particulate material. The | |||
| surgical 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, | |||
| 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 | |||
| materials. 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, provided non-sterile. | Identical | ||
| Material Composition | |||
| Outer Cover | Polypropylene spunbonded | Polypropylene | Similar |
| Middle Layer | Polypropylene melt-blown | 1. Polypropylene spunbond |
- Polypropylene meltblown | Similar |
| Inner Facing | Polypropylene spunbonded | Polypropylene | Similar |
| Nosepiece | Polyethylene laminated
aluminum | Polyethylene coated steel wire | Similar |
| Ear-loop | Knitted polyester/ elastane | Polyester, polyurethane. Side
tapes: Polyester spunbond
(ear loops mask only) | Similar |
| Colorant | Polypropylene masterbatch | Unknown | Similar |
| Dimensions | | | |
| Length | $95 \pm 3mm$ | $90 \pm 3 mm$ | Similar |
| Width | $175 \pm 3mm$ | $175 \pm 5 mm$ | Similar |
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Image /page/6/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol resembling a stylized plus sign or a network of interconnected nodes, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left, and the text is on the right.
| Design Features | Ear-loop | Ear-loop | Identical |
|---|---|---|---|
| Color | Blue | White or blue | Similar |
| Mask Style | Flat-pleated | Flat-pleated | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Use Frequency | Single-use, disposable | Single use, disposable | Identical |
| ASTM 2100 Level | Level 3 | Level 3 | Identical |
(b) Performance
- (i) Clinical Test: Not applicable.
- (ii) Non-Clinical Test:
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the performance acceptance criteria and performed as effective as the predicate device.
Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology.
Table 2: Non-Clinical Performance Testing Table
| Test
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid Resistance | |||
| ASTM F1862 | Determine the | ||
| ability of the | |||
| mask's material | |||
| to resist | |||
| penetration of | |||
| blood and body | |||
| fluids. | Pass/fail basis at any | ||
| of three velocities | |||
| corresponding to the | |||
| range of human blood | |||
| pressure | |||
| Level 1 – 80 mmHg | |||
| Level 2 – 120 mmHg | |||
| Level 3 - 160 mmHg | Level 3 | ||
| Passed at 160 mmHg. | |||
| All 3 lots tested passed with no | |||
| synthetic blood penetration | |||
| observed at 160 mmHg, under | |||
| the conditions of the test. | |||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2299 | Determine the | ||
| ability of the | |||
| mask's material | |||
| to prevent | |||
| passage of | |||
| aerosolized | |||
| submicron | |||
| particulates. | Pass/fail basis | ||
| Level 1 – 95% | |||
| Level 2 – 98% | |||
| Level 3 – 98% | Level 3 | ||
| Passed at > 99.9% | |||
| Average Filtration Efficiency: | |||
| AMSB-LOT202010007: >99.979% | |||
| AMSB-LOT202011002: |
99.9814%
AMSB-LOT202011005: >99.984% |
| Bacterial
Filtration
Efficiency
ASTM F2101-19
| Determine the
ability of the
mask's material
to prevent
passage of
aerosolized
bacteria.
Determine the
resistance of
the surgical
facemask to air
flowing through
the mask. | Pass/fail basis
Level 1 - 95%
Level 2 – 98%
Level 3 – 98%
Pass/fail basis
Level 1 –