(134 days)
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 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.
The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 mmHgLevel 2 – 120 mmHgLevel 3 - 160 mmHg | Level 3Passed 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 3Passed 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. | Pass/fail basis:Level 1 - 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at ≥ 99.9%All samples tested passed with a filtration efficiency percentage of at least 99.9%, under the conditions of the test. |
| Differential Pressure (ASTM F2101-19, same as BFE) | Determine the resistance of the surgical facemask to air flowing through the mask. | Pass/fail basis:Level 1 – <5 mm H2O/cm²Level 2 – <6 mm H2O/cm²Level 3 – <6 mm H2O/cm² | Level 1Passed, < 5 mm H2O/cm².AMSB-LOT202010007: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011002: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011005: ≤ 4.9 mm H2O/cm2. |
| Flammability (16 CFR Part 1610) | Determine the ability of the mask to resist ignition to an externally applied ignition source. | Pass/fail basis:Class 1, normal flammability specified in 16 CFR Part 1610. | Passed at Class 1All samples tested achieved a Class 1 flammability rating under the conditions of the test. |
Additionally, for safety (biocompatibility), Table 3: Summary of Biocompatibility Test Result and Comparison on page 8 details:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5) | Determine the biological response of mammalian cells in-vitro | Non-cytotoxic | Under the conditions of the study, non-cytotoxicity effect |
| Skin-irritation (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce skin irritation | Non-irritating | Under the conditions of the study, non-irritation |
| Sensitization (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce host sensitization | Non-sensitizing | Under the conditions of the study, non-sensitization |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For the Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency/Differential Pressure, and Flammability tests, the report states "All 3 lots tested" for fluid resistance and "All samples tested" for the other filtration/flammability tests, with specific lot numbers provided for filtration efficiency and differential pressure (AMSB-LOT202010007, AMSB-LOT202011002, AMSB-LOT202011005). The exact number of masks or specimens per lot is not explicitly stated, but it's implied that multiple samples were taken from these lots. ASTM and ISO standards for these tests typically specify precise sample quantities.
- Sample Size for Biocompatibility Tests: "All samples met the test criteria" is stated, but the exact number of samples or specimens per biocompatibility test (Cytotoxicity, Skin-irritation, Sensitization) is not specified.
- Data Provenance: The device manufacturer is Changzhou Holymed Products Co., Ltd. in Jiangsu, China. The testing appears to be non-clinical (laboratory-based) and conducted to conform to international standards (ASTM, ISO, CFR). The document does not specify where the testing was physically performed (e.g., in China or a certified third-party lab elsewhere), but it would typically be done in a lab accredited for these specific tests. The data is retrospective in the sense that it was collected as part of the 510(k) submission prior to the FDA's review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for performance of a surgical mask (e.g., filtration efficiency, fluid resistance) is objectively determined by standardized laboratory tests using established scientific methods and equipment, not by human expert opinion or consensus. Similarly, biocompatibility is assessed by laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. Since the performance metrics are objective physical measurements and chemical/biological assay results, there is no need for expert adjudication. The test results directly determine if the acceptance criteria are met.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are typically performed for diagnostic medical devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is evaluated. This 510(k) submission is for a physical product (surgical mask) that does not involve human interpretation or AI assistance in a diagnostic context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical mask, not an algorithm or software. The "standalone" performance here refers to the physical properties of the mask itself, which are tested through the described non-clinical laboratory studies. There is no algorithm involved.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective, standardized laboratory measurements against established national and international standards (ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards define the test methodologies and the acceptance criteria based on scientific principles relevant to the function and safety of a surgical mask.
- Fluid Resistance: Measured penetration of synthetic blood.
- Particulate Filtration Efficiency: Measured percentage of submicron particulates filtered.
- Bacterial Filtration Efficiency: Measured percentage of aerosolized bacteria filtered.
- Differential Pressure (Breathability): Measured resistance to airflow.
- Flammability: Measured ignition and burn rate.
- Biocompatibility: Measured cellular response (cytotoxicity), skin irritation, and sensitization potential.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device (surgical mask), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. The manufacturing process involves quality control, but not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set. As explained above, for a physical product like a surgical mask, the performance validation relies on standardized physical, chemical, and biological testing rather than machine learning models that require training and ground truth from data sets.
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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
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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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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 SouthWujin District, ChangzhouJiangsu, 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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| Table 1 - Technological Characteristics Comparison | |||
|---|---|---|---|
| Description | Proposed Device | Predicate Device | Comparison |
| 510(k) Number | K210524 | K160269 (EL30000) | N/A |
| Manufacturer | Changzhou Holymed ProductsCo., 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 intendedto be worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Thesurgical mask is intended foruse in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposable device,provided non-sterile. | The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single-use, disposabledevice, provided non-sterile. | Identical |
| Material Composition | |||
| Outer Cover | Polypropylene spunbonded | Polypropylene | Similar |
| Middle Layer | Polypropylene melt-blown | 1. Polypropylene spunbond2. Polypropylene meltblown | Similar |
| Inner Facing | Polypropylene spunbonded | Polypropylene | Similar |
| Nosepiece | Polyethylene laminatedaluminum | Polyethylene coated steel wire | Similar |
| Ear-loop | Knitted polyester/ elastane | Polyester, polyurethane. Sidetapes: 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
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid ResistanceASTM F1862 | Determine theability of themask's materialto resistpenetration ofblood and bodyfluids. | Pass/fail basis at anyof three velocitiescorresponding to therange of human bloodpressureLevel 1 – 80 mmHgLevel 2 – 120 mmHgLevel 3 - 160 mmHg | Level 3Passed at 160 mmHg.All 3 lots tested passed with nosynthetic blood penetrationobserved at 160 mmHg, underthe conditions of the test. |
| ParticulateFiltrationEfficiencyASTM F2299 | Determine theability of themask's materialto preventpassage ofaerosolizedsubmicronparticulates. | Pass/fail basisLevel 1 – 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at > 99.9%Average Filtration Efficiency:AMSB-LOT202010007: >99.979%AMSB-LOT202011002:>99.9814%AMSB-LOT202011005: >99.984% |
| BacterialFiltrationEfficiencyASTM F2101-19 | Determine theability of themask's materialto preventpassage ofaerosolizedbacteria.Determine theresistance ofthe surgicalfacemask to airflowing throughthe mask. | Pass/fail basisLevel 1 - 95%Level 2 – 98%Level 3 – 98%Pass/fail basisLevel 1 – <5 mmH2O/cm²Level 2 – <6 mmH2O/cm²Level 3 – <6 mmH2O/cm² | Level 3Passed at ≥ 99.9%All samples tested passed with afiltration efficiency percentage ofat least 99.9%, under theconditions of the test.Level 1Passed, < 5 mm H2O/cm².AMSB-LOT202010007: ≤ 3.7 mmH2O/cm2.AMSB-LOT202011002: ≤ 3.7 mmH2O/cm2.AMSB-LOT202011005: ≤ 4.9 mmH2O/cm2. |
| Flammability16 CFR Part 1610 | Determine theability of themask to resistignition to anexternallyapplied ignitionsource. | Pass/fail basisClass 1, normalflammability specifiedin 16 CFR Part 1610. | Passed at Class 1All samples tested achieved aClass 1 flammability rating underthe conditions of the test. |
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Image /page/7/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is written in gray, block letters.
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Image /page/8/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is in all caps and in a dark gray color.
(c) Safety
To address the safety risks from wearing of the surgical mask, biocompatibility tests were performed according to the standard ISO 10993 as referenced in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the test criteria and are as safe as the predicate device. Test results are summarized in Table 3 below.
| Table 3: Summary of Biocompatibility Test Result and Comparison | |||||||
|---|---|---|---|---|---|---|---|
| TestMethodology | Purpose | Acceptance Criteria | Results | ||||
| CytotoxicityISO 10993-5 | Determine the biologicalresponse of mammaliancells in-vitro | Non-cytotoxic | Under the conditions ofthe study, non-cytotoxicity effect | ||||
| Skin-irritationISO 10993-10 | Assess the potential of amedical device and itsconstituent materials toproduce skin irritation | Non-irritating | Under the conditions ofthe study, non-irritation | ||||
| SensitizationISO 10993-10 | Assess the potential of amedical device and itsconstituent materials toproduce host sensitization | Non- sensitizing | Under the conditions ofthe study, non-sensitization |
(d) Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K210524, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
§ 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.