(112 days)
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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polyester/polypropylene). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
This document is a 510(k) Premarket Notification from the FDA regarding "Surgical Face Masks (Ear Loops And Tie-On)" manufactured by SAN-M PACKAGE CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device (K160269) by the same manufacturer.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject device are based on demonstrating substantial equivalence to the predicate device (K160269), which itself would have met specific performance standards. The performance tests are based on ASTM F2100-11 standards for medical face masks.
| Test Parameter / Acceptance Criteria (per ASTM F2100-11) | Subject Device Performance (San-M Surgical Masks) | Predicate Device Performance (K160269) | Comparison |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | |||
| Level 1: Pass at 80 mmHg | Pass at 80 mmHg | Pass at 80 mmHg | Equivalent |
| Level 2: Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Equivalent |
| Level 3: Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Equivalent |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | |||
| $\ge 98%$ | Pass at 99.6% (all levels) | Pass at 99.6% (all levels) | Equivalent |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | |||
| $\ge 98%$ (Level 1, 2) | Pass at >98% (Level 1, 2) | Pass at >98% (Level 1, 2) | Equivalent |
| $\ge 99%$ (Level 3) | Pass at >99.9% (Level 3) | Pass at >99% (Level 3) | Equivalent |
| Differential Pressure ($\Delta$P) (MIL-M-36945C) | |||
| <5.0 mm H2O/cm$^2$ | Pass at 2.0 mm H2O/cm$^2$ (Level 1) | Pass at 2.0 mm H2O/cm$^2$ (Level 1) | Equivalent |
| Pass at 1.6 mm H2O/cm$^2$ (Level 2) | Pass at 1.6 mm H2O/cm$^2$ (Level 2) | Equivalent | |
| Pass at 2.5 mm H2O/cm$^2$ (Level 3) | Pass at 2.5 mm H2O/cm$^2$ (Level 3) | Equivalent | |
| Flammability (16 CFR 1610) | |||
| Class 1 | Class 1 (all levels inferred) | Class 1 (all levels inferred) | Equivalent |
| Biocompatibility (ISO 10993) | |||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Equivalent |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating | Equivalent |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Equivalent |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance and biocompatibility testing program, as detailed in Table 3 of the submission. The key objective was to demonstrate that the subject device performs "as well as or better than the identified predicate device" (K160269) across all specified test parameters, and specifically that the change in nose clamp material (from polyethylene coated steel wire to just polyethylene) does not negatively impact performance, and allows for MR safety.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of masks tested) for each of the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility). However, it implies that the tests were conducted according to the relevant ASTM and ISO standards, which typically specify sample sizes for such evaluations.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer (SAN-M PACKAGE CO., LTD.) being located in Japan. The type of study is prospective non-clinical performance and biocompatibility testing conducted on the newly manufactured subject device and, for comparison, on the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in this context. The "ground truth" for a medical mask's performance is established by adherence to recognized performance standards (e.g., ASTM F2100-11, ISO 10993) and measured through objective laboratory tests. There is no concept of expert consensus or interpretation for these physical and biological performance characteristics.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where human reviewers make subjective assessments that might require a consensus. Performance tests for surgical masks are objective, standardized laboratory measurements that yield quantitative results (e.g., filtration efficiency percentages, pressure differentials, pass/fail for chemical tests).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging devices where multiple readers interpret cases to assess the effectiveness of an AI system, with and without AI assistance. The device in question is a surgical face mask, which does not involve human interpretation or AI assistance in its function or evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This concept applies to AI/ML software as a medical device (SaMD). The device under review is a physical medical device (surgical face mask), not an algorithm or software. Its performance is evaluated through direct physical and biological testing.
7. Type of Ground Truth Used
The "ground truth" for the performance of the surgical face masks is established through objective, standardized laboratory measurements against predefined thresholds and criteria outlined in recognized national and international standards (e.g., ASTM F2100-11 for mask performance, ISO 10993 for biocompatibility, 16 CFR 1610 for flammability, MIL-M-36945C for differential pressure). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather on physical and chemical properties and biological response.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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.
September 16, 2022
San-M Package Co., Ltd. % Takahiro Haruyama President Globizz Corporation 1411 W 190th St. Toyota Plaza #200 Gardena, California 90248
Re: K221534
Trade/Device Name: Surgical Face Masks (Ear Loops And Tie-On) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 24, 2022 Received: May 27, 2022
Dear Takahiro Haruyama:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221534
Device Name Surgical Face Masks (Ear Loops and Tie-On)
Indications for Use (Describe)
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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY for Surgical Face Masks (Ear loops and Tie-on)
1. Submission Sponsor
SAN-M PACKAGE CO., LTD. 1086-1 Ojiro Shimada-City Sizuoka, Japan 428-8652
2. Submission Correspondent
| Name : | Takahiro Haruyama |
|---|---|
| Title : | President, Globizz Corporation |
| Address: | 1411 W. 190th St., Ste. 200, Gardena, CA, 90248 |
| Phone: | (310) 538-3860 |
| Email: | register@globizz.net |
3. Date Prepared
Aug 11th, 2022
4. Device Identification
| Type of 510(k) : | Traditional 510(k) |
|---|---|
| Trade Name : | Surgical Face Masks (Ear loops and Tie-on) |
| Product Code : | FXX |
| Classification Name: | Surgical Mask |
| Regulation Number : | 21 CFR §878.4040 |
| Device Class: | Class II |
| Review Panel : | General & Plastic Surgery |
5. Legally Marketed Predicate Device
| Trade Name: | Surgical Face Masks (Ear loops and Tie-on) |
|---|---|
| 510(k) Number: | K160269 |
| Manufacturer: | SAN-M PACKAGE CO., LTD. |
6. Indication for Use
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
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potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.
Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010
7. Device Description
The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.
8. Model Numbers
| Mask Feature | Subject Device | Predicate Device(K160269) |
|---|---|---|
| Mask Style | Ear Loops | Ear Loops |
| Level 1 | EL 10000 | EL 10000 |
| Level 1 with Visor | EL 10010 | EL 10010 |
| Level 2 | EL 20000 | EL 20000 |
| Level 2 with Visor | EL 20010 | EL 20010 |
| Level 3 | EL 30000 | EL 30000 |
| Level 3 with Visor | EL 30010 | EL 30010 |
| Mask Style | Tie-On | Tie-On |
Table 1. Surgical Face Mask Model Comparison Table
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| Level 1 | TO 10000 | TO 10000 |
|---|---|---|
| Level 1 with Visor | TO 10010 | TO 10010 |
| Level 2 | TO 20000 | TO 20000 |
| Level 2 with Visor | TO 20010 | TO 20010 |
| Level 3 | TO 30000 | TO 30000 |
| Level 3 with Visor | TO 30010 | TO 30010 |
9. Technological Characteristics
The subject device, Surgical Face Masks (Ear Loops And Tie-On) is substantially equivalent to the legally marketed predicate device, K160269 Surgical Face Masks (Ear Loops And Tie-On). There is one major difference between these devices, which is the material of the nose clamp from polyethylene coated steel wire to just polyethylene which allows for use in MRI environments.
10. Substantial Equivalence Discussion
Table 2: Comparison of Predicate and Subject Device, Surgical Face Masks (Ear Loops and Tie-On).
| Feature | Subject Device | Predicate Device (160269) | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | ||
| Product Name | (New) Surgical Face Masks(Ear Loops And Tie-On) | (Our approved product)Surgical Face Masks (Ear loops And Tie-On) | Surgical Face Masks(Ear Loops and Tie-On) is San-M's previously approved |
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| product underK160269. | |||
|---|---|---|---|
| 510(k) Clearance | -- | K160269 | -- |
| Manufacturer | San-M Package Co., Ltd. | San-M Package Co., Ltd. | Equivalent. |
| Common Name | Surgical Mask | Surgical Mask | Equivalent. |
| Classification | Class II | Class II | Equivalent. |
| Product Code | FXX | FXX | Equivalent. |
| Intended Use | The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device, providednon-sterile. This mask issafe for use in the MRenvironment. | The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These facemasks are intended for usein infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposabledevice, provided non-sterile. | Additionalfunction of MRsafe.Rest isequivalent. |
| Materials | |||
| Outer Material | Polypropylene | Polypropylene | Equivalent. |
| Inner Material | Polypropylene | Polypropylene | Equivalent. |
| Filter Media | 1.Polypropylene2.Polypropylene meltblown | 1.Polypropylene2.Polypropylene meltblown | Equivalent. |
| Nose Clamp | Polyethylene | Polyethylene coated steelwire | Different. Steelwire is removedfrom noseclamp. New |
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K221534
Page 5 of 8
| material passedthebiocompatibility tests. Nodifferences inperformance. | |||||||
|---|---|---|---|---|---|---|---|
| Ear Loops/TieTapes | Ear loops: Polyester,polyurethaneSide tapes: Polyesterspunbond (ear loops maskonly)Tie tapes: Polypropylenespunbond or polyesterspunbond | Ear loops: Polyester,polyurethaneSide tapes: Polyesterspunbond (ear loops maskonly)Tie tapes: Polypropylenespunbond or polyesterspunbond | Equivalent. | ||||
| Design Features | •Colors: white or blue•Cup keeper option:polypropylene•Visor option: polyester | •Colors: white or blue•Cup keeper option:polypropylene•Visor option: polyester | Equivalent. | ||||
| Specifications andDimensions | Length: 175± 5mmWidth:90 ± 3mm | Length: 180± 5mmWidth:90 ± 3mm | Length: 175± 5mmWidth:90 ± 3mm | Length: 180± 5mmWidth:90 ± 3mm | Equivalent. | ||
| Mask Style | Flat-pleated | Flat-pleated | Equivalent. | ||||
| Sterility | Non-sterile | Non-sterile | Equivalent. | ||||
| PerformanceTesting (ASTMF2100-11) | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Equivalent. |
| Fluid Resistance | ASTM F1862 | ASTM F1862 | Equivalent. |
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| ParticulateFiltrationEfficiency | ASTM F2299 | ASTM F2299 | Equivalent. |
|---|---|---|---|
| Bacterial FiltrationEfficiency | ASTM F2101 | ASTM F2101 | Equivalent. |
| DifferentialPressure | MIL-M36945C | MIL-M36945C | Equivalent. |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | Equivalent. |
| Biocompatibility | ISO 10993 | ISO 10993 | Equivalent. |
Performance Testing:
The San-M Surgical Masks have been tested according to ASTM F2101-11.
Table 3: Comparison of performance and biocompatibility testing
| ASTM F2100-11 | Subject DeviceSan-M Surgical Masks | K160269 | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | ||
| Fluid Resistance(ASTM F1862) | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Equivalent |
| PFE(ASTM F2299):$\ge 98%$ | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6 % | Equivalent |
| BFE(ASTM F2101): | Pass at>98% | Pass at>98% | Pass at>99.9 % | Pass at>98% | Pass at>98% | Passat>99% | Equivalent |
| ≥ 98% | |||||||
| Δ P(MIL-M-36954C):<5.0 mmH2O/cm² | Pass at2.0 mmH2O/cm² | Pass at1.6 mmH2O/cm² | Pass at2.5 mmH2O/cm² | Pass at2.0 mmH2O/cm² | Pass at1.6 mmH2O/cm² | Passat 2.5mmH2O/cm² | Equivalent |
| Flammability(16 CFR 1610):Class 1 | Class 1 | Class 1 | Equivalent | ||||
| Cytotoxicity .ISO 10993-5 | Under the conditions ofthe study, the subjectdevice was non-cytotoxic. | Under the conditions of thestudy, the subject device wasnon-cytotoxic. | Equivalent | ||||
| Irritation ISO10993-10 | Under the conditions ofthe study, the subjectdevice was non-irritating. | Under the conditions of thestudy, the subject device wasnon-irritating. | Equivalent | ||||
| Sensitization ISO10993-10 | Under the conditions ofthe study, the subjectdevice was non-sensitizing. | Under the conditions of thestudy, the subject device wasnon-sensitizing. | Equivalent |
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11. Substantial Equivalence Conclusion
The subject device, Surgical Face Masks (Ear Loops and Tie-On) is substantially equivalent to the legally marketed predicate device, K160269 Surgical Face Masks (Ear Loops And Tie-On). There is one major difference between these devices, which is the material of the nose clamp from polyethylene coated steel wire to just polyethylene which allows for use in MRI environments. Therefore, we believe this device is regulated under the same regulation as K160269 Surgical Face Masks (Ear Loops and Tie-On): 21 CFR 878.4040 (Class II, Product code FXX for Masks, Surgical). The conclusions drawn for the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the identified predicate device.
§ 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.