(143 days)
The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 sterile.
The model EH-1 is made of mask body, nose clip, ear loops and nose pad, whit color. The model EH-2 is made of mask body, nose clip, straps and nose pad, green color.
The mask body is manufactured with three layers, the inner and outer layers are made of nonwoven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The straps and ear loops are held in place over the users' mouth and nose by two elastic straps welded to the mask body. It is made of nylon & spandex.
The nose clip in the layers of mask body is to allow the user to fit the mask body around their nose. It is made of polypropylene plastic wrapped metallic wire.
The nose pad which is made by 100% polyurethane is placed between the nose bridge and the mask body to let the user feel comfortable.
The buckle is use to clamp the ear loops and adjust the length and tightness of the mask. It is made of Polypropylene.
The colorant of white (EH-1)is Titanium dioxide, CAS Number is 13463-67-7; and the colorant of green(EH-2) is Pigment Green 7, CAS Number is 1328-53-6.
The EH-1 will be provided in white and the EH-2 will be provided in green. The Surgical Masks are sold sterilized with ethylene oxide gas and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and results for a Surgical Mask (device name). It details non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (EH-1 & EH-2) |
|---|---|---|
| Synthetic Blood Penetration Resistance (ASTM F1862) | ≥ 29 samples out of 32 pass (AQL 4%) | Level 3 pass at 160mmHg (both models pass at 160mmHg) |
| Differential Pressure (Delta P) (EN 14683) | 29 out of 32 pass | Level 3 pass at ≤ 6.0 mmH20/cm2 (both models are ≤ 6.0 mmH20/cm2) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | 29 out of 32 pass | Level 3 pass at ≥98% (both models are ≥98%) |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | 29 out of 32 pass | Level 3 pass at ≥98% (both models are ≥98%) |
| Flammability (16 CFR 1610) | Class I | Class I |
| Cytotoxicity (ISO 10993-5) | Under the conditions of the study, the device is non-cytotoxic. | Non-cytotoxic |
| Skin Irritation (ISO 10993-10) | Under the conditions of the study, the device is non-irritating. | Non-irritating |
| Skin Sensitization (ISO 10993-10) | Under the conditions of the study, the device is non-sensitizing. | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Physical Performance Tests (e.g., Blood Penetration, BFE, PFE, Delta P): The acceptance criteria explicitly state "≥ 29 samples out of 32 pass". This indicates that 32 samples were likely used for these specific tests for each model (EH-1 and EH-2).
- Sample Size for Biocompatibility Tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The specific sample sizes for these tests are not provided in the document, only the qualitative results.
- Data Provenance: The document states "non-clinical tests were conducted to verify that the subject device met all design specifications." The manufacturer is Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA. The tests appear to be prospective as they were conducted to demonstrate compliance for this specific device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This study involved non-clinical performance testing of a physical device (surgical mask) against established industry standards (e.g., ASTM, EN, ISO, CFR). Ground truth is established by the test methods themselves and their quantifiable outcomes, not by expert consensus or interpretation of medical images/data.
4. Adjudication Method for the Test Set:
- Not applicable. As stated above, this is non-clinical performance testing against objective standards, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a submission for a surgical mask, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (surgical mask). There is no algorithm involved.
7. The Type of Ground Truth Used:
- The ground truth for the device's performance is established by objective, quantitative measurements against recognized international standards (ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific test procedures and criteria for evaluating properties like bacterial filtration efficiency, blood penetration resistance, differential pressure, flammability, and biocompatibility.
8. The Sample Size for the Training Set:
- Not applicable. This refers to non-clinical testing of a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See explanation for 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 4, 2022
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K213358
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 23, 2022 Received: February 23, 2022
Dear Eva Li:
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) K213358
Device Name Surgical Mask
Indications for Use (Describe)
The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 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
A. 510(k) Number: K213358
B. Sponsor
Shenzhen SafeSecure Medical Infection Control Tech Co.,Ltd. Address: 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District, 518109 Shenzhen City, Guangdong, PEOPLE'S REPUBLIC OF CHINA Contact Person: Patty Chen Position: Marketing Manager Tel: +86-755-27040468 Email: patty.chen@anbaopack.com
C. Date Prepared: Jan 23th, 2022
D. Submission Correspondent
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
E. Subject Device
Trade Name: Surgical Mask Model(s):
| Model# | Description |
|---|---|
| EH-1 | Folded form with ear loops,3 layers, white color |
| EH-2 | Folded form with head straps, 3 layers, green color |
Regulatory Information
Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
F. Predicate device:
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K110455 Kimberly-Clark KC100 Mask Kimberly-Clark
G. Indications for use:
The Surgical Mask intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These devices 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 sterile.
H. Device Description:
The model EH-1 is made of mask body, nose clip, ear loops and nose pad, whit color. The model EH-2 is made of mask body, nose clip, straps and nose pad, green color.
The mask body is manufactured with three layers, the inner and outer layers are made of nonwoven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The straps and ear loops are held in place over the users' mouth and nose by two elastic straps welded to the mask body. It is made of nylon & spandex.
The nose clip in the layers of mask body is to allow the user to fit the mask body around their nose. It is made of polypropylene plastic wrapped metallic wire.
The nose pad which is made by 100% polyurethane is placed between the nose bridge and the mask body to let the user feel comfortable.
The buckle is use to clamp the ear loops and adjust the length and tightness of the mask. It is made of Polypropylene.
The colorant of white (EH-1)is Titanium dioxide, CAS Number is 13463-67-7; and the colorant of green(EH-2) is Pigment Green 7, CAS Number is 1328-53-6.
The EH-1 will be provided in white and the EH-2 will be provided in green. The Surgical Masks are sold sterilized with ethylene oxide gas and are intended to be single use, disposable devices.
I. Technological Characteristic Comparison
| Device | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | ShenzhenSafeSecureMedicalInfection Control Tech Co.,Ltd. | Kimberly-Clark | ||
| 510(K) number | K213358 | K110455 | ||
| Model Name | EH-1, EH-2 | Kimberly-Clark KC100 Mask | -- | |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same | |
| Indications for use | The Surgical Masks are intended to be worn toprotect both the patient and healthcarepersonnel from transfer of microorganisms,body fluids and particulate material. Theseface masks are intended for use in infectioncontrol practices to reduce the potentialexposure to blood and body fluids. This is asingle use, disposable device(s), provided non-sterile. | The Kimberly-Clark KC100 ProcedureMask(s) is intended to be worn toprotect both the patient andhealthcare personnel from transferof microorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. The Kimberly-ClarkKC100 Procedure Mask(s) is a singleuse, disposable devices,provided non-sterile. | Same | |
| Description | EH-1: Folded form with ear loops, 3 layers,white colorEH-2: Folded form with headstraps, 3 layers, green color | Ear Loops, Tie-On, Flat Pleated, 3layers | Different. | |
| Material | Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | polypropylene plastic wrappedmetallic wire | N/A | Different. | |
| Nose pad | 100% polyurethane | N/A | Different. | |
| Ear loops | Nylon& Spandex | Polyester/lycra knitted | Different. | |
| Head straps | Nylon& Spandex | N/A | Different. | |
| Buckle | polypropylene | N/A | Different. | |
| Color | Green/white | Variety (include blue) | Similar | |
| Dimension (length) | 1/2 length:108 $\pm$ 5mm(EH-1)1/2 length:106 $\pm$ 5mm(EH-2) | 165 $\pm$ 19mm | Different. | |
| Dimension (width ) | 155 $\pm$ 5mm(EH-1)165 $\pm$ 5mm(EH-2) | 102 $\pm$ 19mm | Different. | |
| OTC use | Yes | Yes | Same |
Table 1 General Comparison
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Shenzhen SafeSecure Medical Infection Control Tech Co.,Ltd 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District, 518109 Shenzhen City, Guangdong, PEOPLE'S REPUBLIC OF CHINA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Shenzhen SafeSecure Medical Infection Control Tech Co.,Ltd 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District, 518109 Shenzhen City, Guangdong, PEOPLE'S REPUBLIC OF CHINA
| Sterility | Sterile | Non-Sterile | Different |
|---|---|---|---|
| Use | Single use, Disposable | Single use, Disposable | Same | |
|---|---|---|---|---|
| ASTM F2100 Level | Level 3 | Level 1 | Similar. | |
| Biocompatibility | Cytotoxicity ISO10993-5 | Non-cytotoxic under the conditionsof the study | Non-cytotoxic under theconditions of the study | Same |
| Skin Sensitivity ISO10993-10 | Non-sensitizer under theconditions of the study | Non-sensitizer under theconditions of the study | Same | |
| Skin IrritationISO 10993-10 | Non-irritating under the conditionsof the study | Non-irritating under theconditions of the study | Same |
The proposed device has different design to the predicate device, and because the different design so the proposed device has nose pad and buckle which the predicate device does not include. The dimensions differ, and the material of nose clip and ear loops/head straps and the color is different to the predicate device, the sterility of the proposed device is different to the predicate device. The subject device conducted testing to demonstrate compliance with ASTM F2100 with the different models meeting the Level 3 criteria, while the predicate device met the ASTM F2100 Level 1 criteria.
Summary of Non-Clinical Performance Testing.
Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with 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 5, 2004:
| Test Method | Purpose |
|---|---|
| ASTM F2100, Standard Specification forPerformance of Materials Used in MedicalFace Masks | This specification defines the minimum performancerequirements for materials used in the construction ofmedical face masks. |
| ASTM F1862, Standard Test Method for Resistance ofMedical Face Masks to Penetration by Synthetic Blood(Horizontal Projection of Fixed Volume at A KnownVelocity) | Determine the ability of a mask to resist penetration ofsimulated blood |
| ASTM F2101, Standard Test Method for Evaluating theBacterial Filtration Efficiency (BFE) Of Medical FaceMask Materials, Using A Biological Aerosol ofStaphylococcus Aureus | Determine the ability of a mask to resist penetration ofmicrobiological organisms |
| ASTM F2299, Standard test method for determiningthe initial efficiency of materials used in medical facemasks to penetration by particulates using latexspheres | Determine the ability of a mask to resist penetration bymicroscopic particulates |
| Differential Pressure (Delta P) (EN14683) | Determine the resistance of a mask to air flow |
| 16 CFR 1610, Standard for the Flammability of clothingtextiles | Determine the ability of a mask to resist ignition from anexternally supplied source |
Table 2a-Performance Testing Plan
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> Table 2b-Performance Testing Result
| Lot No. | Test | Acceptance Criteria | Test Result | |
|---|---|---|---|---|
| Model EH-1 | Synthetic Blood PenetrationResistance PerformanceASTM F1862 | ≥ 29 samples out of 32pass (AQL 4%) | Level 3 pass at 160mmHg | pass at 160mmHg |
| Lot 01EH01F20210-1 | ||||
| Model EH-1 | Differential Pressure (Delta P)(EN14683) | 29 out of 32 pass | Level 3 pass at ≥98% | ≥98% |
| Lot 01EH01F20210-4 | ||||
| Model EH-1 | Bacterial FiltrationEfficiency (ASTMF2101) | 29 out of 32 pass | Level 3 pass≤ 6.0 mmH20/cm2 | ≤ 6.0 mmH20/cm2 |
| Lot 01EH01F20210-6 | ||||
| Model EH-1 | Particulate Filtration EfficiencyASTM F2299 | 29 out of 32 pass | Level 3 pass at ≥98% | ≥98% |
| Lot 01EH01F20210-6 | ||||
| Model EH-1 | Flammability 16 CFR 1610 | Class I | Class I | |
| Lot 01EH01F20210-6 | ||||
| Model EH-2 | Synthetic Blood PenetrationResistancePerformance ASTMF1862 | ≥ 29 samples out of 32pass (AQL 4%) | Level 3 pass at 160mmHg | pass at 160mmHg |
| Lot 01EH02F20210-2 | ||||
| Model EH-2 | Differential Pressure (Delta P)(EN14683) | 29 out of 32 pass | Level 3 pass at ≥98% | ≥98% |
| Lot 01EH02F20210-4 | ||||
| Model EH-2 | Bacterial FiltrationEfficiency (ASTMF2101) | 29 out of 32 pass | Level 3 pass≤ 6.0 mmH20/cm2 | ≤ 6.0 mmH20/cm2 |
| Lot 01EH02F20210-4 | ||||
| Model EH-2 | Particulate Filtration EfficiencyASTM F2299 | 29 out of 32 pass | Level 3 pass at ≥98% | ≥98% |
| Lot 01EH02F20210-7 | ||||
| Model EH-2 | Flammability 16 CFR1610 | Class I | Class I | |
| Lot 01EH02F20210-7 |
| Item | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity ISO10993-5 | Demonstratecytotoxicbiocompatibility | Under the conditions of the study, the device is non-cytotoxic. | No cytotoxic |
| Skin IrritationISO 10993-10 | Demonstrate non-irritability | Under the conditions of the study, the device isnon-irritating. | non-irritability |
| Skin SensitizationISO 10993-10 | Demonstrate non-sensitization | Under the conditions of the study, the device isnon-sensitizing | non-sensitization |
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B. Summary of Clinical Performance Tests
No clinical study is included in this submission.
L. Conclusion
Based on the nonclinical tests performed, the subject Surgical Masks are as safe, as effective, and perform as well as or better than the legally marketed predicate device, Kimberly-Clark KC100 Mask cleared under K110455.
§ 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.