(200 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
This document describes the non-clinical testing performed to demonstrate that the Allmed Medical Products Co., Ltd. Surgical Mask is substantially equivalent to a predicate device (K153496). The acceptance criteria and performance data are based on standard test methods for surgical masks.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (level 2) | Reported Device Performance** (Proposed device) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 29 out of 32 pass at 120 mmHg | 31, 30, 32 out of 32 pass at 120 mmHg, 3 lots | Similar |
| Particulate Filtration Efficiency (PFE) ASTM F2299 | ≥ 98% | Pass at 99.85%, 99.90%, 99.75% | Similar |
| Bacterial Filtration Efficiency (BFE) ASTM F2101 | ≥ 98% | Pass at 99.9%, 99.9%, 99.9% | Similar |
| Differential Pressure (Delta P) EN 14683 Annex C | < $6.0mmH_2O/cm^2$ | Pass at $4.6mmH_2O/cm^2$, $4.5mmH_2O/cm^2$, $4.6mmH_2O/cm^2$ | Similar |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Same |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | Same |
| Irritation (ISO 10993-10) | Non-irritating | Under the conditions of the study, the device is non-irritating. | Same |
| Sensitization (ISO 10993-10) | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing. | Same |
Note: The term "Similar" in the "Result" column implies that the proposed device met or exceeded the performance of the predicate device and the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F1862): 3 lots were tested, with each lot likely consisting of 32 samples (as the criteria specifies "29 out of 32 pass"). Data provenance is not explicitly stated but implied to be from laboratory testing performed by or for the manufacturer.
- Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683 Annex C): The report indicates performance from multiple tests (e.g., three percentages for PFE/BFE, three pressure values for Delta P), suggesting at least 3 samples were tested for each.
- Flammability (16 CFR 1610): Sample size not specified, but typically involves a set number of specimens from the material.
- Biocompatibility (ISO 10993-5, -10): Sample sizes for "in vitro" and "in vivo" (for irritation/sensitization) tests are defined by the respective ISO standards, but not explicitly stated in this summary.
Data Provenance: The data appears to be from non-clinical laboratory testing (bench testing) of the device. The country of origin of the data is not explicitly stated, but the manufacturer is based in China. The testing is assumed to be prospective, performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a surgical mask focusing on physical and biological performance characteristics measured through standardized laboratory tests, not subjective expert evaluation of data like medical image analysis. The "ground truth" is established by the specifications of the test standards themselves (e.g., a specific percentage filtration efficiency, a defined pressure drop).
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is objectively measured by established laboratory test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is typically used for diagnostic devices that involve human interpretation of medical images or data. Surgical masks are medical devices with mechanical and biological filtration properties, evaluated through non-clinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The core of this submission relies on "standalone" performance testing of the device itself (the surgical mask) against established standards. There is no "human-in-the-loop" component in evaluating the fundamental performance characteristics of the mask (e.g., BFE, PFE, fluid resistance).
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by international and national consensus standards and regulatory guidelines (e.g., ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993 series). These standards define the methodology and the acceptable performance thresholds for surgical masks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product (surgical mask) whose performance is evaluated through specified tests.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows 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.
March 9, 2021
Allmed Medical Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202409
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2021 Received: February 11, 2021
Dear Ivy Wang:
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.
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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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202409
Device Name Surgical Mask Ear loops
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| 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 and address of Allmed Medical Products Co., Ltd. The logo features the company name in gray and green, with a stylized "A" symbol above the name. The address is listed as No. 99, Jin Shan Road, Majiadian Town, Zhijiang City, Hubei, CHINA.
510(K) Summary
K202409
Date of Summary prepared: 2021-03-09
A. Applicant:
Allmed Medical Products Co., Ltd. Address: No. 99, Jin Shan Road, Majiadian Town,Zhijiang City, Hubei, CHINA Contact person: Vince Tian Tel: +86-717-4211111 Fax: +86-717-4225499
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.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
B. Device:
Trade Name: SURGICAL MASK Common Name: SURGICAL FACE MASK Model: Ear loops (LP121016)
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd.
D. Intended use of the device:
The surgical masks are intended to be worn to protect both the patient and healthcare personnel
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Image /page/4/Picture/0 description: The image shows the logo and address of Allmed Medical Products Co., Ltd. The logo consists of the word "ALLMED" in gray and green, with a stylized "A" above it. The address is "No. 99, Jin Shan Road, Majiadian Town, Zhijiang City, Hubei, CHINA".
from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Masks are blue color, single use, three-layer, flat -folded masks with nose clip and ear loops.
The Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron strip wrapped by plastic.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
| Comparison with predicate device | ||||
|---|---|---|---|---|
| -- | ---------------------------------- | -- | -- | -- |
| Proposed Device | Predicate Device | Result | ||
|---|---|---|---|---|
| Manufacturer | Allmed Medical Products Co., Ltd. | Xiantao Rayxin Medical Products Co., ltd. | ||
| 510K number | K202409 | K153496 | ||
| Model Name | SURGICAL MASK | SURGICAL FACE MASK | Similar | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intend use | The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Same | |
| Design Features | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | Similar | |
| Material | Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
Table 1 General Comparison
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Image /page/5/Picture/0 description: The image shows a logo with a stylized letter 'A' in gray at the top, with a white plus sign in the middle. Below the gray 'A' is a green stylized letter 'M'. The text 'ALLMED' is in gray at the bottom left, and 'No. 9' is in gray at the bottom right.
Allmed Medical Products Co., Ltd.
ED No. 99, Jin Shan Road, Majiadian Town,Zhijiang City, Hubei, CHINA
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
|---|---|---|---|---|
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | iron strip wrapped by plastic | Malleable aluminum wire | Different | |
| Ear loops | Spandex elastic | Polyester | Different | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | $17.5cm\pm0.8cm$ | $17.5cm\pm1cm$ | Similar | |
| Dimension (Width) | $9.5cm\pm0.9cm$ | $9.5cm\pm1cm$ | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Biocompatibility | ISO10993 | ISO10993 | Same |
Table 2 - Comparison of Performance Testing
| Item | Proposed device | Predicate device | AcceptanceCriteria (level 2) | Result |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | 31, 30, 32 out of 32pass at 120 mmHg, 3lots | 32 out of 32 pass at120 mmHg | 29 out of 32 passat 120 mmHg | Similar |
| ParticulateFiltrationEfficiency ASTMF2299 | Pass at 99.85%,99.90%, 99.75% | Pass at 98.46% | ≥ 98% | Similar |
| BacterialFiltrationEfficiency ASTMF2101 | Pass at 99.9%,99.9%, 99.9% | Pass at 98.7% | ≥ 98% | Similar |
| DifferentialPressure (DeltaP) EN 14683Annex C | Pass at$4.6mmH_2O/cm^2$ ,$4.5mmH_2O/cm^2$ ,$4.6mmH_2O/cm^2$ | Pass at$4.2mmH_2O/cm^2$ | < $6.0mmH_2O/cm^2$ | Similar |
| Flammability 16CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
Table 3 Biocompatibility Comparison
| Item | Proposed device | Predicate device | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Under the conditions of the study, the device is non-cytotoxic. | Same |
| Irritation | Under the conditions of the study, | Under the conditions of | Same |
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Image /page/6/Picture/0 description: The image shows a logo for a company or organization, featuring a stylized letter "A" with a plus sign incorporated into its design. The top part of the "A" is gray, while the lower part is green. The plus sign is formed by the negative space between the two parts of the "A". The logo has a modern and clean design.
Allmed Medical Products Co., Ltd. > No. 99, Jin Shan Road, Majiadian Town,Zhijiang City, Hubei, CHINA
| the device is non-irritating. | the study, the device isnon-irritating. | ||
|---|---|---|---|
| Sensitization | Under the conditions of the study,the device is non-sensitizing | Under the conditions ofthe study, the device isnon-sensitizing | Same |
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device. The test results demonstrated that the proposed 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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202409, the surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.
§ 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.