(307 days)
Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.
Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
The document describes the acceptance criteria and performance of the Allmed Surgical Face Masks (Ear Loops) as per their 510(k) summary. This is not a study of an AI-powered device, but rather a regulatory submission for a medical device (surgical face mask). Therefore, information related to AI-specific studies, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable or present in this document.
Here's the information available:
1. Table of acceptance criteria and the reported device performance:
| Test Method (Test Identification) | Purpose (summarized) | Acceptance Criterion (ASTM F2100 Level 3) | Test Result |
|---|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | Compare bacterial control counts upstream and downstream to determine filtration efficiency. | ≥98%, AQL=4% | Passed |
| ASTM F2299-Particulate Filtration Efficiency (PFE) | Evaluate non-viable particle filtration efficiency. | ≥98%, AQL=4% | Passed |
| EN14683:2019 Annex C-Differential Pressure | Determine breathability by measuring differential air pressure. | <6.0 mmH2O/cm2, AQL=4% | Passed |
| ASTM F1862-Fluid Resistance | Simulate surgical mask spray and evaluate protection from blood/body fluids. | Resistant at 160mmHg, 4% AQL | Passed |
| 16 CFR 1610-Flammability | Evaluate ease of ignition and speed of flame spread. | Class 1 | Passed |
| Biocompatibility-Cytotoxicity (ISO 10993-5: 2009) | Assess cytotoxicity. | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility-Skin Irritation (ISO 10993-10: 2010) | Assess skin irritation. | Non-irritating | Non-irritating |
| Biocompatibility-Skin Sensitization (ISO 10993-10: 2010) | Assess skin sensitization. | Non-sensitizing | Non-sensitizing |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each performance test (e.g., number of masks tested for BFE, PFE, etc.). It mentions AQL (Acceptable Quality Level) values for some tests, which implies a sampling plan was used, but the specific sample size "n" is not provided. The data provenance is presumed to be from testing conducted by or for Allmed Medical Products Co., LTD, based in China (No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province), as they are the submitter of the 510(k). The tests appear to be a prospective evaluation of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (surgical face mask) performance evaluation against established ISO/ASTM standards, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable. Device performance is determined by passing predefined thresholds in standardized laboratory tests, not by expert adjudication.
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:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
The "ground truth" for the performance criteria is based on established international standards (ASTM, EN, ISO, CFR) for surgical face masks. These standards define the acceptable physical and biological properties for the device to perform its intended function.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.
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June 3, 2021
Allmed Medical Products Co., LTD Vince Tian General Manager of Quality No. 180 Gongyuan Road Majiadian Town Zhijiang, Hubei 443200 China
Re: K202128
Trade/Device Name: Allmed Surgical Face Masks (Ear loops) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 3, 2021
Dear Vince Tian:
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 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) K202128
Device Name Allmed Surgical Face Masks (Ear Loops)
Indications for Use (Describe)
Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Allmed. The logo consists of a gray triangle on top of a green stylized letter "M". A white plus sign is in the middle of the gray triangle. The word "ALLMED" is written in gray, block letters below the symbol.
510(k) SUMMARY
| 510(k) Number: | K202128 |
|---|---|
| ---------------- | --------- |
510(k) Premarket Notification for Allmed Surgical Face Masks (Ear Loops)
This 510(K) summary is being submitted in accordance with the requirement of 21 CFR 807.92.
| 1. Submitter: | ALLMED MEDICAL PRODUCTS CO., LTD |
|---|---|
| No.180, GongYuan Road, Majiadian Town, Zhijiang City, | |
| Hubei Province, China 443200 | |
| Phone: +86-717-4211111 | |
| Fax: +86-717-4225499 |
| 2. Regulatory Affairs Contact: | Ruby Qiu |
|---|---|
| Regulatory Affairs Manager 19F, Block A, Taurus Plaza | |
| No.8 Taoyuan Rd, Nanshan District Shenzhen City | |
| Guangdong, China 518055 | |
| Telephone Number: 631-656-3800 ext. 133 | |
| Fax Number: 631-656-3810 |
| 3. Date Prepared: | April 20, 2021 |
|---|---|
| ------------------- | ---------------- |
| 4. Device Identification: | Name: Allmed Surgical Face Masks (Ear Loops) |
|---|---|
| Trade Name: Allmed Surgical Face Masks (Ear Loops) | |
| Common/Classification Name: Surgical Mask | |
| Regulation Number: 21 CFR §878.4040 | |
| Device Class: Class II | |
| Regulation Name: Surgical Apparel | |
| Product Code: FXX |
| 5. Predicate Device: | 510(k) Number: K160269 |
|---|---|
| Name: Surgical Face Masks (Ear loops and Tie-on) | |
| Trade Name: Surgical Face Masks (Ear loops and Tie-on) | |
| Common/Classification Name: Masks, Surgical | |
| Regulation Number: 21 CFR §878.4040 | |
| Device Class: Class II | |
| Regulation Name: Surgical Apparel | |
| Product Code: FXX | |
| Manufacturer: SAN-M PACKAGE CO., LTD. |
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ALLMED MEDICAL PRODUCTS CO., LTD
No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: +86-717-4211111 Fax: +86-717-4225499
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- Device Description: Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
-
- Indications for Use: Allmed Surgical Face Masks(Ear Loops)are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.
| Element ofComparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K202128 | K160269 | |
| Trade Name | Allmed Surgical Face Masks(Ear Loops) | Surgical Face Masks (Ear loopsand Tie-on) | |
| Manufacturer | ALLMED MEDICAL PRODUCTS CO.,LTD | SAN-M PACKAGE CO., LTD. | |
| General | |||
| Indications for Use | Allmed Surgical Face Masks(EarLoops) are intended to be wornto protect both patients andhealthcare workers from transferof microorganisms, body fluids,and particulate material. Thesurgical face mask is intended foruse in infection control practicesto reduce the potential exposure | The surgical mask is intended to beworn to protect both patients andhealthcare workers from transfer ofmicroorganisms, body fluids, andparticulate material. The surgicalmask is intended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. The surgical mask is a | Same |
| to blood and body fluids. Thesurgical face mask is a single use,disposable device providednon-sterile. | single use, disposable deviceprovidednon-sterile. | ||
| Material Composition | Three-layer mask constructed of:Outer layer: PolypropyleneSpunbondFilter layer: PolypropyleneMeltblownInner layer: PolypropyleneSpunbondEar loops: Spandex elastic,polyesterNose Piece: Malleable Iron wirewith plastic cover/Polypropylene | Three-layer mask constructed of:Outer layer: spunbondpolypropyleneFilter layer: meltblownpolypropyleneInner layer: spunbond polypropyleneEar loops: spandexNose clip: malleable aluminumwire/PVC | Similar |
| Dimensions | 17.5 x 9.5 cm | 17.5 x 9.5 cm | Same |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Design Features | Ear Loop | Ear loops: Polyester, polyurethaneSide tapes: Polyester spunbond (earloops mask only)Tie tapes: Polypropylene spunbond orpolyester spunbondVisor option: polyester | Different |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | White or Blue | Different |
| PerformanceClassification Standard | ASTM F2100 Level 3 | ASTM F2100 Level 1, Level 2, andLevel 3 | Different |
| Biocompatibility | |||
| Biocompatibility-CytotoxicityISO 10993-5: 2009 | Under the conditions ofthe study, the device wasnon-cytotoxic | Under the conditions ofthe study, the device wasnon-cytotoxic | Same |
| Biocompatibility-Skin IrritationISO 10993-10: 2010 | Under the conditions ofthe study, the device wasnon-irritating. | Under the conditions ofthe study, the device wasnon-irritating. | Same |
| Biocompatibility-Skin SensitizationISO 10993-10: 2010 | Under the conditions ofthe study, the device wasnon-sensitizing. | Under the conditions ofthe study, the device wasnon-sensitizing. | Same |
| Performance Testing | |||
| ASTMF2101-BacterialFiltration Efficiency(BFE) | Passed at≥99.9% ASTM F2101 | Passed at≥99.9% ASTM F2101 | Same |
| ASTMF2299-ParticulateFiltration Efficiency | >99% | 99.7% | Same |
| Differential Pressure | Passed at <6.0 mmH2O/cm2EN14683:2019 Annex C | Passed at 2.5 mmH2O/cm2 MILM-36954C | Similar |
| ASTMF1862-Fluid Resistance | Pass at 160mmHg | Pass at 160mmHg | Same |
| 16 CFR1610-Flammability | Class I | Class I | Same |
8. Technological Characteristics Comparison Table
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allmed medical products co., ltd
No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: +86-717-4211111 Fax: +86-717-4225499
Image /page/5/Picture/2 description: The image shows the logo for ALLMED. The logo consists of a stylized letter 'A' in green, with a gray plus sign above it. Below the symbol is the word "ALLMED" in gray, block letters. The logo is simple and modern, with a focus on the company name and a medical symbol.
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Image /page/6/Picture/1 description: The image shows the logo for Allmed. The logo consists of a gray triangle with a white plus sign in the center, which is stacked on top of a green stylized letter "M". The word "ALLMED" is written in gray block letters below the symbol.
The subject device is only available in one color (blue), at ASTM F2100 Level 3, only with ear loops, and with no visor option. The predicate is available in a similar configuration.
9. Biocompatibility Testing
The device was determined to be a surface-contacting device with limited duration (<24h). At the study conditions, the device was determined to be non-cytotoxic, non-irritating, and nonsensitizing. The device is biocompatible.
| Test MethodTest Identification | Purpose | ASTM F2100 Level 3 -Acceptance Criterion | Test Result |
|---|---|---|---|
| ASTM F2101-Bacterial FiltrationEfficiency | To determine the filtration efficiencyof test articles by comparing thebacterial control counts upstream ofthe test article to the bacterial countsdownstream. | ≥98%, AQL=4% | Passed |
10. Performance Testing
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allmed medical products co., ltd
No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200
Image /page/7/Picture/2 description: The image shows the logo for Allmed. The logo consists of a gray triangle on top of a green symbol that resembles a stylized letter 'M' with a plus sign in the middle. The word 'ALLMED' is written in black below the symbol.
| Tel: +86-717-4211111 | Fax: +86-717-4225499 | ALLMED | |
|---|---|---|---|
| ASTM F2299 ParticulateFiltration Efficiency | To evaluate the non-viable particlefiltration efficiency (PFE) of the testarticle. | ≥98%, AQL=4% | Passed |
| EN14683:2019 Annex CDifferential Pressure | To determine the breathability of testarticles by measuring the differentialair pressure on either side of the testarticle using a manometer, at aconstant flow rate. | <6.0 mmH2O/cm2, AQL=4% | Passed |
| ASTM F1862Fluid Resistance | To simulate surgical mask spray andevaluate the effectiveness of the testarticle in protecting the user frompossible exposure to blood and otherbody fluids. | Resistant at 160mmHg, 4% AQL | Passed |
| 16 CFR 1610Flammability | To evaluate the flammability of plainsurface clothing textiles by measuringthe ease of ignition and the speed offlame spread. | Class 1 | Passed |
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ALLMED MEDICAL PRODUCTS CO., LTD No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: +86-717-4211111 Fax: +86-717-4225499
Image /page/8/Picture/1 description: The image shows the logo for Allmed. The logo consists of a gray triangle on top, a green stylized "M" in the middle, and the word "ALLMED" in black at the bottom. The triangle has a white plus sign in the center.
The device was compared to ASTM F2100 Level 3 requirements. The device meets ASTM F2100 Level 3 performance and design criteria at the specified quality level.
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Clinical Testing Clinical testing was not performed.
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Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202128, Allmed Surgical Face Masks (Ear Loops) are 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.