Allmed Surgical Face Masks (Ear loops)

K202128 · Allmed Medical Products Co., Ltd. · FXX · Jun 3, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202128
• Device Name: Allmed Surgical Face Masks (Ear loops)
• Applicant: Allmed Medical Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

Allmed Surgical Face Mask is a 3-layer, flat-pleated, single-use, disposable device; worn by healthcare workers and patients to provide a barrier against microorganisms, body fluids, and particulates. Construction includes outer/inner polypropylene spunbond layers and a central polypropylene meltblown filter layer; secured via spandex/polyester ear loops; includes malleable iron wire nosepiece for fit. Device is non-sterile. Used in clinical settings for infection control; provides protection against fluid exposure up to 160 mmHg. Benefits include reduced risk of cross-contamination and exposure to blood/body fluids during surgical or clinical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100 Level 3 criteria: Bacterial Filtration Efficiency (BFE) ≥99.9% (ASTM F2101), Particulate Filtration Efficiency (PFE) >99% (ASTM F2299), Differential Pressure <6.0 mmH2O/cm2 (EN14683), Fluid Resistance 160 mmHg (ASTM F1862), and Flammability Class I (16 CFR 1610). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

3-layer construction: polypropylene spunbond outer/inner layers, polypropylene meltblown filter. Ear loops: spandex/polyester. Nosepiece: malleable iron wire with plastic/polypropylene cover. Dimensions: 17.5 x 9.5 cm. Flat-pleated design. Non-sterile. Meets ASTM F2100 Level 3 performance standards.

Indications for Use

Indicated for patients and healthcare workers to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Face Masks (Ear loops and Tie-on) (K160269)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{3}------------------------------------------------

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: [phone] |
| | Fax: [phone] |

| 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. |

{4}------------------------------------------------

ALLMED MEDICAL PRODUCTS CO., LTD

No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: [phone] Fax: [phone]

- 6. 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.
- 7. 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 of<br>Comparison | Subject Device | Predicate Device | Comparison |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K202128 | K160269 | |
| Trade Name | Allmed Surgical Face Masks<br>(Ear Loops) | Surgical Face Masks (Ear loops<br>and Tie-on) | |
| Manufacturer | ALLMED MEDICAL PRODUCTS CO.,<br>LTD | SAN-M PACKAGE CO., LTD. | |
| General | | | |
| Indications for Use | Allmed Surgical Face Masks(Ear<br>Loops) are intended to be worn<br>to protect both patients and<br>healthcare workers from transfer<br>of microorganisms, body fluids,<br>and particulate material. The<br>surgical face mask is intended for<br>use in infection control practices<br>to reduce the potential exposure | The surgical mask is intended to be<br>worn to protect both patients and<br>healthcare workers from transfer of<br>microorganisms, body fluids, and<br>particulate material. The surgical<br>mask is intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. The surgical mask is a | Same |
| | to blood and body fluids. The<br>surgical face mask is a single use,<br>disposable device provided<br>non-sterile. | single use, disposable device<br>provided<br>non-sterile. | |
| Material Composition | Three-layer mask constructed of:<br>Outer layer: Polypropylene<br>Spunbond<br>Filter layer: Polypropylene<br>Meltblown<br>Inner layer: Polypropylene<br>Spunbond<br>Ear loops: Spandex elastic,<br>polyester<br>Nose Piece: Malleable Iron wire<br>with plastic cover/Polypropylene | Three-layer mask constructed of:<br>Outer layer: spunbond<br>polypropylene<br>Filter layer: meltblown<br>polypropylene<br>Inner layer: spunbond polypropylene<br>Ear loops: spandex<br>Nose clip: malleable aluminum<br>wire/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, polyurethane<br>Side tapes: Polyester spunbond (ear<br>loops mask only)<br>Tie tapes: Polypropylene spunbond or<br>polyester spunbond<br>Visor option: polyester | Different |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | White or Blue | Different |
| Performance<br>Classification Standard | ASTM F2100 Level 3 | ASTM F2100 Level 1, Level 2, and<br>Level 3 | Different |
| Biocompatibility | | | |
| Biocompatibility-<br>Cytotoxicity<br>ISO 10993-5: 2009 | Under the conditions of<br>the study, the device was<br>non-cytotoxic | Under the conditions of<br>the study, the device was<br>non-cytotoxic | Same |
| Biocompatibility-<br>Skin Irritation<br>ISO 10993-10: 2010 | Under the conditions of<br>the study, the device was<br>non-irritating. | Under the conditions of<br>the study, the device was<br>non-irritating. | Same |
| Biocompatibility-<br>Skin Sensitization<br>ISO 10993-10: 2010 | Under the conditions of<br>the study, the device was<br>non-sensitizing. | Under the conditions of<br>the study, the device was<br>non-sensitizing. | Same |
| Performance Testing | | | |
| ASTM<br>F2101-Bacterial<br>Filtration Efficiency<br>(BFE) | Passed at≥99.9% ASTM F2101 | Passed at≥99.9% ASTM F2101 | Same |
| ASTM<br>F2299-Particulate<br>Filtration Efficiency | >99% | 99.7% | Same |
| Differential Pressure | Passed at <6.0 mmH2O/cm2<br>EN14683:2019 Annex C | Passed at 2.5 mmH2O/cm2 MILM-<br>36954C | Similar |
| ASTM<br>F1862-Fluid Resistance | Pass at 160mmHg | Pass at 160mmHg | Same |
| 16 CFR<br>1610-Flammability | Class I | Class I | Same |

### 8. Technological Characteristics Comparison Table

{5}------------------------------------------------

# allmed medical products co., ltd

No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: [phone] Fax: [phone]

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.

{6}------------------------------------------------

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 Method<br>Test Identification | Purpose | ASTM F2100 Level 3 -<br>Acceptance Criterion | Test Result |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------|
| ASTM F2101-<br>Bacterial Filtration<br>Efficiency | To determine the filtration efficiency<br>of test articles by comparing the<br>bacterial control counts upstream of<br>the test article to the bacterial counts<br>downstream. | ≥98%, AQL=4% | Passed |

#### 10. Performance Testing

{7}------------------------------------------------

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: [phone] | Fax: [phone] | ALLMED | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------|
| ASTM F2299 Particulate<br>Filtration Efficiency | To evaluate the non-viable particle<br>filtration efficiency (PFE) of the test<br>article. | ≥98%, AQL=4% | Passed |
| EN14683:2019 Annex C<br>Differential Pressure | To determine the breathability of test<br>articles by measuring the differential<br>air pressure on either side of the test<br>article using a manometer, at a<br>constant flow rate. | <6.0 mmH2O/cm2, AQL=4% | Passed |
| ASTM F1862<br>Fluid Resistance | To simulate surgical mask spray and<br>evaluate the effectiveness of the test<br>article in protecting the user from<br>possible exposure to blood and other<br>body fluids. | Resistant at 160mmHg, 4% AQL | Passed |
| 16 CFR 1610<br>Flammability | To evaluate the flammability of plain<br>surface clothing textiles by measuring<br>the ease of ignition and the speed of<br>flame spread. | Class 1 | Passed |

{8}------------------------------------------------

ALLMED MEDICAL PRODUCTS CO., LTD No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province, China 443200 Tel: [phone] Fax: [phone]

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.

11. Clinical Testing Clinical testing was not performed.

12. 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.