K Number

Device Name

Allmed Surgical Face Masks (Ear loops)

Manufacturer

Allmed Medical Products Co., LTD

Date Cleared

2021-06-03

(307 days)

Product Code

FXX

Regulation Number

878.4040

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K160269

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.

Therapeutic

No
The device, a surgical face mask, is intended for infection control by creating a physical barrier to microorganisms and body fluids. It does not exert any direct therapeutic effect on a disease or condition.

Diagnostic

The device is a surgical face mask, intended to protect against the transfer of microorganisms and fluids, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a physical surgical face mask made of multiple layers of material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on filtration efficiency, fluid resistance, and flammability – metrics relevant to a barrier device, not a diagnostic one.
Predicate Device: The predicate device is also a surgical face mask, reinforcing its classification as a protective barrier.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing
ASTM F2101-Bacterial Filtration Efficiency (BFE): Passed at >=99.9% ASTM F2101
ASTM F2299-Particulate Filtration Efficiency: >99%
Differential Pressure: Passed at

Regulation Number and Section

§ 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.

Summary

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

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

Indications for Use

510(k) Number (if known) K202128

Device Name Allmed Surgical Face Masks (Ear Loops)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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.

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

1. 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.
1. 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

Comparison	Subject Device	Predicate Device	Comparison
510(k) Number	K202128	K160269
Trade Name	Allmed Surgical Face Masks
(Ear Loops)	Surgical Face Masks (Ear loops
and Tie-on)
Manufacturer	ALLMED MEDICAL PRODUCTS CO.,
LTD	SAN-M PACKAGE CO., LTD.
General
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	The surgical mask is intended to be
worn to protect both patients and
healthcare workers from transfer of
microorganisms, body fluids, and
particulate material. The surgical
mask is intended for use in infection
control practices to reduce the
potential exposure to blood and
body fluids. The surgical mask is a	Same
	to blood and body fluids. The
surgical face mask is a single use,
disposable device provided
non-sterile.	single use, disposable device
provided
non-sterile.
Material Composition	Three-layer mask constructed of:
Outer layer: Polypropylene
Spunbond
Filter layer: Polypropylene
Meltblown
Inner layer: Polypropylene
Spunbond
Ear loops: Spandex elastic,
polyester
Nose Piece: Malleable Iron wire
with plastic cover/Polypropylene	Three-layer mask constructed of:
Outer layer: spunbond
polypropylene
Filter layer: meltblown
polypropylene
Inner layer: spunbond polypropylene
Ear loops: spandex
Nose clip: malleable aluminum
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
Side tapes: Polyester spunbond (ear
loops mask only)
Tie tapes: Polypropylene spunbond or
polyester spunbond
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
Classification Standard	ASTM F2100 Level 3	ASTM F2100 Level 1, Level 2, and
Level 3	Different
Biocompatibility
Biocompatibility-
Cytotoxicity
ISO 10993-5: 2009	Under the conditions of
the study, the device was
non-cytotoxic	Under the conditions of
the study, the device was
non-cytotoxic	Same
Biocompatibility-
Skin Irritation
ISO 10993-10: 2010	Under the conditions of
the study, the device was
non-irritating.	Under the conditions of
the study, the device was
non-irritating.	Same
Biocompatibility-
Skin Sensitization
ISO 10993-10: 2010	Under the conditions of
the study, the device was
non-sensitizing.	Under the conditions of
the study, the device was
non-sensitizing.	Same
Performance Testing
ASTM
F2101-Bacterial
Filtration Efficiency
(BFE)	Passed at≥99.9% ASTM F2101	Passed at≥99.9% ASTM F2101	Same
ASTM
F2299-Particulate
Filtration Efficiency	>99%	99.7%	Same
Differential Pressure	Passed at