K Number

Device Name

Topwide Surgical Face Mask

Manufacturer

Topwide (Hubei) Medical Products Manufacturer

Date Cleared

2021-12-17

(337 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

Device Description

The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non sterile. This product contains no components made with natural rubber latex.

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

K201691

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.

Therapeutic

No.
The device description and intended use clearly state that it is a surgical face mask designed to protect against the transfer of microorganisms, body fluids, and particulate material, which is a preventive measure rather than a therapeutic treatment.

Diagnostic

The device description indicates it is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its purpose is for infection control, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (polypropylene spunbond, melt-blown filter, ear-loops, nosepiece) and performance testing related to material properties and physical resistance, indicating it is a hardware device.

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 both patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
Device Description: The description details the physical construction and materials of a surgical mask. There is no mention of components or functions related to analyzing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, pressure differential, biocompatibility). These are relevant to a protective device, not a diagnostic one.
Key Metrics: The key metrics are measurements of the mask's physical performance as a barrier, not diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV in the context of diagnosing a disease.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TOPWIDE surgical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the posure to blood and body fluids. This device is non-sterile and for single use only.

Product codes (comma separated list FDA assigned to the subject device)

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

healthcare personnel

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)

Following performance data has been provided from 3 nonconsecutive lots to demonstrate that the subject device meet the acceptance criteria the standard.
Test Methodology, Standard: ASTM F1862; Purpose: Resistance to penetration by synthetic blood; Acceptance Criteria: 120 mm Hg; Results: 120 mm Hg
Test Methodology, Standard: ASTM F2299; Purpose: Particulate filtration efficiency; Acceptance Criteria: ≥ 98%; Results: >99%
Test Methodology, Standard: ASTM F2101; Purpose: Bacterial filtration; Acceptance Criteria: ≥ 98%; Results: ≥ 98%
Test Methodology, Standard: 16 CFR 1610; Purpose: Flammability; Acceptance Criteria: Class 1; Results: Class 1
Test Methodology, Standard: ASTM F2100; Purpose: Differential Pressure (Delta-P); Acceptance Criteria:

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 17, 2021

Topwide Medical Products Manufacturer % Jimmy Wu Associate Lee and Xiao 2600 Mission Street, Suite 206 San Marino, California 91108

Re: K210102

Trade/Device Name: Topwide Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: General Hospital Regulatory Class: Class II Product Code: FXX Dated: October 30, 2021 Received: November 3, 2021

Dear Jimmy Wu:

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 (QS) 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,

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

Indications for Use

510(k) Number (if known)

K210102

Device Name TOPWIDE SURGICAL FACE MASK

Indications for Use (Describe)

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 K210102

1. Type of 510(k) submission:	Traditional	Submitted on:	12/13/2021
2. Device Type:	Mask, Surgical
3. 510(k) Submitter/Owner:
Name:	Topwide (Hubei) Medical Products Manufacturer
Address:	19 Xianhong Road, Xin Li Ren Kou
Xiantao, Hubei 433012
CHINA
Phone:	86-728-2714000	Fax:	86-728-2712999
Contact:	Jimmy Wu	Email:	JWU@LEEXIAO.COM
4. Device:
Common Name:	Surgical Face Mask
Trade Name:	Topwide Surgical Face Mask

CFR Section: Product Classification: Classification Panel: Product Code:

21 CFR 878.4040 Class II General Hospital FXX

1. Basis for the Submission: New Device
Predicate Device: Single-Use Surgical Mask with Ear Loop (K201691) 6.

7. Indication For Use:

The TOPWIDE surqical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

8. Device Description:

sterile.

This product contains no components made with natural rubber latex.

	Subject Device - Topwide	Predicate Device - Single-Use
	Surgical Face Mask	Surgical Mask with Ear Loop
Device	(K210102)	(K201691)	Comparison
	The TOPWIDE surgical face mask	The Single-Use Surgical Mask
	is intended to be worn to	with Ear Loop is intended to be
	protect both patient and	worn to protect both the
	healthcare personnel from	patient and healthcare
	transfer of microorganisms,	personnel from the transfer of
	body fluids and particulate	microorganisms, body fluids,
	material. The TOPWIDE surgical	and particulate material. The
Intended Use	intended for use in infection	Single-Use Surgical Mask with	Same
	control practices to reduce the	Ear Loop intended for use in
	potential exposure to blood and	infection control practices to
	body fluids. This device is non-	reduce the potential exposure
	sterile and for single use only.	to blood and body fluids. This is
		a single-use, disposable
		device(s), provided non-sterile.
		Model: M and L, blue color, and
		Level
		2 barrier level as ASTM F2100.
Design feature
	Spun-bond polypropylene
Outer layer		Spun-bond polypropylene
	Melt blown
Middle layer	polypropylene	Melt blown non-woven fabric	SAME
	Spun-bond polypropylene
Inner layer		Spun-bond polypropylene
	Wire, malleable nosepiece,
	plastic-	Wire, malleable aluminum	DIFFERENT
Nose piece	coated steel	nosepiece
	Polyester and spandex
Ear Loops	materials	Polyester	SAME

			DIFFERENT
Color	White outer layer	Blue
Mask style	Flat pleated, Ear-	Flat pleated, Ear-Loop	SAME
	Loop
Length: 17.5 cm ± 0.5 cm, Width:
Size	9.5 cm ±	Large: Length - 18 cm ± 1 cm, Width	DIFFERENT
	0.5 cm	9 cm
± 1 cm
Single Use	ત્વની દિવેલા તાલુકામાં આવેલું એક ગામ છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગના અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને	Yes
OTC Use	yes	Yes	SAME
Sterile	Non-Sterile	Non-Sterile

9. Technological Characteristic Comparison

Performance
ASTM F2100
Level	II	II	SAME
Fluid resistance
(ASTM F1862)	32 out of 32 pass at
16Kpa (120 mmHg)	31 out of 32 pass at 120 mmHg
Particulate
Filtration (ASTM
F2299)	$\ge$ 99.78%	> 99%	SIMILAR
Bacterial Filtration
(ASTM F2101)	$\ge$ 98%	> 99%
Differential
Pressure (Delta-P)
(ASTM F2100)	99%
ASTM F2101	Bacterial filtration	≥ 98%	≥ 98%
16 CFR 1610	Flammability	Class 1	Class 1
ASTM F2100	Differential Pressure
(Delta-P)