K Number

Device Name

Procedure Mask with Ear Loops and Surgical Mask with Ties

Manufacturer

SafeSource Direct, LLC

Date Cleared

2022-05-19

(30 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile. The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

Device Description

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose. The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

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

K202899

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 standard surgical/procedure mask. There is no mention of any computational or analytical functions that would utilize AI/ML.

Therapeutic

No.

The device is intended for protection against the transfer of microorganisms, bodily fluids, and particulate material, and for infection control, it does not treat or cure a disease or condition.

Diagnostic

Explanation: The device is a surgical/procedure mask intended to protect against the transfer of microorganisms and bodily fluids. Its purpose is to act as a barrier, not to diagnose any condition or disease.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (spunbond polypropylene, meltblown polypropylene, ear loops, nose wire, tie straps) and the testing performed relates to the physical properties and performance of these materials and the assembled mask, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Intended Use: The intended use of these masks is to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description details the physical construction of the masks, not any components or processes related to analyzing biological samples.
Performance Studies: The performance studies focus on the physical properties of the masks (filtration efficiency, fluid resistance, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.

The purpose of these masks is to prevent the spread of contaminants, which is a crucial aspect of infection control, but it does not involve the in vitro examination of biological specimens for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

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

FXX

Device Description

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

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)

Non-clinical testing was conducted to verify the proposed device meets the same design specifications as the predicate device. Test results demonstrated the proposed device complies with the requirements of US FDA Guidance for Industry and FDA Staff / Surgical Masks - Premarket Notification [510(k)] Submissions posted on July 14, 2004 and the following standards:

ASTM F2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks
ASTM F2101-19, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus aureus
EN 14683:2019 + AC:2019 Annex C, Medical Face Masks-Requirements and Test Methods
ASTM F2299/F2299M-03(2017), Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F1862/F1862M-17, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
16 CFR 1610, Standard for the Flammability of Clothing Textiles
ISO 10993-5: 2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity, and
ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.

Key results:
ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001)

Fluid Resistance: Pass (96/96) at 80 mmHg, 32 samples from 3 non-consecutive lots
Particulate Filtration Efficiency: Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots
Bacterial Filtration Efficiency: Pass (96/96) at > 95%, 32 samples from 3 non-consecutive lots
Differential Pressure: Pass (96/96) at 98%, 32 samples from 3 non-consecutive lots
Bacterial Filtration Efficiency: Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots
Differential Pressure: Pass (96/96) 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 19, 2022

SafeSource Direct, LLC % Prithul Bom Most Repsonsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K221134

Trade/Device Name: Procedure Mask with Ear Loops and Surgical Mask with Ties Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 18, 2022 Received: April 19, 2022

Dear Prithul Bom:

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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K221134

Device Name

Procedure Mask with Ear Loops and Surgical Mask with Ties

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)

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 PRAStaff(@fda.hhs.gov

"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."

510(k) Summary

Version: 2

K221134

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

Submitter Information

Company:	Robbie Wicks
	Vice President / COO
	SafeSource Direct, LLC
	200 St Nazaire Rd.
	Broussard, LA 70518 United States
	Telephone: 337-210-7943
	Fax: 337-202-8099
	rwicks@safesourcedirect.com)
Contact:	Robbie Wicks
	Vice President / COO
	SafeSource Direct, LLC
	200 St Nazaire Rd.
	Broussard, LA 70518 United States
	Telephone: 337-210-7943
	Fax: 337-202-8099
	rwicks@safesourcedirect.com)
Date Summary Prepared:	April 12, 2022
Trade Name:	Procedure Mask with Ear Loops and Surgical Mask
with Ties
Common Name:	Mask, surgical
Classification Name:	Surgical apparel
Review Panel:	General & Plastic Surgery (SU)
Regulation:	878.4040
Class:	Class II
Product Code:	FXX

Equivalence Claimed to Predicate Device

The Procedure Mask with Ear Loops and Surgical Mask with Ties is equivalent to the Procedure Mask, Surgical Mask (K202899), manufactured by Kenpax International Limited.

Trade Name:	Procedure Mask / Surgical Mask
Common Name:	Surgical Mask
Classification Name:	Surgical Face Mask
Product Code:	FXX

Device Description

Substantial Equivalence Table
Characteristic	Proposed Device: Procedure
Mask with Ear Loops and
Surgical Mask with Ties	Primary Predicate Device:
Procedure Mask, Surgical Mask
(K202899)
Intended Use	To protect both patients and
healthcare personnel from the
transfer of microorganisms, body
fluids, and particulate material.	To protect both patients and
healthcare personnel from the
transfer of microorganisms, body
fluids, and particulate material.
Indication for Use	The SafeSource Direct Procedure
Mask with Ear Loops is intended to
be worn to protect both the patient
and healthcare personnel from the
transfer of microorganisms, bodily
fluids, and particulate material.
These procedure masks are
intended for use in infection
control practices to reduce the
potential exposure to blood and
bodily fluid. The procedure masks
are single use, disposable devices,
provided non-sterile.
The SafeSource Direct Surgical
Mask with Ties is intended to be
worn to protect both the patient and
healthcare personnel from the
transfer of microorganisms, bodily
fluids, and particulate material.
These surgical masks are intended
for use in infection control
practices to reduce the potential
exposure to blood and bodily fluid.
The surgical masks are single use,
disposable devices, provided non-	The Procedure Masks/ 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.
	sterile.
510(k) No.	Pending	K202899
Manufacturer	SafeSource Direct, LLC	Kenpax International Limited
Classification	Class II, FXX (21 CFR 878.4040)	Class II, FXX (21 CFR 878.4040)
Model Description	PM3001: Procedure Mask with Ear
Loops, ASTM Level 1
PM3003: Procedure Mask with Ear
Loops, ASTM Level 3
SM3001: Surgical Mask with Ties,
ASTM Level 1
SM3003: Surgical Mask with Ties,
ASTM Level 3	68-8506-G: Procedure Mask,
Earloop, ASTM Level 1
65-8508-G: Procedure Mask,
Earloop, ASTM Level 3
68-8536-B: Surgical Mask, Tie-on,
ASTM Level 1
68-8538-B: Surgical Mask, Tie-on,
ASTM Level 3
Design Features	Ear Loops, Tie-on	Ear Loops, Tie-on
Mask Style	Flat Pleated	Flat Pleated
Outer Facing Layer	Blue spunbond (polypropylene)
Level 1: 25 gsm
Level 3: 25 gsm	Spunbond polypropylene
Level 1: 22 gsm
Level 3: 25 gsm
Middle Layer	White meltblown (polypropylene)
Level 1: 25 gsm
Level 3: 25 gsm	Melt-blown polypropylene
Level 1: 22 gsm
Level 3: 25 gsm
Inner Facing Layer	Blue spunbond (polypropylene)
Level 1: 25 gsm
Level 3: 25 gsm	Spunbond polypropylene
Level 1: 22 gsm
Level 3: 25 gsm
Nose Piece	Dual aluminum wire, white
ethylene propylene copolymer	Polyethylene coated steel wire
Ear Loops	White knitted spandex/elastane
fiber, polyester filament	Nylon, spandex
Tie-On	White spunbond (polypropylene)	Spunbond polypropylene
Color	Blue, White	Blue, Green
Dimension (Width)	3.74" ± 0.40"	95 ± 5 mm
Dimension (Length)	6.89" ± 0.40"	178 ± 5 mm
OTC Use	Yes	Yes
Sterility	Non-sterile	Non-sterile
Use	Single Use, Disposable	Single Use, Disposable
ASTM F2100 Level	Level 1, Level 3	Level 1, Level 3
Fluid Resistance	Meet ASTM F1862/F1862M-17	Meet ASTM F1862-17
Particulate Filtration Efficiency
(PFE)	Meet ASTM F2299/F2299M-03
(2017)	Meet ASTM F2299-17
Bacterial Filtration
(BFE)	Efficiency
	Meet ASTM F2101-19	Meet ASTM F2101-19
Differential Pressure	Meet EN 14683:2019+AC:2019
Annex C	Meet EN 14683:2019, Annex C
Flammability	Meet 16 CFR 1610 (Oct 2008)	Meet 16 CFR 1610
Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Irritation	Negligibly irritating (Primary
Irritation Index 0.0)	Non-irritating
Sensitization	Not a contact sensitizer	Non-sensitizing

Substantial Equivalence Comparison

K221134

Page 3 of 6

Additional Information

Summary of Non-Clinical Testing Conducted

· ASTM F2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks
· ASTM F2101-19, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus aureus
· EN 14683:2019 + AC:2019 Annex C, Medical Face Masks-Requirements and Test Methods
· ASTM F2299/F2299M-03(2017), Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
· ASTM F1862/F1862M-17, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
· 16 CFR 1610, Standard for the Flammability of Clothing Textiles
· ISO 10993-5: 2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity, and
· ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.

Tables 1 and 2 summarize the performance test data.

| Table 1 Comparison of Performance Testing for Proposed ASTM Level 1 Procedure

Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate
Device
Non-Clinical
Test	Acceptance
Criteria
(ASTM
Level 1)	Proposed
Device	Predicate
Device
(K202899)	Proposed
Device	Predicate
Device
(K202899)
		PM3001	68-8506-G	SM3001	68-8536-B

K221134 Page 5 of 6

| Fluid
Resistance | ≥ 29 of 32
pass at 80
mmHg | Pass (96/96)
at 80 mmHg,
32 samples
from 3 non-
consecutive
lots | 32 of 32
passed at 80
mmHg, 3 lots | Pass (96/96)
at 80 mmHg,
32 samples
from 3 non-
consecutive
lots | 32 of 32
passed at 80
mmHg, 3 lots |
|-----------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------|
| Particulate
Filtration
Efficiency | ≥ 95% at 0.1
micron | Pass (96/96)
at > 95%,
32 samples
from 3 non-
consecutive
lots | 97.4%,
97.5%,
97.5% | Pass (96/96)
at > 95%,
32 samples
from 3 non-
consecutive
lots | 97.2%,
97.1%,
97.1% |
| Bacterial
Filtration
Efficiency | ≥ 95% | Pass (96/96)
at > 95%, 32
samples from
3 non-
consecutive
lots | 99.9%, 3 lots | Pass (96/96)
at > 95%, 32
samples from
3 non-
consecutive
lots | 99.9%, 3 lots |
| Differential
Pressure | 98%, 32 samples from 3 non-consecutive lots | 98.2%, 98.4%, 98.4% | Pass (95/96) at > 98%, 32 samples from 3 non-consecutive lots | 98.4%, 98.4%, 98.3% |
| Bacterial Filtration Efficiency | ≥ 98% | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots | 99.9%, 3 lots | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots | 99.9%, 3 lots |
| Differential Pressure |