K Number

Device Name

PRIMED Pediatric Facemask

Manufacturer

PRIMED Medical Products Inc.

Date Cleared

2022-11-22

(397 days)

Product Code

OXZ

Regulation Number

878.4040

Intended Use

The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.

Device Description

The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism. PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not 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

K210321, K113340

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 facemask, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as a barrier to prevent the transmission of microorganisms, body fluids, and particulate material, not to treat or cure a disease.

Diagnostic

The device is a facemask designed to provide a barrier against microorganisms, body fluids, and particulate material, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical facemask made of non-woven material, which is a hardware component.

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 device is a barrier for the respiratory tract to prevent the transmission of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description details the physical construction of the mask and its function as a barrier. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is a personal protective equipment (PPE) designed to prevent the spread of respiratory droplets.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

OXZ

Device Description

The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism.
PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

respiratory tract

Indicated Patient Age Range

4 to 12 years old

Intended User / Care Setting

patient/child in healthcare setting under an adult supervision

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)

PRIMED pediatric masks are tested to below listed standards:
ASTM F2100:2020 - Result: Meet and exceed requirement of Level 1 procedure mask
ASTM F2101: 2019 - Result: >99 %
ASTM F2299:2003 - Result: >99%
ASTM F1862: 2017 - Result: >80 mmHg
EN 14683:2019 - Result: 99%
Particulate Filtration (ASTM F2299): >99%
Differential Pressure (MIL M 3654C): 80mmHg
Flammability (16 CFR 1610): Class I
Cytotoxicity: Non-cytotoxic
Irritation: Not an irritant
Sensitization: Not a sensitizer
Migration of certain Elements (EN71-3): Pass
Total lead content: Tested under CPSC-CH-E1002-08.3 (Pass)
Phthalate Analysis: Tested under CPSC-CH-C1001-09.3 (Pass)
Sharp edge hazard: Meet the requirements of 16 CFR 1500.48 and 16 CFR 1500.49 when after simulating use and abuse of toys as per 16CFR 1500.53 (pass)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210321, K113340

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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 and 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.

November 22, 2022

PRIMED Medical Products Inc. Mitra Fard Regulatory Affairs Specialist 200, 2003-91 St. SW Edmonton, AB T6X 0W8 Canada

Re: K213427

Trade/Device Name: PRIMED Pediatric Facemask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OXZ Dated: October 26, 2022 Received: October 27, 2022

Dear Ms. Fard:

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.

Katherine D. Kavlock -S

for

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

Enclosure

Indications for Use

510(k) Number (if known) K213427

Device Name PRIMED Pediatric Facemask

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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Summary Date:	November 21, 2022
Manufacturer Information:	PRIMED Medical Products Inc.
Address:	200, 2003-91 St. SW, Edmonton, AB,
Canada, T6X 0W8
Phone Number
Fax Number
Email
Contact person:	+1.877.877.4633
+1.780.497.7670
mitra.fard@primed.ca
Mitra Fard
Common name of the device	Pediatric Facemask
Trade or Proprietary Name:	PRIMED Pediatric Facemask
Classification name for the device	Surgical Apparel
Classification regulation:
Class:	878.4040
2
Product Code:	OXZ (Pediatric/Child Facemask)
Predicate device(s)	Dukal level 1 Pediatric face mask 510(k)#: K210321
Kimberly-Clark Child's Facemask 510(k)#: K113340
Device Description	The PRIMED level 1 Pediatric Facemask is a single use, disposable
device intended to be used by patient/child 4 to 12 years old in
healthcare setting under an adult supervision to prevent the
transmission of microorganism.

Product Description:

PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.

Available Models

PG4-1680 Pediatric Mask, ASTM Level 1, Earloop, Dinosaur pattern,

Indication for Use:

| Elements of

comparison	Proposed PRIMED Pediatric mask	Primary Predicate	Secondary Predicate	Comparison
Manufacturer	PRIMED Medical Products Inc.	Kimberly-Clark	Dukal
510(k) Number	K213427	K113340	K210321
Product Code:	OXZ	OXZ	OXZ	Similar
Regulation
number	21 CFR 878.4040	21 CFR 878.4040	21 CFR 878.4040	Similar
Indication for
use	The PRIMED level 1 Pediatric
Facemask is a single use,
disposable device that is intended
to be used by patient/child 4 to 12
years old in healthcare setting
under an adult supervision to
provide a barrier for the
respiratory tract from
microorganisms, body fluids and
particulate material.	The Kimberly-Clark Pediatric/ Child
Facemask is intended to be worn by
the patient/child (recommended
ages 4-12) to provide protection for
the respiratory tract. It is a single use,
disposable device that is provided
non-sterile. This Face Mask is
recommended for use in a healthcare
selling with appropriate adult
supervision	The Dukal Level 1 Pediatric Face Masks
are intended to be worn by the
patient/child to cover the nose and
mouth to provide a barrier for the
respiratory tract from microorganisms,
body fluids, and particulate material.
Recommended ages are 4-12. The face
mask is specifically for use with patients
whose age or illness may prevent them
from taking necessary precautions in
situations where transfer of
microorganisms, body fluids, and
particulates can occur. The face masks
are recommended for use in a healthcare
setting with appropriate adult
supervision. The Dukal Level 1 Pediatric	Similar
Elements of
comparison	Proposed PRIMED Pediatric mask	Primary Predicate	Secondary Predicate	Comparison
			Face Masks are single use, disposable
devices that are provided non-sterile.
Material	Non- woven	Non-woven	Non-woven	Similar
Bacterial
Filtration
(ASTM F2101)	>99%	99.6%	>99%	Similar
Particulate
Filtration
(ASTM F2299)	>99%	98.5%	>99%	Similar
Differential
Pressure (MIL
M 3654C)	80mmHg	Not applicable	> 80mmHg	Similar
Flammability
(16 CFR 1610)	Class I	Class I	Class I	Similar
Cytotoxicity	Non-cytotoxic	Non-cytotoxic	Non-cytotoxic	Similar
Irritation	Not an irritant	Not an irritant	Not an irritant	Similar
Sensitization	Not a sensitizer	Not a sensitizer	Not a sensitizer	Similar
Migration of
certain
Elements)
EN71-3	Pass	Pass	Tested under EN 71.3	Similar
Total lead
content	Tested under CPSC-CH-E1002-08.3	Not Available	Tested under CPSC-CHE1002-08.3 &
CPSC-CH-E1001-08.3	Similar
Phthalate
Analysis	Tested under CPSC-CH-C1001-09.3	Not Available	Tested under CPSC-CHC1001-09.4	Similar
Sharp edge
hazard	Meet the requirements of 16 CFR
1500.48 and 16 CFR 1500.49 when
after simulating use and abuse of
toys as per 16CFR 1500.53	Not Available	ested under ASTM F963-17 (sec. 4.6, 4.7,
and 4.9), 16 CFR Part 1500, 16 CFR Part
1501	Similar
Mask
construction
and
technological
features	PRIMED Pediatric Child mask is
generally composed of a filter
layer that is ultrasonically bonded
between layers of nonwoven
fabric. This mask is appropriately
sized to the smaller faces of
children between ages of 4 to 12
years old. The PRIMED single use,
non-sterile Pediatric/Child
Facemask meet requirements of
level 1 masks as per ASTM F2100.
All of materials used in this device
are typical materials commonly
used in the construction of legally
marketed surgical masks with a
safe history of use. The masks are	The Kimberly-Clark Pediatric/Child
Facemask is a three layer mask,
constructed of nonwoven polyester
blends and polypropylene materials.
Bindings are nonwoven polyester
and earloops are knitted
polyester/lycra. A malleable
nosepiece is placed within the
bindings for comfort and
individualized fit around the
wearer's nose. The Pediatric/Child
Facemask is appropriately sized to
the smaller faces of children across a
diverse population. The
Pediatric/Child Facemask is a single
use, disposable device, provided
non-sterile.	The Dukal Level 1 Pediatric Face Mask is
manufactured using ultrasonic hot
sealing, composed of three layers of
materials and pleated to form the mask.
The inner layer is composed of
Polypropylene (Spunbond), the middle
layer is Polypropylene (Meltblown) filter
material, and the outer layer is
polypropylene (Spunbond). Decorative
patterns are printed with colored inks.
Masks are held in place on wearer with
polyester/spandex elastic earloop and
contain a malleable aluminum wire nose
piece. The Pediatric/Child's Face Mask is
appropriately sized to the smaller faces
of children across a diverse population.
All of the materials used in this device	Similar
Elements
of
comparison	Proposed PRIMED Pediatric mask	Primary Predicate	Secondary Predicate	Comparison
	not made with natural rubber
latex.		are typical materials commonly used in
the construction of Surgical Masks and
are being used in current legally
marketed devices. This product is not
made with natural rubber latex.
Anthropometry	Based on an anthropometric study
sample that is representative of
the US population in both gender
and racial distribution, the Dukal
Level 1 Pediatric Face Mask will
provide adequate coverage to
children 4 to 12 years old with face
width of 8.5 to 12.8 cm and lower
face length of 8.5 to 11.4 cm	Not available	Based on an anthropometric study
sample that is representative of the US
population in both gender and racial
distribution, the Dukal Level 1 Pediatric
Face Mask will provide adequate
coverage to children between the ages
of 4-12 years old of weight between 25-
176 pounds, and of height between
3′00″ — 5′08″".	Similar

Summary of the Technological Characteristics of PRIMED Pediatric Facemask and the predicate

510(k) Summary

Summary of Testing:

PRIMED pediatric masks are tested to below listed standards:

Standard		Result
ASTM F2100:2020	Standard Specification for Performance of Materials
Used in Medical Face Masks	Meet and exceed requirement
of Level 1 procedure mask
ASTM F2101: 2019	Standard Test Method for Evaluating the Bacterial
Filtration Efficiency (BFE) of Medical Face Mask
Materials, Using a Biological Aerosol of Staphylococcus
aureus	>99 %
ASTM F2299:2003	Test Method for Determining the Initial Efficiency of
Materials Used in Medical Face Masks to Penetration by
Particulates Using Latex Spheres	>99%
ASTM F1862: 2017	Standard Test Method for Resistance of Medical Face
Masks to Penetration by Synthetic Blood	>80 mmHg
EN 14683:2019	Medical Face Masks—Requirements and Test Methods:
Determine breathing resistance or differential pressure
as directed in EN 14683:2019, Annex C.