(165 days)
No
The document describes a standard surgical mask and its performance characteristics based on material properties and filtration efficiency, with no mention of AI or ML.
No
A therapeutic device is used to treat a disease or condition. This surgical mask is intended to protect against the transfer of microorganisms and body fluids, which is a preventive function, not a therapeutic one.
No
Explanation: The device is a surgical mask intended for protection against microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (three-layers of polypropylene, ear loops, malleable nosepiece) and performance testing related to material properties and physical filtration, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical mask is for protecting individuals from the transfer 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 and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
- Performance Studies and Metrics: The performance studies and metrics listed (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility) are all related to the physical barrier and safety properties of the mask, not to diagnostic accuracy or performance.
In summary, the surgical mask is a personal protective equipment (PPE) device designed to prevent the transmission of infectious agents through physical means. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
The device is not made from Natural Rubber Latex.
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 within infection control practices
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
Non-Clinical Performance Testing: The surgical mask was tested according to ASTM 2100-19 and met the requirements for ASTM Level 2 or Level 3 and biocompatibility.
Performance Characteristics, Level 2, 3:
- ASTM F1862-17 (Resistance to Penetration by Synthetic Blood): Passed
- ASTM F2299 (Particulate Filtration Efficiency (PFE)): Passed
- ASTM F2101-19 (Bacterial Filtration Efficiency (BFE)): Passed
- EN 14683:2019 Annex C (Differential Pressure): Passed
- 16 CFR Part 1610 (Flammability of Clothing Textiles): Passed
- ISO10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process): Met the requirements
- ISO10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity): No cytotoxicity or cell lysis was noted.
- ISO10993-10 (Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Sensitization, 1ed): No evidence of sensitization or irritation was observed
Clinical Performance: No Clinical study is included in this submission.
Key results: The devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device, K160269.
Key Metrics
- Fluid Resistance (ASTM F1862-17): Pass @ 120 mmHg (Level 2), Pass @ 160 mmHg (Level 3)
- Particulate Filtration Efficiency (PFE) (ASTM F2299): Pass @ 99.8% (Level 2), Pass @ 99.8% (Level 3)
- Bacterial Filtration Efficiency (BFE) (ASTM F2101-19): Pass @ >99% (Level 2), Pass @ >99% (Level 3)
- Differential Pressure (EN 14683:2019 Annex C): Pass @ 5.1mm H₂0/cm² (Level 2), Pass @ 5.1mm H₂0/cm² (Level 3)
- Flammability (16 CFR Part 1610): Class 1 (Level 2 & 3)
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
Predicate Device(s)
San-M Package Co, K160269 Surgical Mask
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 23, 2021
Plastikon Industries % Mary Gallup RA Consultant Hantel Technologies, Inc 3496 Breakwater Ct Hayward, California 94545
Re: K203064
Trade/Device Name: Surgical Mask, ASTM Level 2 or Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 12, 2021 Received: February 17, 2021
Dear Mary Gallup:
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.
1
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 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.
Ryan Ortega, 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) K203064
Device Name Surgical Mask, ASTM Level 2 or Level 3
Indications for Use (Describe)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
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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3
510(k) Summary - K203064
| Device Name: | Surgical Mask, ASTM Level 2 or Level 3 |
|---|---|
| Sponsor Information: | Plastikon Industries |
| 688 Sandoval Way | |
| Hayward, CA 94545 | |
| Contact person: | Paul Gutwald |
| Title: Chief Operating Officer | |
| Phone Number: (510) 400-1010 | |
| Fax Number: (510) 400-1141 | |
| e-mail: pgutwald@plastikon.com | |
| Date of Summary: | 03/15/2021 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Proprietary Name: | Surgical Mask - ASTM Level 2 or Level 3 |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per (21 CFR §878.4040) |
| Predicate Device: | San-M Package Co, K160269 Surgical Mask |
| Intended Use: | The Surgical Mask is 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 potential exposure to blood and body fluids. The face | |
| mask is single use, disposable device, provided non-sterile. |
Available Model Numbers
PLASMA Surgical-1 Surgical Mask
Device Description:
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
The device is not made from Natural Rubber Latex.
4
Technological Characteristics:
The Surgical Mask is compared with the predicate device. The results are shown below in the Technological Characteristics Comparison Table:
| Items(S) | Surgical Mask (K203064)
Subject Device | | Predicate Device (K160269)
San-M Package Co.
Surgical Face Masks | | | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Intended Use/
Indications for
Use | The surgical mask is intended
to be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body fluids,
and particulate material. This
face mask is intended for use
in infection control practices to
reduce potential exposure to
blood and body fluids. This is
a single-use, disposable
device, provided non-sterile. | | The surgical face 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 potential exposure to
blood and body fluids. This is
a single-use, disposable
device, provided non-sterile. | | | Same |
| | Materials | | | | | |
| Outer Material | Polypropylene Spunbond,
White | | Polypropylene | | | Same |
| Filter Web
(Middle) | Polypropylene Meltblown,
white | | 1. Polypropylene
spunbond
2. Polypropylene
meltblown | | | Same |
| Inner Material | Polypropylene Spunbond,
white | | Polypropylene | | | Same |
| Nose Clamp | Polyethylene Coated Steel
Wire | | Polyethylene coated steel wire | | | Same |
| Ear Loops / Tie
Tapes | Elastic Laminate –
No Tie Tapes | | Ear loops: Polyester,
polyurethane
Side tapes:
Polyester spunbond (ear loops
mask only)
Tie tapes:
Polypropylene spunbond or
polyester spunbond | | | Same – The
subject device
is an ear loop
type
attachment.
The ear loop
materials has
been tested for
biocompatibility
and does not
does not affect
the device
performance. |
| | Design Features | | | | | |
| Colors | White (Outer) | | Colors: white or blueVisor option: polyester | | | Different
The subject
device does not |
5
| Style | Flat - Pleated | Flat - Pleated | come in any other colors. The color of the device does not affect the device performance or Biocompatibility as demonstrated by the test results. |
|---|---|---|---|
| Multiple Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions | |||
| Length | $95 \pm 19mm$ | $90 \pm 3mm$ | Same |
| Width | $175 \pm 19mm$ | $175 \pm 5mm$ | Same |
| Performance Testing (ASTM F2100) | Subject Device
Level 2 Level 3 | Predicate Device
Level 1 Level 2 Level 3 | Comparison |
| ---------------------------------- | ----------------------------------- | --------------------------------------------- | ------------ |
|---|
| Fluid
Resistance
ASTM F1862-
17 | Pass @
120
mmHg | Pass @
160
mmHg | Pass @
80
mmHg | Pass @
120
mmHg | Pass @
160
mmHg | Same |
|---------------------------------------------------------------------|-----------------------|-----------------------|----------------------|-----------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Particulate
Filtration
Efficiency
(PFE)
ASTM F2299 | Pass @
99.8% | Pass @
99.8% | Pass @
99.6% | Pass @
99.6% | Pass@
99.7% | Different
The subject
device has
slightly higher
or improved
particulate
efficiency. This
does not
increase risk
associated
with the use of
the device |
| Bacterial
Filtration
Efficiency
(BFE)
ASTM F2101-
19 | Pass @
99% | Pass @
99% | Pass @
98% | Pass @
98% | Pass @
98% | Different
The subject
device has
slightly higher
or improved
BFE. This
does not
increase risk
associated
with the use of |
6
| Differential
Pressure
EN 14683:2019
Annex C | Pass @
5.1mm
H₂0/cm² | Pass @
5.1mm
H₂0/cm² | Pass @
2.0mm
H₂0/cm² | Pass @
1.0mm
H₂0/cm² | Pass @
2.5 mm
H₂0/cm² | the device
Different
The subject
device has
higher
differential
pressure, and
continues to
meet the
standard for
ASTM
classification
for 2 and 3.
This does not
increase risk
associated
with the use of
the device |
|------------------------------------------------------|----------------------------|----------------------------|----------------------------|----------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flammability
16 CFR Part
1610 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | | | | | | |
| Test | Subject Device | Predicate Device | | | Comparison | |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | | | Same | |
| Irritation | Non-irritating | Non-irritating | | | Same | |
| Sensitization | Non-sensitizing | Non-sensitizing | | | Same | |
Non-Clinical Performance Testing
The surgical mask has been tested according to ASTM 2100-19 -- Standard Specification for Performance of materials used in Medical Face Masks, and meets the requirements to be designated as ASTM Level 2 or Level 3, and have met the requirements for biocompatibility.
| Standard | Performance Characteristics, Level 2, 3 | Surgical Mask |
|---|---|---|
| ASTM F1862-17 | Resistance to Penetration by Synthetic | |
| Blood | Passed | |
| ASTM F2299 | Particulate Filtration Efficiency (PFE) | Passed |
| ASTM F2101-19 | Bacterial Filtration Efficiency (BFE) | Passed |
| EN 14683:2019 | ||
| Annex C | Differential Pressure | Passed |
| 16 CFR Part 1610 | Flammability of Clothing Textiles | Passed |
| ISO10993-1 | Biological Evaluation of Medical Devices - | |
| Part 1: Evaluation and Testing Within A | ||
| Risk Management Process | Met the requirements | |
| ISO10993-5 | Biological Evaluation of Medical Devices - | |
| Part 5: Tests for In Vitro Cytotoxicity | No cyctotoxicity or | |
| cell lysis was noted. | ||
| ISO10993-10 | Biological Evaluation of Medical Devices | |
| Part 10: Tests for Irritation and | ||
| Sensitization, 1ed | No evidence of | |
| sensitization or | ||
| irritation was | ||
| observed |
7
Clinical Performance
No Clinical study is included in this submission. The device as designed does not posed any new or additional risks to user or patient.
Summary of Test Results:
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed device identified as the predicate device, K160269.