(127 days)
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.
No
The device is a surgical face mask intended to protect from transfer of microorganisms and particles, not to provide therapy.
No
Explanation: The device is a surgical face mask intended to protect from transfer of microorganisms, body fluids, and airborne particles, not to diagnose a condition.
No
The device description clearly states it is a physical surgical face mask made of polypropylene layers, ear loops, and a nose piece. The performance studies also focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting patients and healthcare workers from the transfer of microorganisms, body fluids, and airborne particles. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of a surgical face mask, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the barrier properties of the mask (filtration efficiency, fluid resistance, breathability), not on diagnostic accuracy.
- Predicate Device: The predicate device is listed as "Mask, Surgical Apparel," which is consistent with a non-IVD device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any of these functions.
N/A
Input:
**0**
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2020
Base4 Group, Inc. % Thomas Knott Senior Regulatory Advisor Benjamin L. England and Associates, LLC 810 Landmark Dr, Suite 126 Glen Burnie, Maryland 21061
Re: [K202069](https://510k.innolitics.com/search/K202069)
Trade/Device Name: BASE4 Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 2, 2020 Received: November 2, 2020
Dear Thomas Knott:
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
**1**
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,
For CAPT Elizabeth Claverie, M.S. 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) [K202069](https://510k.innolitics.com/search/K202069)
Device Name Surgical Face Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
| 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)
#### 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."
**3**
# 510(k) SUMMARY
# Date of Summary Prepared: November 25, 2020 510(k) Number: [K202069](https://510k.innolitics.com/search/K202069)
| Submitted By: | Benjamin L. England And Associates, LLC |
|---------------|----------------------------------------------------------|
| Address: | 810 Landmark Drive
Suite 126
Glen Burnie, MD 21061 |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@englandlawgroup.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
| On Behalf of: | BASE4 Group, Inc. |
| Address | 4393 Sunbelt Drive
Addison, TX 75001 |
| Phone: | (972) 331-6619 |
| Fax: | |
| E-Mail: | Jon@ebase4.com |
| Contact: | Jon Filipski |
### 1. Regulatory Information
| Proprietary Name: | BASE4 Disposable Medical Mask (NB Green2020-12; Model
Number is 07787) |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Surgical Face Mask, Apparel |
| Common Name: | Surgical face mask |
| Classification: | Class II |
| Product Code: | FXX |
| Panel | General Surgery Devices |
| Regulation: | 21 CFR 878.4040 |
### 2. Predicate Device
| 510(k) Number: | [K200847](https://510k.innolitics.com/search/K200847) |
|----------------|------------------------|
| Device Name: | Mask, Surgical Apparel |
## 3. Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
**4**
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
## 5. Summary of Comparison and Technological Characteristics
#### Table 1 - General Comparison
4. Device Description
| CLASSIFICATION INFORMATION | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 510(k) Number | [K202069](https://510k.innolitics.com/search/K202069) | [K200847](https://510k.innolitics.com/search/K200847) | N/A |
| Manufacturer | Ningbo Green Textile Co., Ltd | Mexpo International, Inc. | N/A |
| Common Name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II | Class II | Same |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use | When properly worn, the
surgical face masks are
intended to protect both patient
and healthcare workers from
transfer of microorganisms,
body fluids and airborne
particles. This device is non-
sterile and for single use only | When properly worn, the surgical
face masks are intended to
protect both patient and
healthcare workers from transfer
of microorganisms, body fluids
and airborne particles. This
device is non-sterile and for
single use only | Same |
| Model | Three ply, flat pleated, ear
loops | 3 Ply, Ear Loops, Flat-Pleated
Style | Same |
| Tensile Strength | 10 - 15 N | N/A | N/A |
| MATERIALS | | | |
|--------------|------------------------------------|----------------------------------------|---------|
| | | | |
| Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene
Filter | Melt Blown Polypropylene
Filter | Same |
| Inner Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Galvanized wire coated by PVC | Single Galvanize Wire, Coated
By PE | Similar |
| Ear Loops | 70% polyester; 30% spandex | not made with natural rubber
latex | Unknown |
| Color | Blue outer layer | White | Differs |
| Width | 95 mm = 9.5 cm | 9.0cm ± 0.5cm | Same |
| Length | 175 mm = 17.5 cm | 17.5cm ± 0.5cm | Same |
| OTC Use? | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use? | Yes | Yes | Same |
| ASTM F2100 | Level 2 | Level 2 | Same |
**5**
| ASTM F1862
Fluid
Resistance
Performance | 31 out of 32 pass at 80 mm Hg
30 out of 32 pass at 120 mm Hg | 30 Out of 32 pass at 120 mm Hg | Same |
|---------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------|----------------------|
| ASTM F2299
Particulate
Filtration
Efficiency | 98.8% | 99.9% | Both Pass
Similar |
| ASTM F2101
Bacterial
Filtration
Efficiency | > 99.9% | > 99.9% | Same |
| Differential
Pressure (Delta
P) MIL- M-
36954C | 4.4 mmH20/cm² | 3.0 mmH20/cm² | Both Pass
Similar |
| Flammability
16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility
Testing | Non-Cytotoxic, Non-
Sensitizing, Non-Irritating | Non-Cytotoxic, Non-
Sensitizing, Non-Irritating | Same |
The outer layer of the subject mask is colored blue, and the predicate device is white. Otherwise, they are the same material, polypropylene. The outer layer does not contact the patient's skin and therefore presents minimal risk to the health of the user.
The nose piece for both devices is galvanized wire. The subject device is covered by PVC and the predicate device is covered by PE. However, neither material will contact the user's skin so there is no difference in risk to the health of the user.
The 510(k) Summary for the predicate device does not show the material for the ear loops. Therefore, no comparison can be made.
The Particulate Filtration Efficiency and Differential Pressures are similar for both masks and pass the specification required by ASTM F2100 for a level 2 mask.
### 6. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
- . ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- . 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)
- . ASTM F2299/F2299M-03: Determining the Initial Efficiency of Materials Used in Medical Face Masks to the Penetration of Particulates Using Latex Spheres
- . ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- . MIL - M-36954C: Medical face masks - Requirements and test methods, Annex C
**6**
- 16 CFR 1610 CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for ● Flammability of Clothing Textiles.
- ISO 10993-5: Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-10: Biological evaluation of medical devices Part 10:Tests for irritation and skin sensitization
#### Table 2 - Performance Testing
| Test | Proposed Device | Acceptance Criteria | Result |
|---------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------|-----------------|
| Fluid
Resistance
Performance
ASTM F1862 | 31 out of 32 pass at 80 mm Hg
30 out of 32 pass at 120 mm Hg | 29 out of 32 pass at 120 mm
Hg | Pass
Level 2 |
| Particulate
Filtration
Efficiency
ASTM F2299 | 98.8% | ≥ 98% | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | > 99.9% | ≥ 98% | Pass |
| Differential
Pressure (Delta
P) MIL- M-
36954C | 4.4 mmH20/cm² |
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2020
Base4 Group, Inc. % Thomas Knott Senior Regulatory Advisor Benjamin L. England and Associates, LLC 810 Landmark Dr, Suite 126 Glen Burnie, Maryland 21061
Re: K202069
Trade/Device Name: BASE4 Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 2, 2020 Received: November 2, 2020
Dear Thomas Knott:
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
1
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,
For CAPT Elizabeth Claverie, M.S. 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) K202069
Device Name Surgical Face Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
| 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)
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."
3
510(k) SUMMARY
Date of Summary Prepared: November 25, 2020 510(k) Number: K202069
| Submitted By: | Benjamin L. England And Associates, LLC |
|---|---|
| Address: | 810 Landmark Drive |
| Suite 126 | |
| Glen Burnie, MD 21061 | |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@englandlawgroup.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
| On Behalf of: | BASE4 Group, Inc. |
| Address | 4393 Sunbelt Drive |
| Addison, TX 75001 | |
| Phone: | (972) 331-6619 |
| Fax: | |
| E-Mail: | Jon@ebase4.com |
| Contact: | Jon Filipski |
1. Regulatory Information
| Proprietary Name: | BASE4 Disposable Medical Mask (NB Green2020-12; Model
Number is 07787) |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Surgical Face Mask, Apparel |
| Common Name: | Surgical face mask |
| Classification: | Class II |
| Product Code: | FXX |
| Panel | General Surgery Devices |
| Regulation: | 21 CFR 878.4040 |
2. Predicate Device
| 510(k) Number: | K200847 |
|---|---|
| Device Name: | Mask, Surgical Apparel |
3. Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
4
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
5. Summary of Comparison and Technological Characteristics
Table 1 - General Comparison
- Device Description
| CLASSIFICATION INFORMATION | |||
|---|---|---|---|
| 510(k) Number | K202069 | K200847 | N/A |
| Manufacturer | Ningbo Green Textile Co., Ltd | Mexpo International, Inc. | N/A |
| Common Name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II | Class II | Same |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Intended use | When properly worn, the | ||
| surgical face masks are | |||
| intended to protect both patient | |||
| and healthcare workers from | |||
| transfer of microorganisms, | |||
| body fluids and airborne | |||
| particles. This device is non- | |||
| sterile and for single use only | When properly worn, the surgical | ||
| face masks are intended to | |||
| protect both patient and | |||
| healthcare workers from transfer | |||
| of microorganisms, body fluids | |||
| and airborne particles. This | |||
| device is non-sterile and for | |||
| single use only | Same | ||
| Model | Three ply, flat pleated, ear | ||
| loops | 3 Ply, Ear Loops, Flat-Pleated | ||
| Style | Same | ||
| Tensile Strength | 10 - 15 N | N/A | N/A |
| MATERIALS | |||
|---|---|---|---|
| Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene | ||
| Filter | Melt Blown Polypropylene | ||
| Filter | Same | ||
| Inner Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Galvanized wire coated by PVC | Single Galvanize Wire, Coated | |
| By PE | Similar | ||
| Ear Loops | 70% polyester; 30% spandex | not made with natural rubber | |
| latex | Unknown | ||
| Color | Blue outer layer | White | Differs |
| Width | 95 mm = 9.5 cm | 9.0cm ± 0.5cm | Same |
| Length | 175 mm = 17.5 cm | 17.5cm ± 0.5cm | Same |
| OTC Use? | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use? | Yes | Yes | Same |
| ASTM F2100 | Level 2 | Level 2 | Same |
5
| ASTM F1862
Fluid
Resistance
Performance | 31 out of 32 pass at 80 mm Hg
30 out of 32 pass at 120 mm Hg | 30 Out of 32 pass at 120 mm Hg | Same |
|---------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------|----------------------|
| ASTM F2299
Particulate
Filtration
Efficiency | 98.8% | 99.9% | Both Pass
Similar |
| ASTM F2101
Bacterial
Filtration
Efficiency | > 99.9% | > 99.9% | Same |
| Differential
Pressure (Delta
P) MIL- M-
36954C | 4.4 mmH20/cm² | 3.0 mmH20/cm² | Both Pass
Similar |
| Flammability
16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility
Testing | Non-Cytotoxic, Non-
Sensitizing, Non-Irritating | Non-Cytotoxic, Non-
Sensitizing, Non-Irritating | Same |
The outer layer of the subject mask is colored blue, and the predicate device is white. Otherwise, they are the same material, polypropylene. The outer layer does not contact the patient's skin and therefore presents minimal risk to the health of the user.
The nose piece for both devices is galvanized wire. The subject device is covered by PVC and the predicate device is covered by PE. However, neither material will contact the user's skin so there is no difference in risk to the health of the user.
The 510(k) Summary for the predicate device does not show the material for the ear loops. Therefore, no comparison can be made.
The Particulate Filtration Efficiency and Differential Pressures are similar for both masks and pass the specification required by ASTM F2100 for a level 2 mask.
6. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
- . ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- . 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)
- . ASTM F2299/F2299M-03: Determining the Initial Efficiency of Materials Used in Medical Face Masks to the Penetration of Particulates Using Latex Spheres
- . ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- . MIL - M-36954C: Medical face masks - Requirements and test methods, Annex C
6
- 16 CFR 1610 CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for ● Flammability of Clothing Textiles.
- ISO 10993-5: Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-10: Biological evaluation of medical devices Part 10:Tests for irritation and skin sensitization
Table 2 - Performance Testing
| Test | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid | |||
| Resistance | |||
| Performance | |||
| ASTM F1862 | 31 out of 32 pass at 80 mm Hg | ||
| 30 out of 32 pass at 120 mm Hg | 29 out of 32 pass at 120 mm | ||
| Hg | Pass | ||
| Level 2 | |||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2299 | 98.8% | ≥ 98% | Pass |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | > 99.9% | ≥ 98% | Pass |
| Differential | |||
| Pressure (Delta | |||
| P) MIL- M- | |||
| 36954C | 4.4 mmH20/cm² |