(373 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device, a surgical face mask, is intended to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. It does not actively treat or prevent a disease, nor does it affect the structure or function of the body, which are characteristics of a therapeutic device.
No
The device is a surgical face mask, whose intended use is to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (layers of polypropylene, ear loops, nose wire) and the performance studies focus on material properties and physical filtration, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask, which is consistent with a barrier device.
- Performance Studies: The performance studies focus on barrier properties (filtration efficiency, breathability, flammability, biocompatibility), not on analyzing samples from the human body to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device's purpose is to physically prevent the transfer of substances, not to provide information about a person's health status through the analysis of samples.
N/A
Intended Use / Indications for Use
The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.
Product codes
FXX
Device Description
The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user's 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
operating room personnel, patients, and other general healthcare workers
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
The proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993 in order to determine substantial equivalence. The following tests were conducted on the proposed Surgical Face Masks:
- ASTM F1862 Test Method for Resistance of Medical Face Masks to Penetration l. by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- II. ASTM F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- III. ASTM F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- IV. EN 14683:2019, Annex C Method for Determination of Breathability (Differential Pressure)
- V. 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- VI. ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- VII. ISO 10993-10 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
All results of testing met ASTM F2100-19 level 3 acceptance criteria.
Key Metrics
- Fluid Resistance ASTM 1862 (160 mmHg): Pass
- Particulate Filtration Efficiency ASTM F2299 (0.1 micron): Avg. 99.0%
- Bacterial Filtration Efficiency ASTM F2101: Avg. 99.1%
- Differential Pressure ASTM F2100-19: Avg. 4.9 mmH2O/cm^2
- Flammability 16 CFR Part 1610: Class 1
- Biocompatibility ISO 10993-5 & ISO 10993-10 (Cytotoxicity, Irritation, Sensitization): Pass
Predicate Device(s)
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). 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.
July 14, 2021
Lear Corporation Ryan Facer Product Development Engineer 1 Penn Dve St Pine Grove, Pennsylvania 17963
Re: K201844
Trade/Device Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 15, 2021 Received: June 16, 2021
Dear Ryan Facer:
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
1
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 mediation-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) K201844
Device Name
Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask
Indications for Use (Describe)
The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healtheare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.
| 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
5. 510(k) Summary Report
K201844
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
Date Prepared: 06/10/2021
5.1. Submitter's Identification
Guilford Performance Textiles by Lear 1 Penn Dye St Pine Grove, PA 17963 USA
Contact Person: Ryan Facer Telephone: (336) 341-8687 Email: rfacer@lear.com
5.2. Device & Regulatory Information
Trade Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Model Number: 69005 Common Name: Surgical Mask 510(k) Number: K201844 Classification Name: Mask, Surgical Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040
5.3. Predicate Device
Submitter: DemeTECH Corporation 510(k) Number: K201479 Device Name: DemeMASK Surgical Mask
5.4. Device Description:
The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user's nose.
4
The types of materials used in the proposed Surgical Face Mask are currently being used in legally marketed devices.
5.5. Contact
Type: Surface Device – Intact Skin Contact Duration: Limited – Less than 24 hours
5.6. Intended Use
The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single-use, disposable device.
5.7. Comparison to Predicate Device
5.7.1. Intended Use/Indications for Use
| Proposed Surgical Face Mask
(K201844) | Predicate Surgical Mask
(K201479) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| The Surgical Face Mask is intended
for single use by operating room
personnel, patients, and other
general healthcare workers to
protect against the transfer of
microorganisms, blood, bodily fluids,
and particulates. This is a non-
sterile, single use, disposable device. | The Disposable 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 the potential exposure to
blood and body fluids. This is a
single use, disposable device
provided non-sterile. | Intended use/
Indications for Use is
the same as the
predicate device |
5.7.2. Materials, Technical Specifications, & Risks to Health
| Description | Proposed Surgical
Face Mask
(K201844) | Predicate Surgical
Mask
(K201479) | Comparison | |
|-------------|---------------------------------------------|-------------------------------------------------------|------------------------------------------------|------------------------------------|
| Materials | Inner Layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same as the
predicate device |
| | Middle Layer | Melt blown
polypropylene | Melt blown
polypropylene | Same as the
predicate device |
| | Outer Layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same as the
predicate device |
| | Nose Wire | Galvanized steel wire
coated with
polypropylene | Galvanized wire
coated with
polyethylene | Similar to the
predicate device |
5
| | Elastic ear-loops | Nylon & spandex | Nylon & spandex | Same as the
predicate device |
|--------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|------------------------------------|
| | Mask Style | Flat Pleated | Flat pleated | Same as the
predicate device |
| Specifications | Design Feature | Ear loops
(Length: 150 mm) | Ear loops
(Length: not provided) | Similar to
predicate device |
| | Nose Wire | Length: 110 mm | Info not provided | Similar to
predicate device |
| | Mask Dimensions | Length - 6.89 in
Width – 3.74 in | Length - 6.89 in
Width — 3.74 in | Same as the
predicate device |
| Performance
test
results | Fluid Resistance
ASTM 1862
(160 mmHg) | Pass | Pass | Same as the
predicate device |
| | Particulate
Filtration
Efficiency
ASTM F2299
(0.1 micron) | Avg. 99.0% | ≥99% | Similar to the
predicate device |
| | Bacterial Filtration
Efficiency
ASTM F2101 | Avg. 99.1% | ≥99% | Similar to the
predicate device |
| | Differential
Pressure
ASTM F2100-19 | Avg. $4.9 mmH_2O/cm^2$ | * Avg. $3.6 mmH_2O/cm^2$ | Similar to
predicate device |
| | Flammability
16 CFR Part 1610 | Class 1 | Class 1 | Same as the
predicate device |
| | Biocompatibility
ISO 10993-5 & ISO
10993-10
(Cytotoxicity,
Irritation,
Sensitization) | Pass | Pass | Same as the
predicate device |
*Predicate device was tested per MIL-M36954C.
5.8. Summary of Nonclinical Testing
The proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993 in order to determine substantial equivalence. The following tests were conducted on the proposed Surgical Face Masks:
- ASTM F1862 Test Method for Resistance of Medical Face Masks to Penetration l. by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
6
- II. ASTM F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- III. ASTM F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- IV. EN 14683:2019, Annex C Method for Determination of Breathability (Differential Pressure)
- V. 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- VI. ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- VII. ISO 10993-10 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
All results of testing met ASTM F2100-19 level 3 acceptance criteria.
5.9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201844, the Surgical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201479.