(654 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.
A therapeutic device is used to treat or cure a disease or condition, whereas this surgical face mask is intended for protection and prevention of microorganism transfer.
No
The device, a surgical face mask, is described as protecting from the transfer of microorganisms and particulate matter. Its performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, not on diagnosing medical conditions.
No
The device description explicitly states it is a "Non-sterile surgical face mask," which is a physical hardware device. The performance studies also focus on physical characteristics like fluid resistance, filtration efficiency, and flammability.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect from the transfer of microorganisms, body fluids, and particulate material by being worn. This is a barrier function, not a diagnostic function.
- Device Description: It's a surgical face mask.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on barrier properties (fluid resistance, filtration efficiency, flammability), which are relevant to a protective device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Product codes
FXX
Device Description
Non-sterile surgical face mask, white, yellow, pink, blue and green.
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
medical device suppliers, Dentist and Doctor Offices, Clinics, Emergency Response Professionals, Hospitals and other healthcare professionals
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 device was tested against (ASTM F2299-03, ASTM F1862-00a, ASTM F2101-01, MIL M 36945C4.4.1.1.1, 15 CFR 1610.4) and passed all recommended standards and/or tests.
Performance Characteristics Test Method Acceptance Criteria/Results
Fluid Resistance Performance: ASTM F-1862-00a, No visual detection of penetration
Filter Efficiency Performance: 2.0 Microns, Passed 2.0 Micron Test
Bacterial Filtration Efficiency Performance (%)(BFE): ASTM F-2101-01, Passed at 97.9%
Differential Pressure (Delta-P): MIL M 36945C4.4.1.1.1, Passed at 1.8
Flammability Class: 16 CFR 1610, Passed at Flammability Class 2
Key Metrics
Not Found
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
APR 2 6 2004
510(k) SUMMARY K022256
| Submitted For: | TUCKER & ASSOCIATES
198 Ave. de la D'emerald
Sparks, Nevada 89434-9550 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | JANNA P. TUCKER, President - CEO
And Official Correspondent for
Tucker & Associates
198 Avenue de la D'emerald
Sparks, NV 89434
Phone: 775-342-2612
Fax: 775-342-2613
E-mail: Tuckerjan@aol.com |
| Date of Submission: | Original: 12 July 2002, "Add to File" revisions and
additions 2 April 2004 |
| Classification Name: | Surgical Face Mask, FXX, Class 2 Device |
| Proprietary Name:
Common Name:
Regulatory Reference:
Predicate Device: | (Multiple Labels)
Face Mask, Surgical
21 CFR 878.
Face Mask, Surgical Mask, K970835 |
| Labels/Labeling: | This device will be marketed to medical device suppliers,
Dentist and Doctor Offices, Clinics, Emergency Response
Professionals, Hospitals and other healthcare professionals
for the Intended Use purposes below. |
| Intended Use: | This device is intended to be worn to protect both the
patient and healthcare personnel from transfer of
microorganisms, body fluids and particulate material. |
| Description: | Non-sterile surgical face mask, white, yellow, pink, blue
and green. |
| Substantial Equivalence: | This device is equivalent to one in commercial distribution
approved K970835, but specifically, and most importantly,
it has passed all recommended standards and/or tests as
follows: |
| | |
| | Standards and/or tests: |
| ASTM F2299-03 | ...materials used in Face Masks |
| ASTM F1862-00a | ...Resistance of Medical Face Masks to Penetration |
| | By Synthetic Blood |
| | ASTM F2101-01 |
| | Medical Face Mask Materials. |
| | MIL M 36945C4.4.1.1.1 |
| 15 CFR 1610.4 | Flammability Class - tested at flammability Class 2 |
| | Biocompatibility and Agar Diffusion Tests successfully completed. |
EXHIBIT J
Page 73 of 88
Revised 04-02-04
gk
1
Page 2, 510(k) Summary K022256
Performance Characteristics Test Method Acceptance Criteria/Results
| Fluid Resistance Performance | ASTM F-1862-00a | No visual detection of penetration |
|---|---|---|
| Filter Efficiency Performance | 2.0 Microns | Passed 2.0 Micron Test |
| Bacterial Filtration Efficiency | ||
| Performance (%) (BFE) | ASTM F-2101-01 | Passed at 97.9% |
| Differential Pressure (Delta-P) | MIL M 36945C4.4.1.1.1 | Passed at 1.8 |
| Flammability Class | 16 CFR 1610 | Passed at Flammability Class 2 |
EQUIVALENCY COMPARISONS:
| Current Device | ||
|---|---|---|
| K970835 | K022256 | |
| Fluid Resistance | Fluid Resistant | No visual penetration |
| Filter Efficiency Performance (microns) | 2.9 microns | 2.0 microns |
| BFE % | 96.4% | 97.9% |
| Delta-P | 1.7 | 1.8 |
| Flammability Class | 3 | 2 |
Conclusion:
This device is substantially equivalent to the device approved as K970835
EXHIBIT J
Page 74 of 88
Revised 04-02-04
gt.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a symbol that looks like three stylized waves or lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Tucker & Associates Ms. Janna Tucker Official Correspondents 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K022256
Trade/Device Name: Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: April 2, 2004 Received: April 6, 2004
Dear Ms. Tucker:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Tucker
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
TUCKER AND ASSOCIATES APPLICANT: -KO22256 510(k) NUMBER:
DEVICE NAME: SURGICAL FACE MASK Colors: White, Yellow, Pink, Blue And Green
This device is intended to be worn to protect both the patient and healthcare personnel From transfer of microorganisms, body fluids and particulate material
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin Mulvey
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K022254
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