(64 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 technology.
No
Explanation: A surgical face mask protects against the transfer of microorganisms and particulate material, which is a preventive measure, not a therapeutic action to treat or cure a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended to be worn for protection during surgical procedures, not for diagnosing any medical condition.
No
The device description clearly outlines a physical product made of non-woven materials, including a meltblown polypropylene filter and aluminum wire. The performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices, not software.
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 both the patient and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, nosepiece, loops). There is no mention of any components or mechanisms designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on physical properties like fluid resistance, filtration efficiency, differential pressure, flammability, and biocompatibility. These are relevant to the mask's function as a barrier, not as a diagnostic tool.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Product codes
FXX
Device Description
Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.
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 Officers, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Determination of Substantial Eauivalence:
- I. Fluid Resistance (ASTM F1862-05): Synthetic Blood Penetration Resistance Test
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM II. F2101-01) and Particulate Filtration Efficiency (Latex Particle Challenge) (ASTM F1215)
- III. Differential Pressure (Delta-P) Test (MIL M 36954 C)
- Flammability Test (16CFR 1610) IV.
- V. Biocompatibility per ISO 10993
Performance Results:
- Fluid Resistance: No Visual Penetration
- Particulate Filtration Efficiency Performance(%): Average 96.8% at 0.1 micron
- BFE (%): Higher than 99.9%
- Delta-P: Average 2.34
- Flammability Class: Class I (No Flame Spread)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance
- Particulate Filtration Efficiency Performance(%)
- BFE (%)
- Delta-P
- Flammability Class
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
MAY 2 5 2006
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K060776
1. Submitter's Identification:
Mr. Li Hua Zhu/General Manager Hong Ya Non-Woven Products Co., Ltd. Donggao Industry Zone Zanhuang, Hebei, P.R. China
Official Correspondent Kathy Liu Gloveco Inc. 3973 Schaefer Ave. Chino, CA 91710 Tel: 909-591-7888 Fax: 909-591-8896 Email: kathyliu@glovecoinc.com
Date Summary Prepared: March 1, 2006
2. Classification Name:
Classified by FDA's General and Plastic surgery Device panel as Class II, 21 CFR 878.4040, Surgical Apparel, 80FXX Mask, Surgical,
3. Regulatory Reference:
21 CFR 878.4040
4. Name of the Device:
Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink)
5. Predicate Device Information:
Tucker & Associates
Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green (K022256)
1
6. Device Description:
Device Deseributon.
Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.
7. Labels/Labeling:
This device will be marked to medical device suppliers, Dentist and Doctor Officers, Clinics, Emergency Response Professionals, Hospitals and other healthcare professionals for the Intended Use purpose below:
8. Intended Use:
Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
9. Comparison to Predicate Devices:
Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is substantially equivalent in safety and effectiveness to the Tuck & Associates Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green.
| Test | K022256 | Hong Ya Surgical Face
Mask (Yellow, White,
Green, Pink) |
|-----------------------------------------------------|-----------------------|---------------------------------------------------------------|
| Fluid Resistance | No Visual Penetration | Fluid Resistance |
| Particulate Filtration
Efficiency Performance(%) | 2.0 microns | Average 96.8% at 0.1
micron |
| BFE (%) | 97.9% | Higher than 99.9% |
| Delta-P | 1.8 | Average 2.34 |
| Flammability Class | 2 | Class I (No Flame Spread) |
2
10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Eauivalence are as follows:
- I. Fluid Resistance (ASTM F1862-05): Synthetic Blood Penetration Resistance Test
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM II. F2101-01) and Particulate Filtration Efficiency (Latex Particle Challenge) (ASTM F1215)
- III. Differential Pressure (Delta-P) Test (MIL M 36954 C)
- Flammability Test (16CFR 1610) IV.
- V. Biocompatibility per ISO 10993
It was our conclusion that performance testing met all relevant requirements of the aforementioned test standard.
11. Discussion of Clinical Tests Performed:
Not Applicable
12. Conclusions:
Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) has the same intended use and technological characteristics as the predicated devices (K022256). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is substantially equivalent to the predicated device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hong Ya Non-Woven Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated MAY 2 5 2006 3973 Schaefer Avenue Chino, California 91710
Re: K060776
Trade/Device Name: Surgical Face mask (Yellow, White, Green, Pink) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 16, 2006 Received: May 19, 2006
Dear Ms. Liu:
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.
4
Page 2 - Ms. Liu
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Carlson, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment A
INDICATIONS FOR USE
510(K) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME:
Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask-(Yellow, White, Green, Pink)
INDICATIONS FOR USE:
Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| concurrent of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------- | -- |
Jin. ... L
Shila K. Murphy, MD 5/24/06
esiblogy, General Hospits),