(90 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, cure, or prevent a disease or condition. This device is a filter and barrier, used to prevent the transfer of microorganisms, not to treat any condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is intended "to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material." This function is protective, not diagnostic.
No
The device description clearly outlines physical components (pleated 3-ply masks, spunbonded polypropylene, meltblown polypropylene filter material, elastic loops/strip, malleable aluminum wire) and the performance studies are based on physical testing of these materials and the mask's physical properties. There is no mention of software as a component or function of the device.
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). There is no mention of any components or functions related to analyzing samples or providing 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 barrier function, not diagnostic accuracy.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing any kind of diagnostic result.
In vitro diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This surgical face mask does not perform any such function.
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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) 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
operating room personnel
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 Equivalence:
- Fluid Resistance (ASTM F1862-00a): Synthetic Blood Penetration Resistance Test
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM F2101-01) and Particulate Filtration Efficiency (Latex Particle Challenge) (ASTM F1215-89)
- Differential Pressure (Delta P) Test (MIL M 36954C)
- Flammability Test (16 CFR 1610)
- Biocompatibility per ISO 10933
Performance testing met all relevant requirements of the aforementioned test standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance: Fluid Resistant
Particulate Filtration Efficiency Performance: Average 98.8% at 0.1 micron
BFE: 99.4%
Delta-P: 1.6
Flammability Class: 1
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: KO43/99
K043/99
1.__Submitter's Identification:
Mr. Li Hua Zhu/General Manager Hong Ya Non-Woven Products Co., Ltd. Donggao Industry Zone Zanhuang, Hebei Province P.R. China
Official Correspondent and US Agent: James Chu Gloveco Inc. 590 W. Central Avenue, #D Brea, CA 92821 Tel: 714-990-6888 Fax: 714-990-6478 Email: jameschu@glovecoinc.com
Date Summary Prepared: September 09, 2004
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 (Blue)
5. Predicate Device Information:
Tucker & Associates
Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green (K022256)
1
6. Device Description:
Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.
7. Labels/Labeling:
This device will be marked to medical device suppliers, Dentist and Doctor Offices, 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 Products Co., Ltd. Surgical Face Mask (Blue) is substantially equivalent in safety and effectiveness to the Tucker & Associates Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green.
| Test | K022256 | Hong Ya Surgical Face
Mask (Blue) |
|---------------------------------------------------------|-----------------------|--------------------------------------|
| Fluid Resistance | No visual Penetration | Fluid Resistant |
| Particulate Filtration
Efficiency Performance
(%) | 2.0 microns | Average 98.8% at 0.1 micron |
| BFE (%) | 97.9% | 99.4% |
| Delta-P | 1.8 | 1.6 |
| Flammability Class | 2 | 1 |
2
10. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
- Fluid Resistance (ASTM F1862-00a): Synthetic Blood Penetration Resistance l . 'l`est
- Filtration Efficiency: Bacterial Filtration Efficiency (BFE) Test (ASTM II. F2101-01) and Particulate Filtration Efficiency (Latex Particle Challenge) (ASTM F121589)
- Differential Pressure (Delta P) Test (MIL M 36954C) III.
- IV. Flammability Test (16 CFR 1610)
- Biocompatibility per ISO 10933 V.
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 (Blue) 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 questions of safety or effectiveness. Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue) is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of one.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hong Ya Non-Woven Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 W. Central Avenue, #D Brea, California 92821
Re: K043199
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: February 1, 2005 Received: February 2, 2005
Dear Mr. Chu:
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 vour 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 – Mr. Chu
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 moun that I Dr mas made 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 and ifoung (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form aroduct radiation control provisions (Sections 531-542 of the Act); appress 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 m 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), 11 you donto 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,
Syrtle Machie, M.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:
043199 Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue)
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)
. Try try for for rel
(Drision Sign-Off)
Division of Anesthesiology, General Hospital,
...
Ohy
2/16/05
Infection Control Dental Devices 510(k) Number