(302 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the surgical mask is for protection against transfer of microorganisms and fluids, not for treating any medical condition.
No
The device description clearly states it is a "Surgical Mask (Procedure Mask)" intended to protect from microorganisms and body fluids, and the performance studies refer to physical properties like fluid resistance and filtration efficiency, not diagnostic capabilities.
No
The device description clearly outlines a physical, multi-layer mask construction with a nose clip and ear loops or ties. The performance studies focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical mask is "intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." This describes a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask and its materials. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency, and flammability. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
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 mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) 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(s), provided non-sterile.
Product codes
FXX
Device Description
The proposed Surgical Mask (Procedure Mask) body is a multi-layer construction of a Spun- bond polypropylene outer layer, meltblown middle layer and Spun-bond polypropylene inner layer. Nose clip is made of Aluminum plastic wire. There are two models of the proposed Surgical Mask (Procedure Mask), OH02-01 and OH02-01(Bandage). The main difference between each model is their wearing method, i.e. mask band part. For OH02-01 model, mask band part is made of non-woven fabric ear loops. For OH02-01(Bandage) model, mask band part is made of non-woven fabric ties. However, the raw materials of the two models devices are exactly the same. And have been tested according to ASTM F2100-19 Standard Specification For Performance Of Materials Used In Medical Face Masks. Surgical Mask (Procedure Mask) is a single use, disposable medical device that will be provided in non-sterile packaging configurations.
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
healthcare 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 were performed. These include:
- Fluid Resistance Performance (ASTM F1862): 32 out of 32 Pass at 160 mmHg (Average of 3 lots with 32 samples per lot). Result: Pass.
- Particulate Filtration Efficiency (ASTM F2299): Pass at 99.12% (Average of 3 lots with 32 samples per lot). Result: Pass.
- Bacterial Filtration Efficiency (ASTM F2101): Pass at 99.79% (Average of 3 lots with 32 samples per lot). Result: Pass.
- Differential Pressure (Delta P) MILM-36954C: 3.57 mmH2O/cm² (Average of 3 lots with 32 samples per lot). Result: Pass.
- Flammability 16 CFR 1610: Class 1 (Average of 3 lots with 32 samples per lot) (16 CFR 1610). Result: Pass.
Biocompatibility tests performed:
- Cytotoxicity (ISO 10993-5:2009): Non-Cytotoxic.
- Irritation (ISO 10993-10: 2010): Non-Sensitizing.
- Sensitization (ISO 10993-10: 2010): Non-Irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 17, 2021
Ningbo Ouhan Medical Device Co., Ltd. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara, California 95054
Re: K203418
Trade/Device Name: Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 19, 2021 Received: August 25, 2021
Dear Rafi Wong:
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 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,
Liqun Zhao -S
For Clarence W. Murray, III, PhD. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203418
Device Name
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
Indications for Use (Describe)
Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) 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(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY of K203418
Date of Summary Prepared: September 16, 2021 510K Number: K203418
1. Submitter Information
Submitter Contact: Ningbo Ouhan Medical Device Co., Ltd. Address: No.16, West Ruhu Road, Simen Town, Yuyao City, Zhejiang, China, 315470 Fax number: +86 (574)-62137995
Submitter Contact Person: Name: Annie Phone Number: +86 (574)-62137999 Email: annie@ouhanmedical.com
Designated Submission Correspondent: Name: Rafi Wong Phone Number: +1 (408) 646-6537 Email: rafi.wong@pfmfinance.com
2. Device Name:
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
3. Regulatory Information
Classification Name: Mask, Surgical Common Name: Surgical Apparel Apparel Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040
4. Predicate Device
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510K Number: K200923 - BYD Precision Manufacturer Co.Ltd. Device Name: Single-use Surgical Mask Cleared date: August 26, 2020
5. Intended Use/Indications for use
Surgical Mask (Procedure Mask) (Models: OH02-01 (Bandage)) 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(s), provided non-sterile.
6. Device Description
The proposed Surgical Mask (Procedure Mask) body is a multi-layer construction of a Spun- bond polypropylene outer layer, meltblown middle layer and Spun-bond polypropylene inner layer. Nose clip is made of Aluminum plastic wire. There are two models of the proposed Surgical Mask (Procedure Mask), OH02-01 and OH02-01(Bandage). The main difference between each model is their wearing method, i.e. mask band part. For OH02-01 model, mask band part is made of non-woven fabric ear loops. For OH02-01(Bandage) model, mask band part is made of non-woven fabric ties. However, the raw materials of the two models devices are exactly the same. And have been tested according to ASTM F2100-19 Standard Specification For Performance Of Materials Used In Medical Face Masks. Surgical Mask (Procedure Mask) is a single use, disposable medical device that will be provided in non-sterile packaging configurations.
7. Summary of Comparison and Technological Characteristics
| Items | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Common Name | Surgical Mask | ||
| (Procedure Mask) | Single-use Surgical | ||
| Mask | Difference | ||
| Manufacturer | Ningbo Ouhan | ||
| Medical Device | |||
| Co., | |||
| Ltd. | BYD Precision | ||
| Manufacturer | |||
| Co.Ltd. | - |
Table I - General Comparison
5
| 510K Number | K203418 | K200923 | - | |
|---|---|---|---|---|
| Product Code | FXX | FXX | Same | |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same | |
| Intended Use/Indications for Use | Surgical Mask | |||
| (Procedure Mask) | ||||
| (Models: OH02-01, | ||||
| OH02-01 (Bandage)) | ||||
| 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(s), | ||||
| provided non-sterile. | The Single- | |||
| use Surgical | ||||
| Masks | ||||
| (Model:FE2311) | ||||
| 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(s), | ||||
| provided non-sterile. | Same | |||
| Model | Flat | |||
| earhook | ||||
| type, 3 | ||||
| layers | Ear loop, Flat | |||
| Pleated, 3 layers | Similar | |||
| Materials | Outer Layer | Spun-bond | ||
| polypropylene | Spun-bond | |||
| polypropylene | Same | |||
| Middle Layer | Meltblown | |||
| polypropylene filter | Melt blown | |||
| polypropylene filter | Same | |||
| Inner Layer | Spun-bond | |||
| polypropylene | Spun-bond | |||
| polypropylene | Same | |||
| Nose Piece | Aluminum plastic | |||
| wire | Metal Core Plastic | Similar | ||
| Ear Loops/Ties | Non-woven fabric | Polyester | Difference | |
| Color | Blue And White | Blue | Similar | |
| Dimension (Width) | 17.5 cm +/- 0.5 cm | 17.5 cm +/- 0.4 cm | Similar | |
| Dimension (Length) | 9.5 cm +/- 0.5 cm | 9.5 cm +/- 0.4 cm | Similar | |
| OTC Use | Yes | Yes | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| Sterilization modality | - | - | Same | |
| ASTM F2100-19 Level | Level 3 | Level 3 | Same | |
| Performance | ||||
| Testing | Fluid | |||
| Resistance | ||||
| Performance | ||||
| ASTM F1862 | 32 out of 32 Pass at | |||
| 160 mmHg | 32 out of 32 Pass at | |||
| 160 mmHg | Same | |||
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM F2299 | Pass at 99.12% | Pass at 99.67% | Similar | |
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM F2101 | Pass at 99.79% | Pass at 99.95% | Similar | |
| Differential | ||||
| Pressure (Delta | ||||
| P) MILM- | ||||
| 36954C | 3.57 mmH2O/cm² | 5.62 mmH2O/cm² | Similar | |
| Flammability | ||||
| 16 CFR 1610 | Class 1 | |||
| (16 CFR 1610) | Class 1 | |||
| (16 CFR 1610) | Same | |||
| Biocompatibility | ||||
| Testing (ISO | ||||
| 10993-1) | Cytotoxicity | |||
| ISO 10993-5: | ||||
| 2009 | Non-Cytotoxic | Non-Cytotoxic | Same | |
| Irritation | ||||
| ISO 10993-10: | ||||
| 2010 | Non-Sensitizing | Non-Sensitizing | Same | |
| Sensitization | ||||
| ISO 10993-10: | ||||
| 2010 | Non-Irritating | Non-Irritating | Same |
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*The difference in the materials and colors does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
8. 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.
STANDARDS:
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- ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face ● Masks.
- ASTM F1862-13, Standard Test Method For Resistance Of Medical Face Masks To Penetration ● By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity).
- . ASTM F2299-03, Standard Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610, Standard For The Flammability Of Clothing Textiles. .
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity.
- 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And ● Skin Sensitization.
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | In order to verify | ||
| whether the subject | |||
| device meets the | |||
| performance | |||
| requirements of ASTM | |||
| F2100 level 3, | |||
| Resistance to penetration | |||
| by synthetic blood, | |||
| minimum pressure in | |||
| mm Hg for pass result: | |||
| Fluid resistant claimed at | |||
| 160 mm Hg | Fluid resistant claimed | ||
| at 160 mm Hg | 32 out of 32 Pass at | ||
| 160 mmHg (Average | |||
| of 3 lots with 32 | |||
| samples per lot) | |||
| Pass | |||
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | In order to verify | ||
| whether the subject | |||
| device meets the | |||
| performance | ≥ 98% | Pass at 99.12% | |
| (Average of 3 lots | |||
| with 32 samples per | |||
| lot) | |||
| requirements of ASTM | |||
| F2100 level 3, Sub- | |||
| micron particulate | |||
| filtration efficiency at 0.1 | |||
| um of Polystyrene Latex | |||
| Spheres: ≥ 98% | Pass | ||
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | In order to verify | ||
| whether the subject | |||
| device meets the | |||
| performance | |||
| requirements of ASTM | |||
| F2100 level 3, Bacterial | |||
| filtration efficiency: ≥ | |||
| 98% | ≥ 98% | Pass at 99.79% | |
| (Average of 3 lots | |||
| with 32 samples per | |||
| lot) | |||
| Pass | |||
| Differential Pressure | |||
| (Delta P) MILM- | |||
| 36954C | In order to verify | ||
| whether the subject | |||
| equipment meets the | |||
| performance | |||
| requirements of ASTM | |||
| F2100 level 3, | |||
| Differential pressure | |||
| (Delta-P): |