(169 days)
Not Found
No
The summary describes a standard surgical mask made of non-woven fabrics with ear loops and a nose piece. There is no mention of any computational or analytical capabilities, let alone AI or ML. The performance studies are standard material and barrier tests.
No.
The device is a surgical mask intended for protection against the transfer of microorganisms, body fluids, and particulate matter, not for treating a disease or condition.
No
This device is a surgical mask intended for protection and infection control by preventing the transfer of microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product (surgical masks made of non-woven fabric with ear loops and a nose piece) and its material composition. There is no mention of software components or 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, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical construction and materials of the mask, designed to create a physical barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health or condition. IVDs are specifically designed for this purpose.
- Performance Studies and Key Metrics: The performance studies and metrics listed (fluid resistance, filtration efficiency, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask, not diagnostic accuracy.
In summary, this device is a medical mask intended for infection control through physical protection, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.
The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.
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
Not Found
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
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
- ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency A (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
- A Bench Testing for the performance of Dimensions.
No clinical study is included in this submission.
Key Results:
- Fluid Resistance Performance ASTM F1862: 160 mmHg (Proposed), 120 mmHg (Predicate), 160 mmHg (ASTM F2100 Requirements for Level 3 Classification)
- Particulate Filtration Efficiency ASTM F2299: 98.02 - 98.80% (Proposed), 98.46% (Predicate), ≥ 98% (ASTM F2100 Requirements for Level 3 Classification)
- Bacterial Filtration Efficiency ASTM F2101: 99.6 - 99.7% (Proposed), 98.7% (Predicate), ≥ 98% (ASTM F2100 Requirements for Level 3 Classification)
- Differential Pressure: 3.20 - 4.18 mmH2O/cm2 (Proposed), 4.2 mmH2O/cm2 (Predicate),
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2021
Tianjin Teda Jinshan Easy Packing Manufacture Co., LTD % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K202323
Trade/Device Name: Disposable Medical Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 12, 2020 Received: August 17, 2020
Dear Ray Wang:
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.
1
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); 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 medical devices and radiation-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,
For CAPT Elizabeth Claverie, M.S. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Disposable Medical Surgical Masks
Indications for Use (Describe)
The Disposable Medical Surgical Masks is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device(s), provided non-sterile.
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)
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3
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202323
-
- Date of Preparation:2021/02/02
-
- Sponsor Identification
Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. No.3 Wuhai Road, Jinhai Economic Development Area, Tianjin, China 301600
Contact Person: Hui Liu Position: International Trading Manager Tel: +86-22-68228888 Fax: +86-22-68225555 Email: jinshan@tedajinshan-bag.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Disposable Medical Surgical Masks Common Name: Surgical Face Mask
Regulatory Information Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
Indication for use Statement:
The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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.
Device Description
The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.
The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.
5
-
న్. Identification of Predicate Device(s)
Predicate Device K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., ltd. -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
-
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
-
MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
-
ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency A (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
-
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
A 16 CFR 1610, Standard for the Flammability of clothing textiles;
-
A Bench Testing for the performance of Dimensions.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Summary of the Technological Characteristics of the Device 8.
| ITEM | Proposed Device K202323 | Predicate Device K153496 | Remark | |
|---|---|---|---|---|
| Intended Use | The Disposable Medical Surgical Masks is | |||
| intended to be worn to protect both the | ||||
| patient and healthcare personnel from the | ||||
| transfer of microorganisms, body fluids, | ||||
| and particulate material. The Single-Use | ||||
| Surgical Mask with Ear Loop 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 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(s), provided | ||||
| non-sterile. | SAME | |||
| Basic Design | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | SAME | |
| Materials | Outer Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | Analysis |
| Middle Layer | Melt blown non-woven fabric | Melt blown polypropylene filter | ||
| Inner Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | ||
| Nose Piece | PE + iron wire | Malleable aluminum wire | ||
| Ear Loops | Polyurethane fibre + Nylon | Polyester | ||
| Color | Blue | Blue | SAME | |
| Dimension (Length) | $17.5 cm +/- 5%$ | $17.5 cm +/- 1cm$ | Similar | |
| Dimension (Width) | $10 cm +/- 5%$ | $9.5 cm +/- 1cm$ | ||
| OTC use | Yes | Yes | SAME | |
| Single Use | Yes | Yes | SAME | |
| Sterile | No | No | SAME | |
| ASTM F2100 Level | Level 3 | Level 2 | Analysis |
Table 1 General Comparison
Table 2 Performance Characteristic Comparison
| ITEM | Proposed
K202323 | Predicate
K153496 | ASTM F2100
Requirements for
Level 3 Classification | Remark |
|----------------------------------------------------|-----------------------|----------------------|----------------------------------------------------------|----------|
| Fluid Resistance
Performance ASTM
F1862 | 160 mmHg | 120 mmHg | 160 mmHg | Analysis |
| Particulate Filtration
Efficiency ASTM
F2299 | 98.02 - 98.80% | 98.46% | ≥ 98% | |
| Bacterial Filtration
Efficiency ASTM
F2101 | 99.6 - 99.7% | 98.7% | ≥ 98% | |
| Differential Pressure | 3.20 - 4.18 mmH2O/cm2 | 4.2 mmH2O/cm2 |