(237 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable medical mask, with no mention of AI or ML.
No.
The device, a disposable medical mask, is intended for infection control by preventing the transfer of microorganisms and fluids, not for treating a disease or condition.
No
The device, a disposable medical mask, is intended for protection from transfer of microorganisms, body fluids and particulate material, not for diagnosing conditions.
No
The device description clearly outlines a physical product (three-layer, flat-folded masks with ear loops and nose clamp) made of materials like polypropylene, polyester, and spandex. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose clamp).
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility).
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This mask does not perform any such analysis of biological samples.
The information provided describes a medical device that acts as a physical barrier, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Medical 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp.
The Medical Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Polyester and spandex.
The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene with iron wire.
The Medical Masks will be provided in blue. The medical masks are provided as non-sterile and are intended to be single use, disposable 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with 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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks-Requirements and Test Methods;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand 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;
Key results from performance testing:
- Fluid Resistance ASTM F1862: 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested. Acceptance Criteria (level 1): 29 out of 32 pass at 80 mmHg. Result: PASS.
- Particulate Filtration Efficiency ASTM F2299: Lot1:97.63%, Lot2:97.08%, Lot3:97.05%. 32 samples each lot. Acceptance Criteria (level 1): > 95%. Result: PASS.
- Bacterial Filtration Efficiency ASTM F2101: Lot1:99.88%, Lot2:99.89%, Lot3:99.89%. 32 samples each lot. Acceptance Criteria (level 1): > 95%. Result: PASS.
- Differential Pressure (Delta P) EN 14683 Annex C: Lot1:3.17, Lot2:3.03, Lot3:3.05. 32 samples each lot. Acceptance Criteria (level 1):
§ 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
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March 25, 2021
Hangzhou Qianzhiya Sanitary Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202133
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 8, 2021 Received: March 8, 2021
Dear Ivy 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.
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 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,
Ryan Ortega, PhD Acting 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
2
Indications for Use
510(k) Number (if known) K202133
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable Medical 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.
| 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
K202133 510(K) Summary
Date of preparation: 2021-03-23
A. Applicant:
Applicant: HANGZHOU QIANZHIYA SANITARY PRODUCTS CO., LTD Address: No.88 Fengwang Road, Economic Development Zone Tonglu, Tonglu County, Hangzhou, 311500 Zhejiang, P.R.China
Contact Person: Yu Shao Tel: +86-571-69910779 E-mail: 494365004@qq.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Medical Mask Common Name: Disposable Surgical Mask Model(s): Plane Ear-loop type
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K110455 Kimberly-Clark KC100 Mask
D. Intended use of the device:
The Disposable Medical 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.
4
This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp.
The Medical Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Polyester and spandex.
The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene with iron wire.
The Medical Masks will be provided in blue. The medical masks are provided as non-sterile and are intended to be single use, disposable devices.
F. Technological Characteristic Comparison
| Device | Proposed Device | Predicate Device | Conclusion | |
|---|---|---|---|---|
| Manufacturer | HANGZHOU QIANZHIYA | |||
| SANITARY PRODUCTS CO., | ||||
| LTD | Kimberly-Clark | - | ||
| 510K number | K202133 | K110455 | - | |
| Model Name | Disposable Medical Mask | Kimberly-Clark KC100 Mask | - | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| Intended use | The Disposable Medical 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. | The Kimberly-Clark KC100 | |||
| Procedure Mask(s) is 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. The | ||||
| Kimberly-Clark KC100 | ||||
| Procedure Mask(s) is a single | ||||
| use, disposable devices, | ||||
| provided non-sterile. | Similar | |||
| Model | Plane Ear-loop type | Ear Loops, Tie-On, Flat | ||
| Pleated, 3 layers | - | |||
| M | ||||
| at | Outer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
Table 1 General Comparison
5
HANGZHOU QIANZHIYA SANITARY PRODUCTS CO., LTD
| eri
al | Middle
layer | Melt blown polypropylene filter | Melt blown polypropylene | Same |
|-----------|-----------------------|---------------------------------|--------------------------|-----------|
| | Inner
layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose clip | polypropylene with iron wire | NA | - |
| | Ear loops | Polyester, Spandex | Polyester/lycra knitted | Different |
| | Color | Blue | Variety (include blue) | Different |
| | Dimension
(Length) | $17.5\pm1$ cm | $165\pm19$ mm | Different |
| | Dimension
(Width) | $9.5\pm1$ cm | $102 \pm 19$ mm | Different |
| | OTC use | Yes | Yes | Same |
| | Sterility | Non-Sterile | Non-Sterile | Same |
| | Use | Single Use, Disposable | Single Use, Disposable | Same |
| | ASTM F2100
level | Level 1 | Level 1 | Same |
| | Biocompatibili
ty | ISO10993 | ISO10993 | Same |
From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
Also, the dimension of the mask was different from the predicate device. The performance testing was conducted and although the test results are not identical to each other, they are similar and they both meet the requirement of Level 2 medical mask according to the ASTM F 2100.
G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with 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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical
6
face masks to penetration by particulates using latex spheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles; >
| Item | Results | Acceptance Criteria
(level 1) | Interpretation |
|--------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------|----------------|
| Fluid Resistance
Performance ASTM
F1862 | 32 out of 32 per lot pass
at 80 mmHg, 3 non-
consecutive lots tested | 29 out of 32 pass at 80
mmHg | PASS |
| Particulate Filtration
Efficiency ASTM F2299 | Lot1:97.63%
Lot2:97.08%
Lot3:97.05%
32 samples each lot | > 95% | PASS |
| Bacterial Filtration
Efficiency ASTM F2101 | Lot1:99.88%
Lot2:99.89%
Lot3:99.89%
32 samples each lot | > 95% | PASS |
| Differential Pressure
(Delta P) EN 14683
Annex C | Lot1:3.17
Lot2:3.03
Lot3:3.05
32 samples each lot |