(396 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of surgical masks, with no mention of AI or ML technology.
No
The device is a surgical mask intended for infection control by preventing the transfer of microorganisms and particulate material, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions or diseases.
No
The device description clearly details physical components made of materials like polypropylene non-woven fabric, Melt blown non-woven fabric, polypropylene, Malleable polyethylene wire, and Spandex, indicating it is a physical medical device (surgical masks) and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction of the masks (layers, materials, wearing methods). There is no mention of reagents, assays, or any components used for testing samples from the human body.
- Performance Studies: The performance studies focus on the physical barrier properties of the masks (filtration efficiency, pressure resistance, blood penetration) and biocompatibility. These are relevant to the mask's function as a physical 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 information about a patient's health status.
In summary, the surgical masks described are intended to prevent the transmission of substances, not to diagnose a condition. This aligns with the definition of a medical device that provides a physical barrier, not an in vitro diagnostic device.
No.
A Predetermined Change Control Plan (PCCP) is not mentioned or indicated anywhere in the provided clearance letter. PCCPs are specifically authorized by the FDA for certain medical devices to allow for pre-specified modifications without requiring a new 510(k) submission. This document describes a standard 510(k) clearance for surgical masks.
Intended Use / Indications for Use
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.
The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold 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
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 conducted to verify that the proposed device met all design specifications. 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:
- A ASTM F2100-20, 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;
-
EN 14683: 2019, Requirements and Test Methods of Differential pressure of Medical Face Mask:
-
ASTM F2101-19, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299-17, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
Key results from performance tests (sample sizes of 32/lot for 3 non-consecutive lots for each model):
- Bacterial Filtration Efficiency (ASTM F2101-19): Both models passed. ZSFM 23 achieved 99.9% for all lots (Level 3 requirement is ≥98%). ZSFM 24 achieved 99.9% for all lots (Level 1 requirement is ≥95%).
- Differential Pressure (EN 14683:2019, Annex C): Both models passed. ZSFM 23 results were 4.86, 4.83, 4.87 (Level 3 requirement is
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2022
Wuhan Zonsen Medical Products Co., Ltd Cynthia Ye General Manager No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, Hubei 431000 China
Re: K213601
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 11, 2022 Received: November 21, 2022
Dear Ms. Ye:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213601
Device Name Surgical Mask
Indications for Use (Describe)
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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
510(K) Summary
510k Number: K213601 Revised date: May 12, 2022
A. Applicant:
Wuhan Zonsen Medical Products Co., Ltd Address: No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China Contact Person: Cynthia Ye Tel: +86- 27-82737771
Submission Correspondent: Primary contact: Cynthia Ye Tel: +86-27-82737771 Email: Cynthia@zonsenmed.com Secondary contact: Linna Ye Tel: +86-27-82737772 Email: registration01@zonsenmed.com
B. Device:
Trade Name: Surgical Mask Common Name: Surgical Mask Model(s): ZSFM23, ZSFM24
Regulatory Information Classification Name: Surgical Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K211827 Level 3 Fluid Resistant Procedure/Surgical Mask Zhejiang Lanhine Medical Products LTD.
D. Indications for use :
The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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.
E. Device Description:
4
Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China
The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.
The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
| Comparison
Component | Proposed Device | Predicate Device | Comparis
on | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------|
| Manufacturer | Wuhan Zonsen Medical Products
Co., Ltd | Zhejiang Lanhine Medical
Products LTD. | / | |
| 510K number | K213601 | K211827 | / | |
| Device name | Surgical Mask | Level 3 Fluid Resistant
Procedure/Surgical Mask | / | |
| Classification | Class II Device, FXX (21
CFR878.4040) | Class II Device, FXX (21
CFR878.4040) | Same | |
| Comparison
Component | Proposed Device | Predicate Device | Comparis
on | |
| Indications for use | The Surgical Masks (model:
ZSFM 23, ZSFM 24) are intended
to be worn to protect both the
patient and healthcare personnel
from transfer of microorganisms,
body fluids and particulate
material. These 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 Level 3 Fluid
Resistant Procedure/Surgical
Mask (model: 15604F, 15704F)
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 a single
use, disposable device(s),
provided non-sterile. | Same | |
| Ear loop model and
tie-on model | Model: ZSFM 23, Tie-On, Flat
Pleated, 4 layers
Model: ZSFM 24, Ear Loops, Flat
Pleated, 3 layers | Ear Loops, Tie-On, Flat
Pleated, 3 layers | Similar | |
| | | | Same | |
| | Outer
layer | Polypropylene non-woven fabric | Non-woven Fabric
(Polypropylene) | Same |
| | Middle
layer(s) | Polypropylene Melt blown
non-woven fabric | Melton brown Fabric
(Polypropylene) | Same |
| Mater
ial | Inner
layer | Polypropylene non-woven fabric | Non-woven Fabric
(Polypropylene) | Same |
| | Nose clip | Malleable polyethylene | Polypropylene coating
iron | Similar |
| | Tie-on
bands | Polypropylene non-woven fabric | Non-woven Fabric
(Polypropylene) | Same |
| | Ear loops | Spandex | Polyurethane | Same |
| Color | Blue | Blue | Same | |
| Dimension | 17.5 cm +/- 0.5 cm | 17.5 cm +/- 0.5 cm | Same | |
| | 9.5 cm +/- 0.5 cm | 9.5 cm +/- 0.5 cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single use; disposable | Single use; disposable | Same | |
| ASTM F2100 Level | Model: ZSFM 23, Level 3 | Level 3 | Same | |
| Comparison
Component | Proposed Device | Predicate Device | Comparis
on | |
| | Model: ZSFM 24, Level 1 | | Similar | |
| Biocompatibility | Meet ISO10993-5
and ISO10993-10 | ISO10993 | Same | |
F. Comparison with predicate device
5
Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan, Hubei, China
6
G. Summary of Non-Clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar 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:
- A ASTM F2100-20, 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;
-
EN 14683: 2019, Requirements and Test Methods of Differential pressure of Medical Face Mask:
-
ASTM F2101-19, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299-17, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
| Test results of Proposed device | |||||
|---|---|---|---|---|---|
| Performance | Purpose | Requirement | Surgical Mask | ||
| (model: ZSFM 23) | Surgical Mask | ||||
| (model: ZSFM 24) | |||||
| Bacterial | |||||
| Filtration | |||||
| Efficiency | |||||
| ASTM | |||||
| F2101-19 | Assess the | ||||
| performance of | |||||
| a mask to | |||||
| penetration by a | |||||
| prepared solution | |||||
| with known | |||||
| concentration of an | |||||
| indicator bacterial | |||||
| organism | Level 1: ≥95% |
Level 3: ≥98% | PASS
3 non-consecutive lots
tested, using a sample
size of 32/ lot.
Lot 1: 99.9%;
Lot 2: 99.9%;
Lot 3: 99.9%; | PASS
3 non-consecutive lots
tested, using a sample
size of 32/ lot.
Lot 1: 99.9%;
Lot 2: 99.9%;
Lot 3: 99.9%; | |
| | Differential
Pressure | Assess the
performance of | Level 1: