(336 days)
Not Found
No
The device description and performance metrics relate to the physical properties and filtration capabilities of a disposable medical mask, with no mention of AI or ML.
No.
The intended use of the device, a medical mask, is for protection against microorganisms and fluids, not for the treatment or diagnosis of a disease or condition.
No
The device description clearly states it is a "Disposable Medical Mask" intended for protection from transfer of microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like layers of polypropylene, ear loops, and a nose piece, indicating it is a physical medical device, not software-only.
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, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, materials, dimensions). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are relevant to a medical device providing a physical barrier, not an IVD.
In summary, the Disposable Medical Masks described are a medical device intended for personal protection and infection control, not an in vitro diagnostic device used for testing biological samples.
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
FXX
Device Description
The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.
50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.
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 Performance Testing:
- Resistance to penetration by synthetic blood (ASTM F1862): 3 non-consecutive lots, 32 samples per lot, AQL 4%. Result: Pass (Level 2: 29 out of 32 passed in 120 mmHg).
- Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299): 3 non-consecutive lots, 32 samples per lot, AQL 4%. Result: Pass (Level 2: ≥ 98%).
- Bacterial filtration efficiency (ASTM F2101-19): 3 non-consecutive lots, 32 samples per lot, AQL 4%. Result: Pass (Level 2: ≥ 98%).
- Differential pressure (MIL-M-36954): 3 non-consecutive lots, 32 samples per lot, AQL 4%. Result: Pass (Level 2:
§ 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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2021
Yangzhou Runyi Arts & Crafts CO., LTD. % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 32500 China
Re: K203112
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 13, 2021 Received: September 13, 2021
Dear Helen Nan:
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 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, Ph.D. 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
Indications for Use
510(k) Number (if known) K203112
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 201 Subpart D)Over-The-Counter Use (21 CFR 201 Subpart C) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
K203112 510(k) Summary (As required by 21 CFR 807.92)
1.0 Submitter Information
| Company: | YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. |
|---|---|
| Address: | 4.NO.87 West Heye Road HanJiang District |
| Yangzhou,Jiangsu,225008,CHINA | |
| Phone: | 086-514-82082789 |
| Contact Person: | Li Yu |
| Title: | Legal Person |
| E-mail: | yzsunnytoys@aliyun.com |
| • Date of Preparation: September 15, 2021 |
2.0 Device Information
| Trade/Device Name: | Disposable Medical Mask |
|---|---|
| Model: | RYSM001 |
| Regulation Description: | Surgical apparel |
| Device: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class II |
3.0 Predicate Device Information
| Trade/Device Name: | Single-use Medical Face Mask |
|---|---|
| 510k Number: | K203591 |
| Submitter: | Conod Medical Co., Limited |
4.0 Device Description
The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.
50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.
4
YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
5.0 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.
| Device | Predicate Device | Proposed Device | Compariso
n |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Manufacturer | Conod Medical Co.,
Limited | YANGZHOU RUNYI
ARTS & CRAFTS
CO., LTD. | N/A |
| 510K Number | K203591 | K203112 | N/A |
| Trade/Device
Name | Single-use Medical
Face Mask | Disposable Medical
Mask | N/A |
| Product Code | FXX | FXX | Same |
| Classification | Class II
(21 CFR 878.4040) | Class II
(21 CFR 878.4040) | Same |
| Indications
for Use | The Single-use
Medical 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. | 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. | Same |
| | Material | | |
| Outer Facing
Layer | Spunbond
Polypropylene | Spunbond
Polypropylene | Same |
| Middle Layer | Melt Blown | Melt Blown | Same |
| YANGZHOU RUNYU ARTS & CRAFTS CO., LTD. | | | |
| | Polypropylene
Filter | Polypropylene
Filter | |
| Inner Facing
Layer | Spunbond
Polypropylene | Spunbond
Polypropylene | Same |
| Nose Piece | Malleable aluminum
wire | Polyethylene | Different |
| Mask Style | Flat pleated | Flat pleated | Same |
| Design feature | Earloop, Tie Coverall,
3 layers | Earloop, 3 layers | Same |
| Ear loops/Ties | Ear loops: Polyester
Tie tapes: Spun-bond
Polypropylene | Ear loops: Spandex
and nylon | Different |
| Color | Blue | Blue | Same |
| Dimension
(Length ×
Width) | Earloop:
17.5 cm × 9.5 cm
16.5 cm × 9.0 cm
14.5 cm × 9.5 cm
Tie Coverall:
17.5 cm × 9.5 cm | Earloop:
14 cm × 9 cm | Similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100
Level | Level 2 | Level 2 | Same |
| | Non-Clinical Performance Testing | | |
| Fluid
Resistance
Performance
ASTM F1862 | 32 Out of 32 pass at
120 mmHg
(Level 2 Fluid
Resistance) | 32 Out of 32 pass at
120 mmHg
(Level 2 Fluid
Resistance) | Same |
| Particulate
Filtration
Efficiency
ASTM
F2299 | Average 99.80% | ≥99% | Similar |
| Bacterial
Filtration
Efficiency | Average 99.77% | ≥99% | Similar |
6.0 Summary of Comparison and Technological Characteristics
5
YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
6
| YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. | |||||||
|---|---|---|---|---|---|---|---|
| ---------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| ASTM
| F2101 | |||
|---|---|---|---|
| Differential | |||
| Pressure | |||
| (Delta P) | |||
| MIL-M- | |||
| 36954C | Average | ||
| $4.01 \text{ mmH2O/cm}^2$ | $ASTM F1862 | Testing the efficiency | |
| of resistance to | |||
| penetration by | |||
| synthetic blood. | Level 2: 29 out of 32 | ||
| passed in 120 mmHg |
3 non-consecutive
lots, 32 samples
per lot, AQL 4% | Pass |
| Sub-micron
particulate filtration
efficiency at
0.1 micron
ASTM F2299 | Testing the efficiency
of the filter material in
capturing aerosolized
particles smaller than
one micron. | Level 2: ≥ 98%
3 non-consecutive
lots, 32 samples
per lot, AQL 4% | Pass |
| Bacterial filtration
efficiency
ASTM F2101-19 | Testing the
effectiveness of
medical face mask
material in preventing | Level 2: ≥ 98%
3 non-consecutive
lots, 32 samples | Pass |
8
| | the passage of
aerosolized bacteria. | per lot, AQL 4% | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------|
| Differential
pressure MIL-M-
36954 | Measuring the
pressure of dropping
across a medical face
mask material. | Level 2: