(203 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 is a medical mask intended for infection control and protection from transfer of microorganisms, not for treating a disease or condition.
No
Explanation: The document describes a Disposable Medical Mask intended for protection against the transfer of microorganisms, body fluids, and particulate material. Its function is to provide a barrier and does not involve diagnosing medical conditions or diseases.
No
The device description clearly outlines a physical, multi-layered mask made of materials like polypropylene, spandex, nylon, and iron wire, with specific dimensions and physical performance testing. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the Disposable Medical Mask is intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing: The device description and performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, pressure resistance, fluid resistance, flame spread, biocompatibility). There is no mention of testing biological samples or diagnosing any condition.
The intended use and function of this device are purely for personal protective equipment (PPE) and infection control through physical barrier protection, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable Medical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter.
Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
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
patient and 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:
- Bacterial filtration efficiency (BFE) according to ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019. Test results: 32/32 Passed at ≥98%.
- Differential pressure (Delta-P) according to EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019. Test results: 32/32 Passed at
§ 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, there is a seal with an eagle and text around it, representing the Department of Health & Human Services - USA. To the right, there is a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue.
April 5, 2021
Dongguan Runlin Medical Supplies Technology Co., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202655
Trade/Device Name: Disposable Medical Mask (Model: Rlp001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 5, 2021 Received: March 9, 2021
Dear Cassie Lee:
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 de vice, 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 53 1 -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/cdrl-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-ind-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,
Bifena O
For 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202655
Device Name Disposable Medical Mask (Model: Rlp001)
Indications for Use (Describe)
The Disposable Medical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided nonsterile.
| 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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510(k) Summary for K202655
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Dongguan Runlin Medical Supplies Technology Co., LTD Establishment Registration Number: 3016965344 Address: No.6, longzhou wei street, liaobu town, dongguan city, guangdong province, China. Contact Person: Weiming Chen Email: weiming c@126.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: September 9, 2020 Revision date: April 3, 2021
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Medical Mask Model Name: Rlp001 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
4. Predicate Device Information
Sponsor: 3M Health Care
4
| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
Trade Name: 3M™ High Fluid- Resistant Procedure Mask Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
5. Device Description
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter.
Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
6. Intended Use / Indications for Use
The Disposable Medical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
7. Comparison of Technological Characteristics
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| --------------------------- | ---------------- | ------------------ | --------- |
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Elements of | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Comparison | |||
| Company | Dongguan Runlin Medical | ||
| Supplies Technology Co., LTD | 3M Health Care | -- | |
| 510 (k) | K202655 | K191355 | -- |
| Trade Name | Disposable Medical Mask | 3M™ High Fluid- Resistant | |
| Procedure Mask | -- | ||
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 | ||
| CFR878.4040) | Class II Device, FXX (21 | ||
| CFR878.4040) | Same | ||
| Intended use | The Disposable Medical Mask 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 potential exposure to | |||
| blood and body fluids. The face | |||
| mask is single use, disposable | |||
| device, provided non-sterile. | 3M™ High Fluid- Resistant | ||
| Procedure Mask 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 potential exposure to | |||
| blood and body fluids. This is a | |||
| single use, disposable device, | |||
| provided non-sterile. | Same | ||
| Material | |||
| Outer facing | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Polypropylene coated iron wire | Polyethylene coated steel wire | Different |
| Note 1 | |||
| Ear loops | Spandex and nylon | Spandex elastic cord | |
| (polyurethane core with | |||
| polyethylene terephthalate | |||
| /nylon cover) | Different | ||
| Note 1 | |||
| Design | |||
| features | Color: Blue (Outer) | Color: Green (Outer) | Different |
| Note 1 |
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| Sponsor: | Dongguan Runlin Medical Supplies Technology Co., LTD |
|---|---|
| Subject Device: | Disposable Medical Mask (Model: Rlp001) |
| Document Name: | 510(k) Summary |
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification | |||
| and | |||
| Dimension | Length: 17.5cm±1cm | ||
| Width: 9.5cm±1cm | Length: 17.5cm±0.5cm | ||
| Width: 9.0cm±0.75cm | Different | ||
| Note 1 | |||
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance | |||
| Testing | Level 3 | Level 3 | Same |
| Fluid | |||
| Resistance | |||
| Performance | 32/32 Passed at 160 mmHg | ||
| ASTM F1862 | 32/32 Passed at 160mm Hg | ||
| ASTM F1862 | Same | ||
| Particulate | |||
| Filtration | |||
| Efficiency | 32/32 Passed at ≥98% | ||
| ASTM F2299-03 | 32/32 Passed at ≥98% @ 0.1 | ||
| Micron ASTM F2299 | Same | ||
| Bacterial | |||
| Filtration | |||
| Efficiency | 32/32 Passed at ≥98% | ||
| ASTM F2101-14 | 31/32 Passed at ≥98% | ||
| ASTM F2101 | Same | ||
| Differential | |||
| Pressure | 32/32 Passed at |