(32 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
The device description and intended use clearly state that it is a surgical face mask designed to protect healthcare personnel from microorganisms and fluids, not to treat a disease or condition.
No
The device is a surgical face mask, which is a barrier intended to protect against the transfer of microorganisms, not to diagnose a medical condition.
No
The device description clearly states it is a physical surgical mask made of multiple layers of non-woven polypropylene, indicating it is a hardware device.
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 masks are for protecting healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask and its materials. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases.
The device is a physical barrier intended for personal protection, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The disposable surgical face masks are intended to be worn to protect 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 provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
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)
The subject device was tested and conformed to 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.
Benchtop Performance Testing (Table 2):
- Level 3 Fluid Resistance Performance ASTM F1862: Pass (30-31 Out of 32 pass at 160 mmHg)
- Particulate Filtration Efficiency ASTM F2299: Pass (98.62-99.34%)
- Bacterial Filtration Efficiency ASTM F2101: Pass (99.5 - 99.1%)
- Differential Pressure ASTM F2100: Pass (3.92 - 4.78 mmH20/cm2)
- Class 1 Flammability 16 CFR 1610: Pass (Class 1, Did Not Ignite (DNI))
Biocompatibility testing was performed in accordance with ISO 10993-1:2018 (Table 3):
- Cytotoxicity - ISO 10993-5: Pass (non-cytotoxic)
- Skin Sensitization - ISO 10993-10: Pass (non-sensitizing)
- Skin Irritation - ISO 10993-10: Pass (non-irritating)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: 30-31 Out of 32 pass at 160 mmHg
Particulate Filtration Efficiency: 98.62-99.34%
Bacterial Filtration Efficiency: 99.5 - 99.1%
Differential Pressure: 3.92 - 4.78 mmH20/cm2
Flammability: Class 1, Did Not Ignite (DNI)
Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2022
Xinxiang Kangbeier Medical Technology Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213920
Trade/Device Name: Kangbeier Surgical Mask (Model: KBR-1001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 14, 2021 Received: December 15, 2021
Dear Prithul Bom:
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.
For Clarence W. Murray, III, PhD 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) K213920
Device Name Kangbeier Surgical Mask (Model: KBR-1001)
Indications for Use (Describe)
The disposable surgical face masks are intended to be worn to protect 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 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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510(k) SUMMARY K213920
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER
Xinxiang Kangbeier Medical Technology Co., Ltd. East Mancun Industrial District, Changyuan, Henan 48105 China Tel: +86-13341254319 Fax: N/A
| Contact Person: | Shaoju Tian |
|---|---|
| Date Prepared: | December 8, 2021 |
II. SUBJECT DEVICE
| Device Trade Name: | Kangbeier Surgical Mask (Model: KBR-1001) |
|---|---|
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Device Panel: | General Hospital |
| Product Classification Code: | FXX |
lll. PREDICATE DEVICE
| Predicate Manufacturer: | DemeTECH Corporation |
|---|---|
| Predicate Trade Name: | DemeMASK |
| Predicate 510(k): | K201479 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
V. INDICATIONS FOR USE
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 provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
4
| Device | Subject Device -
Kangbeier Surgical Mask
(Model: KBR-1001) | Predicate Device -
DemeMASK (K201479) | Result |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Manufacturer | Xinxiang Kangbeier
Medical Technology Co.,
Ltd. | DemeTECH Corporation | N/A |
| 510K Number | TBD | K201479 | N/A |
| Product Common Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Identical |
| Trade Name | Kangbeier Surgical Mask
(Model: KBR-1001) | DemeMASK Surgical Mask | N/A |
| Product Code | FXX | FXX | Identical |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Identical |
| Intended Use | 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
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
provided non- sterile. | Identical |
| Model | 3 Ply, Ear Loops, Flat-Pleated
Style | 3 Ply, Ear Loops or Tie-On | No tie-on
option for
subject device |
Table 1 is continued on page 2
5
| Materials | |||
|---|---|---|---|
| Outer Facing | |||
| Layer | Spun-Bond Polypropylene | Spun-Bond Polypropylene | Similar |
| Middle Layer | Melt-Blown Polypropylene | Melt-Blown Polypropylene Filter | Similar |
| Inner Facing Layer | Spun-Bond Polypropylene | Spun-Bond Polypropylene | Similar |
| Nose Piece | Galvanized wire coated with | ||
| polyethylene | Single Galvanized Wire, Coated | ||
| By PE | Similar | ||
| Ear Loops | Nylon & polyurethane | Not made with natural rubber latex | Similar |
| Color | Blue | White | Subject device |
| includes blue | |||
| colorant | |||
| Dimension (Width) | $9.2 cm \pm 0.2 cm$ | $9.5 cm \pm 1.0 cm$ | More narrow |
| tolerance for subject | |||
| device | |||
| Dimension | |||
| (Length) | $17.8 cm \pm 0.2 cm$ | $17.5 cm \pm 1.0 cm$ | More narrow |
| tolerance for subject | |||
| device | |||
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 3 | Same |
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VII. NON-CLINICAL DATA
The subject device was tested and conformed to 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 summary of the benchtop performance testing results is provided below in Table 2 along with the acceptance criteria.
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Level 3 Fluid | |||
| Resistance | |||
| Performance ASTM | |||
| F1862 | Resistance to Fluid | 29 Out of 32 pass at 160 | |
| mmHg | Pass | ||
| 30-31 Out of 32 pass at 160 mmHg | |||
| LOT #1, 30/32 passed, @ 160 mmHg | |||
| LOT #2 30/32 passed, @ 160 mmHg | |||
| LOT #3 31/32 passed, @ 160 mmHg | |||
| Particulate Filtration | |||
| Efficiency ASTM | |||
| F2299 | Particulate Filtration | ||
| Efficiency | ≥ 98% | Pass | |
| 98.62-99.34% | |||
| LOT #1 AVE Filtration Efficiency ≥ 98% | |||
| LOT #2 AVE Filtration Efficiency ≥ 98% | |||
| LOT #3 AVE Filtration Efficiency ≥ 98% | |||
| Bacterial Filtration | |||
| Efficiency ASTM | |||
| F2101 | Bacterial Filtration Efficiency | ≥ 98% | Pass |
| 99.5 - 99.1% | |||
| LOT #1 AVE Filtration Efficiency ≥ 98% | |||
| LOT #2 AVE Filtration Efficiency ≥ 98% | |||
| LOT #3 AVE Filtration Efficiency ≥ 98% | |||
| Differential Pressure | |||
| ASTM F2100 | Differential Pressure |