(74 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 technology.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a face mask intended to protect against the transfer of microorganisms and body fluids, which is a preventative measure, not a treatment.
No
The device is a medical mask designed to protect against the transfer of microorganisms and body fluids. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components made of polypropylene and aluminum wire, indicating it is a hardware 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 from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's ability to filter particles and fluids, its breathability, flammability, and biocompatibility. These are all relevant to a physical barrier device, not an IVD.
- 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The AIC 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. The 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 nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The AIC Disposable Medical Masks are Blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
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 Data:
Test item: Bacterial filtration efficiency; Test Standard/method: ASTM F2101-19; Pass criteria: >= 98%; Test results: 99.3%; Conclusion: Pass
Test item: Differential pressure (Delta-P); Test Standard/method: ASTM F2100-19; Pass criteria: = 98%; Test results: 99.9%; Conclusion: Pass
Test item: Flammability; Test Standard/method: 16 CFR 1610; Pass criteria: Class 1 (>= 3.5 seconds); Test results: Test Article ignited, but extinguished or did not ignite.; Conclusion: Pass
Biocompatibility testing:
Cytotoxicity (ISO10993-5): Under the conditions of the study, the proposed device extract demonstrated evidence of potential cytotoxicity. Acute systemic toxicity was conducted to further assess biocompatibility.
Skin Irritation (ISO10993-10): Under the conditions of the study, the proposed device extract was determined to be non - irritating.
Skin Sensitization (ISO10993-10): Under the conditions of the study, the proposed device extract was determined to be non - sensitizing.
Acute Toxicity (ISO10993-11): Under the conditions of the study, the proposed device extract was determined to be non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency: 99.3%
Differential pressure (Delta-P): 4.40 mmH2O/cm²
Fluid Resistance Performance: 96 out of 96 Pass at 160 mmHg
Particulate Filtration Efficiency: 99.9%
Flammability: Class 1
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows 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.
March 12, 2021
The Aleen International Corporation % Diana Lam Regulatory Affairs Consultant Duocare, LLC 370 W. Grand Blvd. Suite 110 Corona, California 92882
Re: K203775
Trade/Device Name: AIC disposable medical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 28, 2020 Received: December 28, 2020
Dear Diana Lam:
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 and Part 809: 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 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.
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
2
Indications for Use
510(k) Number (if known) K203775
Device Name AIC Disposable Medical Mask
Indications for Use (Describe)
The AIC 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. The 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 nonsterile.
| Type of Use (Select one or both, as applicable) | Routine Use Per 31 CFR 331.3(a)(2) - Payments Data File Comparison Under 31 CFR 331.3(a)(2) - Screening |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
| | 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
K203775
Date Summary Prepared:
March 10, 2021
Applicant:
The Aleen International Corporation
Address: Jiutian Green Science and Technology Industrial Park, Heyuan High-Tech Zone, Heyuan, Guangdong, China 517000
Contact:
Can Huang
The Aleen International Corporation
Email: chuang@aleenic.com
Phone: (+001) 626-620-0184
Correspondent Contact:
Diana Lam,
DuoCare, LLC
info@@duocarepro.com
Device Information:
Device Name: AIC Disposable Medical Mask
Trade Name: AIC Disposable Medical Mask
Common Name: Disposable Medical Mask
Device Classification Name: Surgical Apparel
Classification Regulation Number: 21 CFR 878.4040
Device Classification: Class II
Classification Product Code: FXX
4
Predicate Device
| Predicate Device | Disposable Surgical Face Mask | K153496 | Xiantao Rayxin Medical
Products Co., Ltd. | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Item Name | Subject device | Predicate Device | Comparison | |
| Device name | AIC Disposable Medical | Disposable Surgical | - | |
| | Mask | Face Mask | | |
| Manufacturer | The Aleen International | Xiantao Rayxin Medical | - | |
| | Corporation | Products Co., ltd. | | |
| 510(K) No. | K203775 | K153496 | - | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Classification Name | Surgical Apparel | Surgical Apparel | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | FXX | FXX | Same | |
| Indications for use | The AIC 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. The 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(s),
provided non-sterile. | Same | |
| Device Description | The AIC Disposable
Medical Masks are Blue
and white color, and Flat
Pleated type mask,
utilizing Tie-On or Ear
Loops way for wearing,
and they all has Nose
Piece design for fitting
the facemask around the
nose.
The blue colorant is
polypropylene (PP)
master batch.
The proposed device(s)
are manufactured with
three layers, the inner
and outer layers are
made of spun-bond
polypropylene, and the
middle layer is made of | The proposed device(s)
are Blue color, and Flat
Pleated type mask,
utilizing Tie-On or Ear
Loops way for wearing,
and they all has Nose
Piece design for fitting
the facemask around the
nose.
The blue colorant is
polypropylene (PP)
master batch.
The proposed device(s)
are manufactured with
three layers, the inner
and outer layers are
made of spun-bond
polypropylene, and the
middle layer is made of
melt blown polypropylene
filter | Same | |
| | | melt blown polypropylene
filter.
The model of proposed
device, tie-on, is held in
place over the user's
mouth and nose by four
ties welded to the
facemask. The tie is
made of spun-bond
polypropylene.
The model of proposed
device, ear loops, is held
in place over the user's
mouth and nose by two
elastic ear loops welded
to the facemask. The
elastic ear loops are not
made with natural rubber
latex.
The nose piece
contained in the
proposed device(s) is in
the layers of facemask to
allow the user to fit the
facemask around their
nose, which is made of
malleable aluminum wire.
The proposed device(s)
are sold non-sterile and
are intended to be single
use, disposable device | The model of proposed
device, tie-on, is held in
place over the user's
mouth and nose by four
ties welded to the
facemask. The tie is
made of spun-bond
polypropylene.
The model of proposed
device, ear loops, is held
in place over the user's
mouth and nose by two
elastic ear loops welded
to the facemask. The
elastic ear loops are not
made with natural rubber
latex.
The nose piece
contained in the
proposed device(s) is in
the layers of facemask to
allow the user to fit the
facemask around their
nose, which is made of
malleable aluminum wire.
The proposed device(s)
are sold non-sterile and
are intended to be single
use, disposable device. | |
| Ear loop model and
tie-on model | | Ear Loops, Tie-On, Flat | Ear Loops, Tie-On, Flat
Pleated, 3 layers | Same |
| | Outer
layer | Pleated, 3 layers
Spun-bond
polypropylene | Spun-bond
polypropylene | |
| | Middle
layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | |
| Mater-
ial | Inner
layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same |
| | Ties | Spun-bond
polypropylene | Spun-bond
polypropylene | |
| | Nose piece | Malleable aluminum wire | Malleable aluminum wire | |
| Ear loops | | Polyester | Polyester | |
| | Mask cover
width | $9.5 \pm 1.0$ cm | $9.5 \pm 1.0$ cm | Same |
| | Mask cover
length | $17.5 \pm 1.0$ cm | $17.5 \text{ cm }\pm 1.0$ cm | Same |
| Dimension | Single ear loop Length for Ear Loops style | $18.0 \pm 1.0$ cm | $17.0 \pm 1.0$ cm | Similar |
| | Single tie Length for Tie-On style | $38.5 \pm 5.0$ cm | $40 \pm 1.0$ cm | Similar |
| | Nose piece length | $10.5\pm 1.0$ cm | $11.0\pm 1.0$ cm | Similar |
| Actual performance values (Average) | Bacterial filtration efficiency | 99.3% (3 lots, 32 samples/lot) | 98.7% | Similar |
| | Differential pressure (Delta-P) | 4.40 mmH2O/cm² (3 lots, 32 samples/lot) | 4.2 mmH2O/cm² | Similar |
| | Fluid Resistance Performance | 96 out of 96 Pass at160 mmHg (3 lots, 32 samples/lot) | 32 out of 32 pass at 120 mmHg | Same |
| | Particulate Filtration Efficiency | 99.9% (3 lots, 32 samples/lot) | 98.46% | Similar |
| | Flammability | Class 1 (3 lots, 32 samples/lot) | Class 1 | Same |
| Biocompatibility | Cytotoxicity | Under the conditions of the study, the proposed device extract demonstrated evidence of potential cytotoxicity | Under the conditions of the study, not cytotoxicity effect | Different |
| | Skin Irritation | Under the conditions of the study, the proposed device extract was determined to be non - irritating | Under the conditions of the study, not an irritant | Same |
| | Skin Sensitization | Under the conditions of the study, the proposed device extract was determined to be non - sensitizing | Under conditions of the study, not a sensitizer. | Same |
| | Acute Toxicity | Under the conditions of the study, the proposed device extract was determined to be non-toxic | - | Different, product safety concern was addressed |
| Color | | Blue (outside), White (inside) | Blue | Same |
| OTC use | | Yes | Yes | Same |
| Single use | | Yes | Yes | Same |
| Sterility | | Non-sterile | Non-sterile | Same |
| ASTM F2100 Level | | Level 3 | Level 2 | Different |
Description of Device
The AIC Disposable Medical Masks are blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
Indications for use
The AIC 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. The 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.
5
Technological Characteristics Comparison
6
7
8
Non-Clinical performance Data
| Test item
(ASTM Level 3) | Test Standard/
method | Pass criteria | Test results | Conclusion |
|--------------------------------------|--------------------------|----------------------------|-----------------------------------------------------------------|------------|
| Bacterial filtration
efficiency | ASTM F2101-
19 | ≥ 98% | 99.3% | Pass |
| Differential pressure
(Delta-P) | ASTM F2100-
19 |