← Product Code [FXX](/productcode/FXX) · K203775
# AIC disposable medical mask (K203775)
_The Aleen International Corporation · FXX · Mar 12, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K203775
## Device Facts
- **Applicant:** The Aleen International Corporation
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Mar 12, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## 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.
## Device Story
AIC Disposable Medical Mask; flat pleated design; three-layer construction (inner/outer spun-bond polypropylene; middle melt-blown polypropylene filter). Features malleable aluminum nose piece; available in tie-on or elastic ear loop configurations. Used in clinical settings for infection control; worn by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. Provides barrier protection; single-use; non-sterile. No electronic components or software.
## Clinical Evidence
No clinical data. Bench testing only. Performance metrics: Bacterial filtration efficiency 99.3%; Differential pressure 4.40 mmH2O/cm²; Fluid resistance 96/96 pass at 160 mmHg; Particulate filtration efficiency 99.9%; Flammability Class 1.
## Technological Characteristics
Three-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (middle). Malleable aluminum nose piece. Ear loops (polyester/elastic) or spun-bond polypropylene ties. ASTM F2100 Level 3 performance. Non-sterile. No energy source or software.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Disposable Surgical Face Mask ([K153496](/device/K153496.md))
## Submission Summary (Full Text)
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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.
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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
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# 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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# 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
www.aleenic.com
## 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
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### 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.…
---
**Source:** [https://fda-staging.innolitics.com/device/K203775](https://fda-staging.innolitics.com/device/K203775)
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