(239 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a face mask intended to protect against transfer of microorganisms and body fluids, which is a preventive measure, not a therapeutic one.
No
This device is described as a face mask intended for protection and infection control, not for diagnosing any medical conditions.
No
The device description clearly outlines physical components (polypropylene layers, nosepiece, ear loops) and the performance studies focus on physical properties and filtration efficiency, not software functionality.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical construction of the mask (layers, nosepiece, ear loops). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a personal protective equipment (PPE) designed to prevent the spread of infectious agents through physical filtration and barrier properties. This falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask 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 potential exposure to blood and body fluids. These face masks are single-use, disposable devices, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The United Sewing High Fluid Resistant Disposable Face Mask is a single use, disposable, nonsterile face mask intended to cover the nose and mouth of the wearer. The subject device consists of 3 layers with the outer and inner layer made with polypropylene spunbound material and middle layer made with polypropylene melt blown material, The device has a bendable nosepiece made with Polyethylene coated single wire, and ear loops made from nylon and spandex material. This device will be provided over the counter under the trade names United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask for marketing purpose. This device is not made with 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
Not Found
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 Testing:
- Fluid Resistance: ASTM F1862M-17; 32/32 Passed at 160 mmHg.
- Bacterial Filtration Efficiency (BFE): EN 14683:2019, Annex C ASTM F2101-19; 32/32 Passed at 99.62%.
- Differential Pressure (Air Exchange): EN 14683:2019, Annex C ASTM F2101-19; 32/32 passed at 4.8 mm H2O/cm².
- Flammability: 16 CFR 1610; 32/32 Passed (≥3.5 seconds) Class 1 Pass.
- Particulate Filtration: ASTM F2299; 32/32 Passed at 99.76%.
- Biocompatibility Testing (for Surface Device category, Skin Contact, ≤24h duration):
- In vitro Cytotoxicity Test per ISO 10993-5:2009.
- Skin Sensitization Tests per ISO 10993-10:2010.
- Skin Irritation Tests per ISO 10993-10:2010.
The tests demonstrated that the subject device is biocompatible and safe for its intended use.
Clinical Testing:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Particulate Filtration Efficiency (PFE): 99.76% (ASTM F2299)
- Fluid Resistance: Pass at 160 mm Hg (ASTM F1862)
- Bacterial Filtration Efficiency (BFE): 99.62% (ASTM F2101)
- Differential Pressure: 4.8 mm H2O/cm² (EN 14683:2019 and ASTM F2101-19)
- Flammability: Class 1, 16 CFR 1610
- Biocompatibility: Non-cytotoxic, non-irritating, and non-sensitizing
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 13, 2021
United Sewing Automation Inc. % Heather Hatcher Regulatory Scientist Womble Bond Dickinson, US LLP One West Fourth Street Winston-Salem, North Carolina 27101
Re: K202697
Trade/Device Name: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 14, 2020 Received: September 16, 2020
Dear Heather Hatcher:
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 (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 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 Clarence W. Murray III, Ph.D. 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) K202697
Device Name
United Sewing High Fluid Resistant Disposable Face Mask United Sewing High Fluid Resistant Surgical Mask United Sewing High Fluid Resistant Procedure Mask
Indications for Use (Describe)
The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask 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 potential exposure to blood and body fluids. These face masks are single-use, disposable devices, 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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3
510(K) SUMMARY K202697
| Sponsor Information: | United Sewing Automation, Inc.
1772 N. Andy Griffith Parkway
Mount Airy, NC 27030 |
| ---------------------- | ----------------------------------------------------------------------------------------- |
|---|
-
Contact information: Benjamin Web Title: CEO Phone: (336) 710-2404 Email: ben@unitedsewinginc.com
Date of Summary Prepared: May 13, 2021 -
Common Name: Surgical Mask
-
Classification Name: Surgical Apparel
Proprietary Name: United Sewing High Fluid Resistant Disposable Face Mask United Sewing High Fluid Resistant Surgical Face Mask United Sewing High Fluid Resistant Procedure Face Mask
- Review Panel: General and Plastic Surgery
- Product Code: FXX
- Device Classification: Class II per 21 CFR §878.4040
- San-M Package Co., Ltd. Surgical Face Masks Predicate Device(s): (Ear loops and Tie-on) (K160269)
Intended Use/Indications for Use:
Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask 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 potential exposure to blood and body fluids.
The United Sewing High Fluid Resistant
4
These face masks are single-use, disposable devices, provided nonsterile.
Device Description:
The United Sewing High Fluid Resistant Disposable Face Mask is a single use, disposable, nonsterile face mask intended to cover the nose and mouth of the wearer. The subject device consists of 3 layers with the outer and inner layer made with polypropylene spunbound material and middle layer made with polypropylene melt blown material, The device has a bendable nosepiece made with Polyethylene coated single wire, and ear loops made from nylon and spandex material. This device will be provided over the counter under the trade names United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask for marketing purpose. This device is not made with natural rubber latex.
Comparison of Technological Characteristics between the subject and predicate devices:
Descriptions and comparisons of the United Sewing High Fluid Resistant Disposable Face Mask, and the same face mask that is marketed as the United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask, and predicate device features are presented in the Technological Characteristics Comparison Table.
| Item(s) | Subject Device
(K202697)
United Sewing High
Fluid Resistant
Disposable Face Mask,
also marketed under
trade names United
Sewing High Fluid
Resistant Surgical Face
Mask and United
Sewing High Fluid
Resistant Procedure
Face Mask | Predicate Device
(K160269)
San-M Package Co.,
Ltd. Surgical Face
Masks (Ear loops and
Tie-on) | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended
Use/Indications
for Use | The United Sewing High
Fluid Resistant
Disposable Face Mask,
also marketed under
trade names United
Sewing High Fluid
Resistant Surgical Face
Mask and United Sewing | The surgical face
masks are intended to
be worn to protect both
the patient and
healthcare personnel
from transfer of
microorganisms, body
fluids, and particulate | Similar |
| | High Fluid Resistant
Procedure Face Mask, is
intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body
fluids, and particulate
material. This face mask
is intended for use in
infection control practices
to reduce the potential
exposure to blood and
body fluids. This face
mask is a single-use,
disposable devices,
provided non-sterile. | 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. | |
| Outer Layer | Polypropylene,
Spunbound, 99.5% | Polypropylene | Same |
| Filter (Middle)
Layer | Polypropylene, Melt
Blown | Polypropylene
Spunbond;
Polypropylene
meltblown | Same |
| Inner Facing
Layer | Polypropylene,
Spunbound, 99.5% | Polypropylene thermal-
bonded | Same |
| Nose Piece | Polyethylene Coated
Single Wire, 10.16 cm | Polyethylene coated
steel wire | Same |
| Ear Loops | Nylon and Spandex, 12.7
cm each side | Polyester, polyurethane | Different* |
| Mask Color | White | Variety colors | Different* |
| Mask Style | Flat pleated | Flat pleated | Same |
| Multiple Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Length | 9.5 cm ± 0.5 cm | 90 mm ± 3 mm
92 mm ± 3 mm | Similar |
| Width | 17.5 ± 0.5 cm | 175 mm ± 5 mm
180 mm ± 5mm | Similar |
| Particulate
Filtration
Efficiency (PFE) | 99.76%
ASTM F2299 | Pass
ASTM F2299 | Similar |
| Fluid Resistance | Pass at 160 mm Hg
ASTM F1862 | Pass at 80-160 mm Hg
ASTM F1862 | Same |
| Bacterial Filtration
Efficiency (BFE) | 99.62%
ASTM F2101 | Pass at ≥98% | Same |
| | | ASTM F2101 | |
| Differential
Pressure | 4.8 mm H2O/cm²
EN 14683:2019 and
ASTM F2101-19 | Pass at ≤2.5 H2O/cm²
MIL-M36945C | Same |
| Flammability | Class 1, 16 CFR 1610 | Class 1, 16 CFR 1610 | Same |
| Biocompatibility | Non-cytotoxic, non-
irritating, and non-
sensitizing | Non-cytotoxic, non-
sensitizing, non-
irritating | Same |
| *Although the ear loop materials and color subject device are little difference with predicate
device, it meets the requirement of essential performance standard ISO 10993 and
performance testing. The differences between the predicate device and subject device will not
affect the safety and effectiveness of the subject device | | | |
5
6
A Summary of the Non-clinical Testing Conducted:
The United Sewing High Fluid Resistant Disposable Face Mask and United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask has met the standards listed in the table below:
| Title of Performance Test
[Performance Aspect] | Test Method | Test Method
Acceptance Criteria | Results
Pass |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------|------------------------------------------------|
| Resistance of Medical Face Mask to
Penetration by Synthetic Blood
(Horizontal Projection of Fixed Volume
at a Known Velocity)
[Fluid Resistance] | ASTM F1862M-
17 | Fluid resistant claimed
at 160 mm Hg | 32/32 Passed
at 160 mmHg |
| Medical face masks - Requirements
and test methods
Standard Test Method for Evaluating
the Bacterial Filtration Efficiency (BFE)
of Medical Face Mask Materials, Using
a Biological Aerosol of Staphylococcus
aureus
[Bacterial Filtration Efficiency] | EN 14683:2019,
Annex C
ASTM F2101-
19*‡ | Pass ≥98% | 32/32 Passed
at 99.62% |
| Medical face masks - Requirements
and test methods
(Differential Pressure) - Delta P test
[Air Exchange] | EN 14683:2019,
Annex C
ASTM F2101-19* | Pass