(36 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The "Intended Use / Indications for Use" states that the device is for protection from transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. It does not mention treating or preventing a disease, which are characteristics of a therapeutic device.
No.
The device is a surgical face mask, intended to protect from microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (layers of polypropylene, ear loops, nose piece) and the performance studies are focused on physical properties and biocompatibility, not software functionality.
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, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Disposable Surgical Face Mask" intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing on Samples: The device does not perform any tests on samples taken from a patient. Its function is external and protective.
- Intended Use: The intended use is for "infection control practices to reduce the potential exposure to blood and body fluids," which is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask, not any components or processes related to analyzing biological samples.
The information provided focuses on the physical and filtration properties of the mask, as well as its biocompatibility, which are relevant for a protective barrier device, not an IVD.
N/A
Intended Use / 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 nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any 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
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)
Benchtop Performance Testing (Non-Clinical):
Resistance to Penetration by Synthetic Blood ASTM F1862: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Particulate Filtration Efficiency ASTM F2299: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Bacterial Filtration Efficiency ASTM F2101: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98% - ASTM F2101. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Differential Pressure EN 14683:2019: Three non-sequential lots of 32 (total of 96, AQL 4.0) 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
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September 10, 2021
ReMade USA LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K212451
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 4, 2021 Received: August 5, 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
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Indications for Use
510(k) Number (if known) K212451
Device Name Surgical Mask
Indications for Use (Describe)
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 nonsterile.
| Type of Use (Select one or both, as applicable) | Renovation that is Part of CER 331 Subpart D Construction that is CER 331 Subpart O |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------- |
__ 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 K212451
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR $807.92:
SUBMITTER .
ReMade USA LLC 2915 E Washington Blvd Los Angeles, CA 90023 USA Tel: +1.323.578.5448 Fax: N/A
Contact Person: David Durst Date Prepared: May 21, 2021
DEVICE II.
| Name of Device: | Surgical Mask |
|---|---|
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FXX |
. PREDICATE DEVICE
Predicate Manufacturer: Predicate Trade Name: Predicate 510(k):
DemeTECH Corporation Deme MASK Surgical Face Mask K201479
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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 nonsterile.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device:
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | ReMade USA LLC | DemeTECH Corporation | - |
| 510K Number | K212451 | K201479 | - |
| Product | |||
| CommonName | SURGICAL MASK | DemeMASK Surgical Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| 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. | 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. | Same | ||
| Model | 3 Ply, Ear Loops, Flat-Pleated | ||
| Style | 3 Ply, Ear Loops/Tie-on, Flat- | ||
| PleatedStyle | Similar | ||
| Materials | |||
| Outer | |||
| Facing | |||
| Layer | Spunbond Polypropylene 25gsm | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene | ||
| Filter 25gsm | Melt Blown PolypropyleneFilter | Same | |
| Inner Facing | |||
| Layer | Spunbond Polypropylene 25gsm | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanized Iron Wire, | ||
| coated with Polypropylene | |||
| $3.0mm\pm1.0mm$ Length/1 | |||
| $\pm0.1mm$ Thick/ $0.5\pm0.01mm$ | |||
| Diameter | Galvanized wire coated with PE | ||
| (Dimensions Unknown) | Similar | ||
| Ear Loops | 80% Nylon; 20% Spandex | ||
| Length: $4.0mm\pm0.15$ , Thickness: | |||
| $1.0mm\pm0.15mm$ | Polyester spandex blend | Similar | |
| Color | Blue | White | Different |
| Dimension | |||
| (Width) | $9.5 cm \pm 1cm$ | $9.5cm \pm 1cm$ | Same |
| Dimension | |||
| (Length) | $17.5 cm \pm 1cm$ | $17.5cm \pm 1cm$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 | |||
| Level | Level 3 – ASTM F2100-19 | Level 3 – ASTM F2100-19 | Same |
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VII. SUMMARY of NON-CLINICAL PERFORMANCE TESTING
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.
| Item | Purpose | Acceptance Criteria | Subject Device - ReMade
Surgical Mask |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Level 3
Resistance to
Penetration by
Synthetic Blood
STM F1862 | The purpose of
this testing is to
demonstrate
the Resistance
to Penetration
by Synthetic
Blood ASTM
F1862 of the
subject device. | 29 Out of 32
pass at 160 mmHg | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at 160mmHg
Lot 1: 32/32 passed.
Lot 2: 32/32 passed.
Lot 3: 32/32 passed |
Table 2 – Benchtop Performance Testing
6
| Particulate
Filtration
Efficiency ASTM
F2299 | The purpose of
this testing is to
demonstrate the
Particulate
Filtration
Efficiency ASTM
F2299 of the
subject device. | ≥ 98% | Three non-sequential lots of 32
(total of 96, AQL 4.0) passed at
≥98%
Lot 1: 32/32 passed.
Lot 2: 32/32 passed.
Lot 3: 32/32 passed |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial
Filtration
Efficiency ASTM
F2101 | The purpose of this
testing is to
demonstrate the
Bacterial Filtration
Efficiency ASTM
F2101 of the subject
device. | ≥ 98% | Three non-sequential lots of 32
(total of 96, AQL 4.0) passed at
≥98% - ASTM F2101
Lot 1: 32/32 passed.
Lot 2: 32/32 passed.
Lot 3:32/32 passed |
| Differential
Pressure EN
14683:2019 | The purpose
of this testing
is to
demonstrate
the
Differential
Pressure EN
14683:2019
of the subject
device. |