(192 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
A surgical mask is a protective barrier device, not intended for treating or diagnosing a medical condition. Its purpose is to prevent the transfer of microorganisms and particulate material.
No
A surgical mask is used to protect the wearer and others from the transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device description clearly outlines physical components (layers of material, ear loops, nose piece) and the performance studies are based on testing these physical properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting the wearer and patient from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose piece). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency (particulate and bacterial), breathability (differential pressure), flammability, and biocompatibility. These are all relevant to the mask's function as a barrier, not as a diagnostic tool.
- Lack of IVD Indicators: 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 surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.
Product codes
FXX
Device Description
The device is a surgical mask which can be described as non-sterile, single-use, 3 layer, flat-pleated style with ear loops and a nose piece. The outer layer of the surgical mask consists of blue nonwoven spunbond polypropylene and the inner layer consists of carded non-woven polyethylene/polyester. The middle layer consists of melt-blown polypropylene filter. The ear loops consists of 140D nylon and spandex elastic string not made with natural rubber latex. The nose piece is made with white galvanized iron with polyethylene coating.
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:
The proposed Surgical Mask was tested to ASTM F2100-19 Level 1 requirements and pursuant to the FDA Guidance "Surgical Mask - Premarket Notification [510(k)] Submission".
Table 4 - Performance Testing Summary
-
Fluid Resistance Performance ASTM F1862
- Lot Number: K-1820-01, Sample Size: 32 surgical masks. Results: Pass, 29 of 32 Passed at 80 mmHg.
- Lot Number: J-0720-02, Sample Size: 32 surgical masks. Results: Pass, 30 of 32 Passed at 80 mmHg.
- Lot Number: J-0920-03, Sample Size: 32 surgical masks. Results: Pass, 29 of 32 Passed at 80 mmHg.
- Pass Criteria: Fluid resistant, pass at 80 mmHg.
-
Particulate Filtration Efficiency ASTM F2299/F2299M-03
- Lot Number: J-0620-01, Sample Size: 32 surgical masks. Results: Pass, >=97.6%.
- Lot Number: J-0720-02, Sample Size: 32 surgical masks. Results: Pass, >=98.8%.
- Lot Number: J-0920-03, Sample Size: 32 surgical masks. Results: Pass, >=96.8%.
- Pass Criteria: >=95%.
-
Bacterial Filtration Efficiency ASTM F2101-01(2019)
- Lot Number: J-0620-01, Sample Size: 32 surgical masks. Results: Pass, >=99.63%.
- Lot Number: J-0720-02, Sample Size: 32 surgical masks. Results: Pass, >=99.74%.
- Lot Number: J-0920-03, Sample Size: 32 surgical masks. Results: Pass, >=99.57%.
- Pass Criteria: >=95%.
-
Differential Pressure (Delta-P) ASTM F2100-19 (EN 14683)
- Lot Number: J-0620-01, Sample Size: 32 surgical masks. Results: Pass, Average 3.1 mmH2O/cm², All
§ 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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April 11, 2021
Customfab, INC. % Laura Nygard RAQA Consultant, Lean RAQA Lean RAQA, LLCX 12602 N Summer Wind Drive Marana, Arizona 85658
Re: K203012
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 8, 2021 Received: March 9, 2021
Dear Laura Nygard:
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/cdrl/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); 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,
Ryan Ortega -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K203012
Device Name Surgical Mask
Indications for Use (Describe)
The Surgical Mask is intended to be worn to protent and healtheare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce of the wearer to blood and body fluids. This is a single use device, provided non-sterile.
Type of Use (Select one or both, as applicable)
Over-The-Counter Use (21 CFR 801 Subpart C) _ Prescription Use (Part 21 CFR 801 Subpart D)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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1. Applicant Information
Company Name Establishment Registration Number Phone Number Company Street Address Fax Number City State Country Zip Code
CUSTOM FAB, INC. 2031000 (714) 891-9119 7345 Orangewood Ave 714-891-1699 GARDEN GROVE CA US 92841
2. Contact Person
| Full Name | Erentia Gillmer |
|---|---|
| Job Title | Brand Director |
| Phone | (714) 891-9119 X 231 |
| erentia@customfabusa.com |
3. Correspondent Information
| Full Name | Laura Nygard |
|---|---|
| Job Title | RAQA Consultant, Lean RAQA |
| Phone | (734) 807-1282 |
| lauran@leanraqa.com |
4. Date of Preparation
Date of Preparation
04/05/2021
5. Device Information
Table 1 - Device Information
| Trade Name | Surgical Mask |
|---|---|
| Common or Usual Name | Surgical Apparel |
| Classification Name | 21 CFR 878.4040 |
| Regulatory Class | 2 |
| Product Code | FXX |
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6. Predicate Devices
Table 2 - Predicate Device(s)
| Predicate Type | 510(k) Number | Name of Device | Name of Manufacturer |
|---|---|---|---|
| Primary Device | K201729 | Medical Mask | Zhende Medical Co., Ltd |
7. Device Description
The device is a surgical mask which can be described as non-sterile, single-use, 3 layer, flat-pleated style with ear loops and a nose piece. The outer layer of the surgical mask consists of blue nonwoven spunbond polypropylene and the inner layer consists of carded non-woven polyethylene/polyester. The middle layer consists of melt-blown polypropylene filter. The ear loops consists of 140D nylon and spandex elastic string not made with natural rubber latex. The nose piece is made with white galvanized iron with polyethylene coating.
8. Intended Use/ Indications for Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.
9. Comparison of Technological Characteristics
| Device | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | CUSTOMFAB, INC. | Zhende Medical Co., Ltd | N/A |
| 510(k) Number | K203012 | K201729 | N/A |
| Product Common Name | Surgical mask | Medical Face Mask | Similar |
| Product Code | FXX | FXX | Same |
| Classification | Class II 21 CFR 878.4040 | Class II 21 CFR 878.4040 | Same |
| Surgical apparel. | Surgical apparel. | ||
| The Surgical Mask is | The Medical Masks are | Same | |
| intended to be worn to | intended to be worn to | ||
| protect both the patient | protect both the patient | ||
| and healthcare personnel | and healthcare personnel | ||
| from transfer of | from transfer of | ||
| microorganisms, body | microorganisms, body | ||
| fluids and particulate | fluids and particulate | ||
| material in infection | material. These face masks | ||
| control practices to | are intended for use in | ||
| reduce the potential | infection control practices to | ||
| exposure of the wearer to | reduce the potential exposure | ||
| blood and body fluids. | of the wearer to blood and | ||
| This is a single use | |||
| device, provided non- | body fluids. This is a single | ||
| sterile. | use, disposable device(s), | ||
| provided non-sterile. | |||
| Model | 1 model of the level 1 | ||
| surgical mask. | L1171801 | N/A | |
| Materials | |||
| Device | Surgical Mask | Surgical Mask | Same |
| Outer Facing Layer | Blue non-woven | ||
| spunbond | |||
| polypropylene | Spun-bond polypropylene | Similar | |
| Middle Layer | Melt-blown | ||
| polypropylene | Melt blown | ||
| polypropylene filter | Same | ||
| Inner Facing Layer | Non-woven | ||
| polyester/polypropylene | Spun-bond polypropylene | Similar | |
| Nose Piece | White galvanized steel | ||
| with | |||
| polyethylene coating | Malleable polypropylene | ||
| with iron wire | Similar | ||
| Ear Loops | Nylon and spandex | ||
| elastic | |||
| String | Polyester and spandex | Similar | |
| Color(s) | Blue and White | Blue | Similar |
| Specifications and Dimensions | |||
| Dimension (width) | 9.5 +/- 0.25 cm | 9.5 +/- 1.0 cm | Similar |
| Dimension (length) | 17.5 +/- 0.25 cm | 18.0 +/- 1.0 cm | Similar |
| Mask Style | |||
| Shape | Flat-pleated | Flat-pleated | Same |
| Design Features | |||
| Ear Loops or Ties | Ear loops | Ear loops | Same |
| Nose | |||
| Piece | |||
| (if | |||
| applicable) | Yes | Yes | Same |
| ASTM F2100 Level | Level 1 | Level 1 | Same |
| Use | Single Use | Single Use | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Performance Data | |||
| Standard | Proposed Device | Predicate Device | Remarks |
| Fluid Resistance | |||
| Performance ASTM F1862 | Fluid resistant, pass at 80 | ||
| mmHg | Fluid resistant, pass at 80 | ||
| mmHg | Same | ||
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299/F2299M-03 | ≥95% | ≥95% | Same |
| Bacterial Filtration | |||
| Efficiency ASTM F2101- | |||
| 01(2019) | ≥95% | ≥95% | Same |
| Differential Pressure (Delta- | |||
| P) ASTM F2100-19 (EN |
16 CFR Part 1610 |