(192 days)
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.
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.
The provided document is a 510(k) premarket notification for a Surgical Mask. It details the device's characteristics and its comparison to a predicate device, focusing on non-clinical performance data to establish substantial equivalence.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | Fluid resistant, pass at 80 mmHg | Lot K-1820-01: Pass, 29 of 32 Passed at 80 mmHg Lot J-0720-02: Pass, 30 of 32 Passed at 80 mmHg Lot J-0920-03: Pass, 29 of 32 Passed at 80 mmHg |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 | ≥95% | Lot J-0620-01: Pass, ≥97.6% Lot J-0720-02: Pass, ≥98.8% Lot J-0920-03: Pass, ≥96.8% |
| Bacterial Filtration Efficiency | ASTM F2101-01(2019) | ≥95% | Lot J-0620-01: Pass, ≥99.63% Lot J-0720-02: Pass, ≥99.74% Lot J-0920-03: Pass, ≥99.57% |
| Differential Pressure (Delta-P) | ASTM F2100-19 (EN 14683) | <5.0 mmH2O/cm² | Lot J-0620-01: Pass, Average 3.1 mmH2O/cm² (All < 5.0 mmH2O/cm²) Lot J-0720-02: Pass, Average 3.5 mmH2O/cm² (All < 5.0 mmH2O/cm²) Lot J-0920-03: Pass, Average 4.1 mmH2O/cm² (All < 5.0 mmH2O/cm²) |
| Flammability | 16 CFR Part 1610 | Class 1 | Lot J-0620-01: Pass, 32 samples did not ignite Lot J-0720-02: Pass, 32 samples did not ignite Lot J-0920-03: Pass, 32 samples did not ignite |
| Biocompatibility (ISO 10993) | (Not directly specified in table, but listed) | Non-cytotoxic, Non-sensitizing, Non-irritating | The document states the device is "Non-cytotoxic, Non-sensitizing, Non-irritating," implying it meets these criteria. Specific test results are not detailed in the provided table but are asserted. |
2. Sample Size Used for the Test Set and the Data Provenance
- Fluid Resistance Performance: 32 surgical masks per lot, tested across 3 lots (K-1820-01, J-0720-02, J-0920-03).
- Particulate Filtration Efficiency: 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Bacterial Filtration Efficiency: 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Differential Pressure (Delta-P): 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Flammability: 32 samples per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
The data provenance is non-clinical performance data generated from laboratory testing of the device for various physical and biological properties. The document does not specify the country of origin where the testing was conducted, nor does it classify the data as "retrospective" or "prospective" in the context of clinical studies, as these are non-clinical lab tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the performance criteria of a surgical mask (e.g., filtration efficiency, fluid resistance) is established by industry standards (like ASTM F2100-19, ASTM F1862, ASTM F2299/F2299M-03, ASTM F2101-01, 16 CFR Part 1610, ISO 10993) and regulatory guidance, not by expert consensus on individual cases. The tests are objective measurements performed in laboratories.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. For objective laboratory performance tests of a surgical mask, there is no human interpretation or adjudication process in the same sense. The results are quantitative measurements against predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or decision support systems where human readers interpret medical images or data. The submitted device is a surgical mask and does not involve AI or human readers for its intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept applies to AI-driven devices. The surgical mask is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria of the surgical mask is based on established industry standards and regulatory requirements (e.g., ASTM standards, CFR regulations). These standards define the acceptable performance levels for specific physical and biological properties of surgical masks. The test results are objective measurements compared against these predefined numerical criteria.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical mask), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a surgical mask.
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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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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 1surgical mask. | L1171801 | N/A |
| Materials | |||
| Device | Surgical Mask | Surgical Mask | Same |
| Outer Facing Layer | Blue non-wovenspunbondpolypropylene | Spun-bond polypropylene | Similar |
| Middle Layer | Melt-blownpolypropylene | Melt blownpolypropylene filter | Same |
| Inner Facing Layer | Non-wovenpolyester/polypropylene | Spun-bond polypropylene | Similar |
| Nose Piece | White galvanized steelwithpolyethylene coating | Malleable polypropylenewith iron wire | Similar |
| Ear Loops | Nylon and spandexelasticString | 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 |
| NosePiece(ifapplicable) | 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 ResistancePerformance ASTM F1862 | Fluid resistant, pass at 80mmHg | Fluid resistant, pass at 80mmHg | Same |
| Particulate FiltrationEfficiencyASTM F2299/F2299M-03 | ≥95% | ≥95% | Same |
| Bacterial FiltrationEfficiency ASTM F2101-01(2019) | ≥95% | ≥95% | Same |
| Differential Pressure (Delta-P) ASTM F2100-19 (EN14683)16 CFR Part 1610 | <5.0 mmH20/cm² | <5.0 mmH20/cm² | Same |
| Class 1 | Class 1 | Same | |
| Biological Performance | |||
| Standard | Proposed Device | Predicate Device | Remarks |
| Biocompatibility (ISO 10993) | Non-cytotoxic, Non-sensitizing, Non-irritating | Non-cytotoxic, Non-sensitizing, Non-irritating | Same |
Table 3 - Comparison of Technological Characteristics
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10. Performance Data
Non-Clinical Performance Data 10.1
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
| Test Item | Test Method | Pass Criteria | Results |
|---|---|---|---|
| Lot Number:K-1820-01Sample Size:32 surgical masks | Fluid ResistancePerformance ASTMF1862 | Fluid resistant,pass at 80mmHg, | Pass,29 of 32 Passed at 80 mmHg |
| Lot Number:J-0720-02Sample Size:32 surgical masks | Pass,30 of 32 Passed at 80 mmHg | ||
| Lot Number:J-0920-03Sample Size:32 surgical masks | Pass,29 of 32 Passed at 80mmHg | ||
| Lot Number:J-0620-01Sample Size:32 surgical masks | Particulate FiltrationEfficiencyASTM F2299/F2299M-03 | ≥95% | Pass,≥97.6% |
| Lot Number:J-0720-02Sample Size:32 surgical masks | Pass,≥98.8% | ||
| Lot Number:J-0920-03Sample Size:32 surgical masks | Pass,≥96.8% | ||
| Lot Number:J-0620-01Sample Size:32 surgical masks | Bacterial FiltrationEfficiency ASTM F2101-01(2019) | ≥95% | Pass,≥99.63% |
| Lot Number:J-0720-02Sample Size:32 surgical masks | Pass,≥99.74% |
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| Lot Number:J-0920-03Sample Size:32 surgical masks | Pass,≥99.57% | ||
|---|---|---|---|
| Lot Number:J-0620-01Sample Size:32 surgical masks | Differential Pressure(Delta-P) ASTM F2100-19 (EN 14683) | <5.0 mmH20/cm² | Pass,Average 3.1 mmH20/cm²All < 5.0 mmH20/cm² |
| Lot Number:J-0720-02Sample Size:32 surgical masks | Pass,Average 3.5 mmH20/cm²All < 5.0 mmH20/cm² | ||
| Lot Number:J-0920-03Sample Size:32 surgical masks | Pass,Average 4.1mmH20/cm²All< 5.0 mmH20/cm² | ||
| Lot Number:J-0620-01Sample Size:32 surgical masks | 16 CFR Part 1610 | Class 1 | Pass,32 samples did not ignite |
| Lot Number:J-0720-02Sample Size:32 surgical masks | Pass,32 samples did not ignite | ||
| Lot Number:J-0920-03Sample Size:32 surgical masks | Pass,32 samples did not ignite |
10.2 Clinical Performance Data
No Clinical study is included in this submission
11. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.