(56 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended to protect against transferring microorganisms and body fluids, not to treat or cure a disease or condition.
No
The device description and intended use clearly state that it is a surgical mask designed to protect from transfer of microorganisms and particulate materials, not to diagnose any condition. The "Summary of Performance Studies" and "Key Metrics" sections focus on filtration efficiency, fluid resistance, and flammability, which are performance characteristics of a protective barrier, not diagnostic capabilities.
No
The device description clearly outlines a physical product (a surgical mask) made of specific materials and with physical components (ear loops, nose piece). It is not software.
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 against the transfer of microorganisms, body fluids, and particulate materials. 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). It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and metrics focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are not diagnostic performance metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
- Lack of IVD-related terms: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, assays, or any other terms associated with in vitro diagnostics.
In summary, the device is a physical barrier intended for protection, not a test performed on samples outside the body to diagnose a condition.
N/A
Intended Use / Indications for Use
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
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
patient and healthcare workers
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)
The subject device was evaluated for safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
Biocompatibility testing:
- ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation Of Medical Devices Part 10: Tests O For Irritation And Skin Sensitization.
Key results from performance testing:
- Fluid Resistance Performance (ASTM F 1862):
- Lot 1: 32 out of 32 pass at 160 mmHg
- Lot 2: 32 out of 32 pass at 160 mmHg
- Lot 3: 31 out of 32 pass at 160 mmHg
- Result: PASS (Acceptance Criteria: 29 out of 32 pass at 120 mmHg)
- Particulate Filtration Efficiency (ASTM F 2299):
- Lot 1: 99.80%
- Lot 2: 99.83%
- Lot 3: 99.87%
- Result: PASS (Acceptance Criteria: >= 98% PFE)
- Bacterial Filtration Efficiency (ASTM F 2101):
- Lot 1: 99.8%
- Lot 2: 99.8%
- Lot 3: 99.8%
- Result: PASS (Acceptance Criteria: > 98% BFE)
- Flammability (16 CFR 1610):
- Lot 1: DNI
- Lot 2: DNI
- Lot 3: DNI
- All 3 Lots met Class 1 Flammability standards.
- Result: PASS (Acceptance Criteria: Class 1)
- Differential Pressure (EN 14683:2019):
- Lot 1: 4.8 mmHg
- Lot 2: 4.7 mmHg
- Lot 3: 4.6 mmHg
- Result: PASS (Acceptance Criteria:
§ 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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July 28, 2023
Original Mattress Factory Inc. Nathan Elseser Director of Personal Protective Equipment 4930 State Road Cleveland, Ohio 44134
Re: K231618
Trade/Device Name: 3 Layer Surgical Mask (134252531) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2023 Received: June 2, 2023
Dear Nathan Elseser:
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.
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
1
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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231618
Device Name 3 Layer Surgical Mask
Indications for Use (Describe)
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
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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510(k) Summary
1. Submitter Information:
Company Name: The Original Mattress Factory, Inc. d.b.a. Original Medical Supply
Address: 4930 State Road, Cleveland, Ohio, USA 44134
Phone Number: 216-661-8388
Contact Person: Nathan Elseser
Email: Nelseser@OriginalMattress.com
Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical Face Mask |
| Trade Name: | 3 Layer Surgical Mask |
| Classification: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |
Predicate Device Information:
| Sponsor: | Premier Guard USA LLC |
|---|---|
| Address: | 460 Briarwood Drive, Suite 400 |
| Common Name: | Surgical Face Mask |
| Trade Name: | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask |
| 510(k) Number: | K202595 |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |
2. Device Description
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
4
3. Intended Use
When properly worn, the 3 Layer Surgical Mask are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
4. Test Summary
Subject device has been evaluated for safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- . During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
- o ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation Of Medical Devices Part 10: Tests O For Irritation And Skin Sensitization.
5
5. Summary of Comparison and Technological Characteristics:
Table 1 - Elements of Comparison
| Elements of Comparison | Subject Device | Predicate Device (K202595) | Comments | |
|---|---|---|---|---|
| PRODUCT CODE | FXX | FXX | SAME | |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | SAME | |
| Class | II | II | SAME | |
| Product Name | 3 Layer Surgical Mask | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | – | |
| GENERAL COMPARISON | ||||
| Intended Use | When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only. | The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from the 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 | |
| Composite | Flat Pleated, 3 Layers, ear loops | Flat Pleated, 3 Layers, ear loops | SAME | |
| Material | ||||
| S | Outer Facing | Spun-Bond | ||
| Polypropylene | Spun-Bond | |||
| Polypropylene | SAME | |||
| Middle | Melt Blown | |||
| Polypropylene | ||||
| fiber | Melt Blown fiber | SAME | ||
| Inner Facing | Spun-Bond | |||
| Polypropylene | Spun-Bond | |||
| Polypropylene | SAME | |||
| Nose Piece | Polyethylene | |||
| coated annealed | ||||
| carbon steel | ||||
| wire | Polyethylene coated | |||
| annealed carbon | ||||
| steel wire | SAME | |||
| Ear Loops | Polyester, | |||
| Spandex | Nylon, Spandex | Different¹ | ||
| Color | Blue, White | Blue | SIMILAR | |
| Dimensions (width) | 95.0mm (+/- | |||
| 5.0mm) | 95.0mm | SAME | ||
| Dimensions (length) | 175mm (+/- | |||
| 5.0mm) | 175mm | SAME | ||
| Use | Single Use | Single Use | SAME | |
| Sterility | Non-Sterile | Non-Sterile | SAME | |
| ASTM F2100 Level | Level 3 | Level 3 | SAME | |
| Fluid Resistance Performance ASTM F | ||||
| 1862 | Lot 1: 32 out of | |||
| 32 pass at 160 | ||||
| mmHg | ||||
| Lot 2: 32 out of | ||||
| 32 pass at 160 | ||||
| mmHg | ||||
| Lot 3: 31 out of | ||||
| 32 pass at 160 | ||||
| mmHg | Pass at 160mmHg | Both Predicate | ||
| and Subject | ||||
| Device PASS | ||||
| Particulate Filtration Efficiency ASTM F | ||||
| 2299 | Lot 1: 99.80% | |||
| Lot 2: 99.83% | ||||
| Lot 3: 99.87% | ≥ 98% | Both Predicate | ||
| and Subject | ||||
| Device PASS | ||||
| Bacterial Filtration Efficiency ASTM F 2101 | Lot 1: 99.8% | |||
| Lot 2: 99.8% | ||||
| Lot 3: 99.8% | $\ge 98%$ | Both Predicate | ||
| and Subject | ||||
| Device PASS | ||||
| Differential Pressure (Delta P) EN | ||||
| 14683:2019+AC : 2019 | Lot 1: 4.8 mmHg | |||
| Lot 2: 4.7 mmHg | ||||
| Lot 3: 4.6 mmHg | 98% BFE | PASS | ||
| Flammability 16 | ||||
| CFR 1610 | The purpose of this test | |||
| method is to determine the | ||||
| flammability characteristics of | ||||
| the mask as specified in 16 | ||||
| CFR 1610. Materials in the | ||||
| construction of face masks | ||||
| shall meet the requirements | ||||
| of Class 1, Normal | ||||
| Flammability specified by 16 | ||||
| CFR part 1610. | Lot 1: DNI | |||
| Lot 2: DNI | ||||
| Lot 3: DNI | ||||
| All 3 Lots met Class 1 | ||||
| Flammability | ||||
| standards | Class 1 | PASS | ||
| Differential | ||||
| Pressure EN | ||||
| 14683:2019 | The purpose of this test | |||
| method is to determine the | ||||
| overall breathability through | ||||
| the mask barrier in terms of | ||||
| mmH2O/cm³. The mask | ||||
| surface is subjected to | ||||
| constant air flow of 8.0 L/min | ||||
| and the pressure differential | ||||
| is measured. | Lot 1: 4.8mmHg | |||
| Lot 2: 4.7mmHg | ||||
| Lot 3: 4.6mmHg |