Who is the manufacturer of Sparta 3-Ply Surgical Disposable Face Mask?

Sparta East, LLC filed the 510(k) submission for Sparta 3-Ply Surgical Disposable Face Mask (K220378).

What is the FDA product code for Sparta 3-Ply Surgical Disposable Face Mask?

FXX. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Sparta 3-Ply Surgical Disposable Face Mask?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sparta 3-Ply Surgical Disposable Face Mask?

Disposable Surgical Mask (K202463); 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On (K202096).

Who can help prepare an FDA 510(k) submission like Sparta 3-Ply Surgical Disposable Face Mask?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sparta 3-Ply Surgical Disposable Face Mask

K220378 · Sparta East, LLC · FXX · Jun 30, 2022 · General, Plastic Surgery

Device Facts

Record ID	K220378
Device Name	Sparta 3-Ply Surgical Disposable Face Mask
Applicant	Sparta East, LLC
Product Code	FXX · General, Plastic Surgery
Decision Date	Jun 30, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Indications for Use

The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device

Device Story

Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated, single-use, non-sterile mask. It features ear loops and a nose piece for securing to the user's face. The device consists of three layers: an outer spunbond polypropylene layer, a middle melt-blown polypropylene filter layer, and an inner spunbond polypropylene layer. It is used in clinical settings by healthcare professionals and patients to provide a physical barrier against microorganisms, body fluids, and particulates. The device is worn over the nose and mouth. It functions as a protective mask to reduce potential exposure to blood and body fluids during infection control practices.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683), Synthetic Blood Penetration Resistance (ASTM F1862), Latex Particle Challenge (ASTM F2299), and Flammability (16 CFR 1610). Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed the device is non-cytotoxic, non-irritating, and non-sensitizing.

Technological Characteristics

Three-layer construction: outer/inner spunbond polypropylene, middle melt-blown polypropylene filter. Nose wire: polypropylene and galvanized steel. Ear loops: spandex. Dimensions: 95mm x 175mm. Non-sterile, single-use. Meets ASTM F2100 Level 3 standards. No software or electronic components.

Indications for Use

Indicated for use by healthcare professionals and patients to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids in infection control practices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Disposable Surgical Mask (K202463)
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On (K202096)

Submission Summary (Full Text)

{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 30, 2022 Sparta East, LLC % Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418 Re: K220378 Trade/Device Name: Sparta 3-Ply Surgical Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 13, 2022 Received: June 17, 2022 Dear Dallas L. Thomas: 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 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. 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) K220378 Device Name Sparta 3-Ply Surgical Disposable Face Mask Indications for Use (Describe) The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### General Information 5.1 5 February 2022 Preparation Date: ## Submitter/Holder / Applicant Ricardo Samayoa General Manager Sparta East LLC 8830 NW 102 Street, Medley, FL 33178 Contact Phone#: 305-924-3610 Email: resamayoa@yahoo.com Primary Submission Contact Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions 5613 Tiger Way Winter Garden, FL 34787 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com #### Regulatory Information 5.2 | Subject Device Name | Sparta 3-Ply Surgical Disposable Face Mask | |-----------------------|--------------------------------------------| | Classification Names | Surgical apparel. | | Device Classification | II | | Common Name | Sparta 3-Ply Surgical Disposable Face Mask | | FDA Product Code | FXX | | CFR References | 21 CFR 878.4040 | | Review Panel | General Hospital | {4}------------------------------------------------ #### 5.3 Identification of Predicate Device The predicate device for this submission has been identified as the Disposable Surgical Mask K202463. #### Subject Device Description 5.4 The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with three layers: Outer Layer: Spunbond polypropylene Middle Layer: Melt Blown polypropylene Inner Layer: Spunbond polypropylene The subject device is provided non-sterile and is a single use, disposable device. A visual representation of the device can be found in the following figure. Image /page/4/Figure/12 description: The image shows a light blue surgical mask. The mask has a white border along the top and bottom edges. The ear loops are white and attached to the sides of the mask. Figure 1: Sparta 3-Ply Surgical Disposable Face Mask Product Image #### ર્સ્ટ Subject Device Specification Design specifications: - Size/Dimensions: ● {5}------------------------------------------------ | Dimensions-Width | 3.74in (9.5 cm) | |-------------------|-----------------| | Dimensions-Length | 6.89in (17.5cm) | - Materials of subject device are as listed below. ● | Outer Layer (Blue) | Spunbond polypropylene | |----------------------|------------------------------------| | Middle Layer (White) | Melt blown polypropylene | | Inner Layer (White) | Spunbond polypropylene | | Nose Wire | Polypropylene and galvanized steel | | Ear Band | Spandex | #### ર્ડ.6 Indications for Use Per the current proposed product labeling, the indications for the Sparta 3-Ply Surgical Disposable Face Mask are quoted as follows: The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device. Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Disposable Surgical Mask K202463 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use. #### 5.7 Substantial Equivalence Discussion Below is a summary table of the Substantial Equivalence between the subject and predicate devices. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that Sparta 3-Ply Surgical Disposable Face Mask is substantially equivalent to the predicate device, Disposable Surgical Mask K202463. {6}------------------------------------------------ K220378 4 of 9 Section 5: 510(k) Summary Sparta 3-Ply Surgical Disposable Face Mask | Device Characteristic | Proposed Subject Device: 3-ply disposable face mask | Primary Predicate Device 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 | Comparison Analysis: | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Surgical Disposable Face Masks | 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On | N/A- Differences do not impact safety or efficacy. | | Manufacturer | Sparta East, LLC | EcoGuard Inc. | N/A- Differences do not impact safety or efficacy. | | FDA Product Code | FXX | FXX | Identical | | CFR Reference | 878.4040 | 878.4040 | Identical | | Device Class | II | II | Identical | | 510(k) reference | TBD | K202096 | N/A- Differences do not impact safety or efficacy. | | Implanted Device | No | No | Identical | | Device Characteristic | Proposed Subject Device: 3-ply disposable face mask | Primary Predicate Device 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 | Comparison Analysis: Identical / Substantially Equivalent / Modified / Cannot Be Determined / Not Applicable | | Indications for use statement | The SPARTA Disposable Surgical Mask is intended to be worn to protect both health care practitioners and patients from transfer of microorganisms, body fluids and particulate material. The masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluids. This is a single use, disposable device, which is provided non-sterile | The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer ofmicroorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile. 3-ply EcoGuard B with Earloop, Model Number: ECOOI 3-ply EcoGuard B with Tie- on, Model Number: ECO02 | Substantially Equivalent, minor wording differences do not impact safety or efficacy. | | Device Generic Raw Materials | Outer Facing Layer: Spunbond nonwoven polypropylene Middle Layer: Melt Blown nonwoven polypropylene filter Inner facing layer: Spunbond nonwoven polypropylene Ear loop: Polyester and Spandex Nose wire: Polypropylene | Outer Facing Layer: Spunbond polypropylene Middle Layer: Melt Blown polypropylene filter Inner facing layer: Spunbond polypropylene Ear loop: Polyester Nylon and Spandex Nose wire: Malleable Polyethylene wire | Substantially Equivalent, minor wording differences do not impact safety or efficacy. | # Table 1. Summary Comparison of Characteristics {7}------------------------------------------------ {8}------------------------------------------------ | | Sparta 3-Ply Surgical Disposable Face Mask | | |--|--------------------------------------------|--| | | | | | Device Characteristic | Proposed Subject Device: 3-ply disposable face mask | Primary Predicate Device 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 | Comparison Analysis: Identical / Substantially Equivalent / Modified / Cannot Be Determined / Not Applicable | |----------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Color (outward facing Layer) | Blue | Blue | Identical | | Color (middle Layer) | White | Not publically available | Modified - Minor differences do not impact safety or efficacy. | | Color (inward facing Layer) | White | Not publically available | Modified - Minor differences do not impact safety or efficacy. | | Colorant(s) -ALL Needed in terms of Material Name / Chemical Name | N/A | Not publically available | Modified - Minor differences do not impact safety or efficacy. | | Patient Anatomical Site for Use of Device | Nose and Mouth | Nose and Mouth | Identical | | Mode of Operation | Protective Mask | Protective Mask | Identical | | Reusable or Single Use | Single Use | Single Use | Identical | | Sold Sterile or Non- Sterile | Non-Sterile | Non-Sterile | Identical | | Prescription Status | OTC | OTC | Identical | | Fluid Resistance Performance ASTM F1862-13 (how many passing) | 96 Passed (3 batches of 32) | Not publically available | Substantially Equivalent | {9}------------------------------------------------ | | | | | | Sparta 3-Ply Surgical Disposable Face Mask | | |--|--|--|--|--|--------------------------------------------|--| |--|--|--|--|--|--------------------------------------------|--| | Device Characteristic | Proposed Subject Device: 3-ply disposable face mask | Primary Predicate Device 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 | Comparison Analysis: Identical / Substantially Equivalent / Modified / Cannot Be Determined / Not Applicable | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Particulate Filtration Efficiency ASTM F2299 % Passing | ≥98% | ≥ 99% | Substantially Equivalent | | Bacterial Filtration Efficiency ASTM F2101 % Passing | 0.999 | ≥ 98% | Substantially Equivalent | | Differential Pressure (Delta P) EN 14683 Results / Conclusion | <6.0 mmH 2 O/cm 2 | < 6.0 mm H2O/cm2 | Modified - Both the predicate and the subject device passed as per the Standard. No additional concerns related to efficacy are presented. | | Flammability 16 CFR 1610 | Class 1 | Class 1 | Identical | | Cytotoxicity | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Identical | | Irritation | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non- irritating. | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non- irritating. | Identical | | Sensitization | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non- sensitizing. | Under the conditions of the study, the proposed device non-polar and polar extracts were determined to be non- sensitizing. | Identical | | Device Characteristic | Proposed Subject Device: 3-ply disposable face mask | Primary Predicate Device 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 | Comparison Analysis: ldentical / Substantially Equivalent / Modified / Cannot Be Determined / Not Applicable | | Dimensions-Width | 3.74 in (95 mm) | 9.5cm±2cm 3.74" ± 0.40" | Substantially Equivalent - Subject device is within range of the predicate device. | | Dimensions-Length | 6.89 in (175 mm) | 17.5cm±2cm 6.89" ± 0.40" | Substantially Equivalent - Subject device is within range of the predicate device. | | ASTM F2100 Level Tested / Passed | Level 3 | Level 3 | Identical | | Non-Clinical Testing | ASTM F1862 ASTM F2299 ASTM F2101 ASTM F2100 EN 14683 16 CFR 1610 | ASTM F1862 ASTM F2299 ASTM F2101 ASTM F2100 MIL-M369454C 16 CFR 1610 | Substantially Equivalent | {10}------------------------------------------------ #### Sterilization and Shelf Life 5.8 Sterilization and Shelf Life are not applicable to the Sparta 3-Ply Surgical Disposable Face Mask subject device. The device is provided non-sterile and there is no claimed shelf life. #### 5.9 Biocompatibility Biocompatibility tests of Sparta 3-Ply Surgical Disposable Face Mask have been performed on representative finished, sterilized devices as outlined in Table 2. The results from the {11}------------------------------------------------ biocompatibility testing demonstrate that Sparta 3-Ply Surgical Disposable Face Mask is safe and effective for its intended use and biocompatible. | Study | File Name | Attachment No. | Test Method / Standard | |---------------|---------------------------------------------------------|----------------|----------------------------------------| | Sensitization | ATT-15-1_KMH003- SE11_Final_Report | 15-1 | ISO 10993-10:2013 ISO 10993-12:2021 | | Cytotoxicity | ATT-15- 2_Cytoxicity_AMERICA N_PRECLINICAL | 15-2 | ISO 10993-5:2009 ISO 10993-12:2021 | | Irritation | ATT-15- 3_Animal_Irritation- American_Preclinical | 15-3 | ISO 10993-10:2013 ISO 10993-12:2021 | Table 2. Biocompatibility Summary & Standards Applied ## 5.10 Performance Testing - Bench Performance bench tests of Sparta 3-Ply Surgical Disposable Face Mask have been performed, see Table 3. The results from the performance bench testing demonstrate that Sparta 3-Ply Surgical Disposable Face Mask has met the functional requirements and is substantially equivalent to the predicate device. | Study | File Name | Attachment No. | Test Method / Standard | |-------------------------------------------|-----------------------------------------------------|----------------|---------------------------| | Bacterial Filtration Efficiency (BFE) | ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete | 18-1 | ASTM F2101-19 | | Differential Pressure (Delta P) | ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete | 18-1 | EN 14683:2019 | | Synthetic Blood Penetration Resistance | ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete | 18-1 | ASTM F1862 | | Latex Particle Challenge | ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete | 18-1 | ASTM F2299 | | Flammability of Clothing Textiles | ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete | 18-1 | 16 CFR Part 1610 | ## 5.11 Conclusion The conclusions drawn from the performance data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device K202463, Disposable Surgical Mask by Unisources Group, LLC.

Sparta 3-Ply Surgical Disposable Face Mask

Device Facts

Indications for Use

Device Story

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Technological Characteristics

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Sparta 3-Ply Surgical Disposable Face Mask

Device Facts

Indications for Use

Device Story

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Indications for Use

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Special Controls

Predicate Devices

Submission Summary (Full Text)

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