(140 days)
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.
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.
The Sparta 3-Ply Surgical Disposable Face Mask is intended to protect both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. It's designed for single use, non-sterile, and disposable applications in infection control practices. The device was deemed substantially equivalent to the predicate device, Disposable Surgical Mask K202463.
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Comparison Analysis |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | Not publically available (implicitly met by predicate) | 96 Passed (3 batches of 32) | Substantially Equivalent |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 99% | ≥98% | Substantially Equivalent |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 0.999 (implicitly 99.9%) | Substantially Equivalent |
| Differential Pressure (Delta P) (EN 14683) | < 6.0 mm H2O/cm^2 | <6.0 mmH^2O/cm^2 | 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 (ISO 10993-5, ISO 10993-12) | Non-cytotoxic | Non-cytotoxic | Identical |
| Irritation (ISO 10993-10, ISO 10993-12) | Non-irritating | Non-irritating | Identical |
| Sensitization (ISO 10993-10, ISO 10993-12) | Non-sensitizing | Non-sensitizing | Identical |
| Dimensions - Width | 9.5cm ± 2cm (3.74" ± 0.40") | 3.74in (95 mm) | Substantially Equivalent - Subject device is within range of the predicate device. |
| Dimensions - Length | 17.5cm ± 2cm (6.89" ± 0.40") | 6.89in (175 mm) | Substantially Equivalent - Subject device is within range of the predicate device. |
| ASTM F2100 Level | Level 3 | Level 3 | Identical |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance in terms of country of origin for the performance tests. However, for specific tests, some sample details are provided:
- Fluid Resistance Performance (ASTM F1862-13): "96 Passed (3 batches of 32)". This indicates a total of 96 samples were tested across 3 batches, with each batch having 32 samples.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility (Cytotoxicity, Irritation, Sensitization), the sample sizes are not explicitly stated in the provided text. The tests were performed by "INTERTEK-Complete" as indicated in the file names (ATT-18-1_Test_RESULTS-Performance-INTERTEK-Complete). The provenance of this testing (e.g., country of origin of the lab) is not mentioned.
The studies were non-clinical bench tests and biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is typically not applicable to objective performance testing of surgical masks according to recognized standards (ASTM, EN, ISO). The "ground truth" is established by the test method defined in the standard itself, which provides objective measurements (e.g., percentage filtration, pressure drop). There is no mention of experts establishing ground truth for these types of tests in the provided document.
4. Adjudication method for the test set
Not applicable. As described above, the acceptance is based on objective measurements against predefined standards, not expert adjudication of subjective assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a surgical face mask, not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (surgical face mask), not an algorithm or software.
7. The type of ground truth used
For the performance and biocompatibility tests, the ground truth is based on:
- Standardized test methods: Each test (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series) defines the methodology and criteria for performance assessment.
- Objective measurements: The results are derived from quantitative and qualitative measurements according to these standards (e.g., filtration percentages, pressure values, observation of biological reactions).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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.
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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.
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
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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)
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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 |
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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: ●
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| 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.
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K220378 4 of 9
Section 5: 510(k) Summary
Sparta 3-Ply Surgical Disposable Face Mask
| DeviceCharacteristic | Proposed Subject Device:3-ply disposable facemask | Primary Predicate Device3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-OnK202096 | ComparisonAnalysis: |
|---|---|---|---|
| Product Name | Surgical Disposable FaceMasks | 3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-On | N/A-Differences donot impactsafety orefficacy. |
| Manufacturer | Sparta East, LLC | EcoGuard Inc. | N/A-Differences donot impactsafety orefficacy. |
| 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 donot impactsafety orefficacy. |
| Implanted Device | No | No | Identical |
| DeviceCharacteristic | Proposed Subject Device:3-ply disposable facemask | Primary Predicate Device3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-OnK202096 | ComparisonAnalysis:Identical /SubstantiallyEquivalent /Modified /Cannot BeDetermined /NotApplicable |
| Indications for usestatement | The SPARTA DisposableSurgical Mask is intended tobe worn to protect bothhealth care practitioners andpatientsfrom transfer ofmicroorganisms, body fluidsand particulate material. Themasks are intended for use ininfection control practices toreduce thepotential exposure to bloodand bodily fluids. This is asingle use, disposable device,which is provided non-sterile | The Following EcoGuardSurgical Masks are intendedto be worn to protect boththe patient and healthcarepersonnelfrom the transferofmicroorganisms, bodyfluids, and particulatematerial. These surgicalmasks are intended for use ininfection control practices toreduce the potentialexposure to blood and bodilyfluid. These surgical masksare single use,disposable devices providednon-sterile.3-ply EcoGuard B withEarloop, Model Number:ECOOI3-ply EcoGuard B with Tie-on, Model Number: ECO02 | SubstantiallyEquivalent,minorwordingdifferences donot impactsafety orefficacy. |
| Device Generic RawMaterials | Outer Facing Layer:Spunbond nonwovenpolypropyleneMiddle Layer: Melt Blownnonwoven polypropylenefilterInner facing layer: Spunbondnonwoven polypropyleneEar loop: Polyester andSpandexNose wire: Polypropylene | Outer Facing Layer:Spunbond polypropyleneMiddle Layer: Melt Blownpolypropylene filterInner facing layer: SpunbondpolypropyleneEar loop: Polyester Nylon andSpandexNose wire: MalleablePolyethylene wire | SubstantiallyEquivalent,minorwordingdifferences donot impactsafety orefficacy. |
Table 1. Summary Comparison of Characteristics
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| Sparta 3-Ply Surgical Disposable Face Mask | ||
|---|---|---|
| DeviceCharacteristic | Proposed Subject Device:3-ply disposable facemask | Primary Predicate Device3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-OnK202096 | ComparisonAnalysis:Identical /SubstantiallyEquivalent /Modified /Cannot BeDetermined /NotApplicable |
|---|---|---|---|
| Color (outwardfacing Layer) | Blue | Blue | Identical |
| Color (middle Layer) | White | Not publically available | Modified -Minordifferences donot impactsafety orefficacy. |
| Color (inward facingLayer) | White | Not publically available | Modified -Minordifferences donot impactsafety orefficacy. |
| Colorant(s) -ALLNeeded in terms ofMaterial Name /Chemical Name | N/A | Not publically available | Modified -Minordifferences donot impactsafety orefficacy. |
| Patient AnatomicalSite for Use ofDevice | Nose and Mouth | Nose and Mouth | Identical |
| Mode of Operation | Protective Mask | Protective Mask | Identical |
| Reusable or SingleUse | Single Use | Single Use | Identical |
| Sold Sterile or Non-Sterile | Non-Sterile | Non-Sterile | Identical |
| Prescription Status | OTC | OTC | Identical |
| Fluid ResistancePerformance ASTMF1862-13 (howmany passing) | 96 Passed (3 batches of 32) | Not publically available | SubstantiallyEquivalent |
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| Sparta 3-Ply Surgical Disposable Face Mask | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -------------------------------------------- | -- |
| DeviceCharacteristic | Proposed Subject Device:3-ply disposable facemask | Primary Predicate Device3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-OnK202096 | ComparisonAnalysis:Identical /SubstantiallyEquivalent /Modified /Cannot BeDetermined /NotApplicable |
|---|---|---|---|
| Particulate FiltrationEfficiency ASTMF2299 % Passing | ≥98% | ≥ 99% | SubstantiallyEquivalent |
| Bacterial FiltrationEfficiency ASTMF2101 % Passing | 0.999 | ≥ 98% | SubstantiallyEquivalent |
| Differential Pressure(Delta P) EN 14683Results / Conclusion | <6.0 mmH 2 O/cm 2 | < 6.0 mm H2O/cm2 | Modified -Both thepredicate andthe subjectdevice passedas per theStandard. Noadditionalconcernsrelated toefficacy arepresented. |
| Flammability 16 CFR1610 | Class 1 | Class 1 | Identical |
| Cytotoxicity | Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic. | Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic. | Identical |
| Irritation | Under the conditions of thestudy, the proposed devicenon-polar and polar extractswere determined to be non-irritating. | Under the conditions of thestudy, the proposed devicenon-polar and polar extractswere determined to be non-irritating. | Identical |
| Sensitization | Under the conditions of thestudy, the proposed devicenon-polar and polar extractswere determined to be non-sensitizing. | Under the conditions of thestudy, the proposed devicenon-polar and polar extractswere determined to be non-sensitizing. | Identical |
| DeviceCharacteristic | Proposed Subject Device:3-ply disposable facemask | Primary Predicate Device3-ply EcoGuard B withEarloop, 3-ply EcoGuard Bwith Tie-OnK202096 | ComparisonAnalysis:ldentical /SubstantiallyEquivalent /Modified /Cannot BeDetermined /NotApplicable |
| Dimensions-Width | 3.74 in (95 mm) | 9.5cm±2cm3.74" ± 0.40" | SubstantiallyEquivalent -Subject deviceis within rangeof thepredicatedevice. |
| Dimensions-Length | 6.89 in (175 mm) | 17.5cm±2cm6.89" ± 0.40" | SubstantiallyEquivalent -Subject deviceis within rangeof thepredicatedevice. |
| ASTM F2100 LevelTested / Passed | Level 3 | Level 3 | Identical |
| Non-ClinicalTesting | ASTM F1862ASTM F2299ASTM F2101ASTM F2100EN 1468316 CFR 1610 | ASTM F1862ASTM F2299ASTM F2101ASTM F2100MIL-M369454C16 CFR 1610 | SubstantiallyEquivalent |
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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
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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 10993-10:2013ISO 10993-12:2021 |
| Cytotoxicity | ATT-15-2_Cytoxicity_AMERICAN_PRECLINICAL | 15-2 | ISO 10993-5:2009ISO 10993-12:2021 |
| Irritation | ATT-15-3_Animal_Irritation-American_Preclinical | 15-3 | ISO 10993-10:2013ISO 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 PenetrationResistance | 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 ClothingTextiles | 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.
§ 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.