The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.

The Cufitec Surgical Mask inactivates 99.90% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:

Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions.

Correlations between in vitro testing results and any clinical event has not been tested.

Device Description

The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.

AI/ML Overview

This document describes the premarket notification for the Cufitec Surgical Mask (K182766), a Class II medical device. While it explicitly states that no clinical testing was required or performed (Section 6, Table on Performance Testing, row "Clinical Testing" states "Not applicable. Same – clinical testing is not required to support the subject device."), it details extensive non-clinical performance and antiviral testing to demonstrate substantial equivalence to its predicate device.

Therefore, the requested information regarding "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and the "ground truth used (expert consensus, pathology, outcomes data, etc.)" for AI validation is not applicable to this specific submission, as it concerns a physical surgical mask and not an AI/algorithm-based device.

However, I can extract information related to the acceptance criteria and study proving the physical device meets these criteria, focusing on the non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Performance Bench Testing	Fluid Resistance	Met ASTM F1862 standard (Specific pressure not detailed but implied by standard).	Results met all acceptance criteria per ASTM standards.
	Bacterial Filtration Efficiency (BFE)	Met ASTM F2101 standard (Specific efficiency not detailed but implied by standard).	Results met all acceptance criteria per ASTM standards.
	Particulate Filtration Efficiency (PFE)	Met ASTM F2299 standard (Specific efficiency not detailed but implied by standard).	Results met all acceptance criteria per ASTM standards.
	Delta Pressure	Met MIL-M-36945C standard (Specific pressure differential not detailed but implied by standard).	Results met all acceptance criteria per MIL standards.
	Flammability	Met Class 1, 16 CFR Part 1610.	Results met Class 1, 16 CFR Part 1610.
Antiviral Testing	Antiviral Efficacy (A/H1N1, A/H3N2, B strains)	≥ 99.99% reduction (≥4 log kill) of influenza viruses at 5 minutes' contact for both "fresh" and "aged" test articles.	Achieved 99.99% reduction of the viruses at 5 minutes' contact across all tested strains and conditions (fresh and aged masks, after simulated breathing, and repeated exposure).
	Limit of Quantitation (LOQ) of active ingredient	LOQ of CuI on the mask to be determined (specific numerical criterion for acceptable LOQ not explicitly stated as a pass/fail but as a value determined).	LOQ was determined to be 0.048 µg/cm².
	Neutralization Validation	Neutralizer (SCDLP) must effectively neutralize the antiviral effect of eluted antiviral agent.	Neutralizer effectively neutralized the antiviral effect of eluted antiviral agent.
	Determination of Resistant Strains	Identify the most resistant strains (no specific numerical acceptance criteria, but an outcome of the test).	The three most resistant strains were identified as Influenza A (H3N2): A/Kitakyusyu/159/93, A/HongKong/8/68, and A/Udorn/307/72.
	Simulated Breathing Test (Antiviral Efficacy)	≥ 99.99% reduction of influenza viruses at 5 minutes' contact after simulated breathing, for "fresh" and "aged" articles, against the most resistant strains and selected H1N1 and B strains.	All test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.
	Repeated Exposure Testing (Antiviral Efficacy)	≥ 99.99% reduction of influenza viruses at 5 minutes' contact after repeated exposure, for "fresh" and "aged" articles, against 5 subtypes.	All test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test (likely a typo, should probably refer to repeated exposure instead of simulated breathing test here based on the test name).
	Uniform Distribution Validation	Concentration of active ingredient (CuI) on the surgical mask must be sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples.	The concentration of CuI was sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples.
	Minimum Effective Concentration Testing	The minimum concentration of CuI on the mask must be sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact.	The minimum concentration of CuI on the mask is sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact.
Biocompatibility Testing	Sensitization	Met ISO 10993-10 standard.	Results met ISO 10993-10 standard.
	Irritation	Met ISO 10993-10 standard.	Results met ISO 10993-10 standard.
	Ocular Irritation	Met ISO 10993-10 standard.	Results met ISO 10993-10 standard.
	Chemical Characterization	Met ISO 10993-18 standard; Chemical characterization must support the biological safety of the device (implying no harmful releases or extracts).	The test included analysis of solids released into airflow and extracts by saline and hexane. The results support the biological safety of the device. Results met ISO 10993-18 standard.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of masks or viral samples) used for each non-clinical performance and antiviral test. It mentions "test articles" and "samples" but not the quantity for each specific test.

Data Provenance: The tests are explicitly described as "laboratory (in vitro) tests." The submitter is NBC Meshtec Inc. based in Tokyo, Japan, and the official US correspondent is Globizz Corporation in Gardena, California. It can be inferred that the testing was conducted in a laboratory setting, likely either in Japan or a contracted lab. The data is retrospective in the context of the submission, as the tests were completed and results reported prior to the FDA review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the submission pertains to a physical medical device (surgical mask) and its non-clinical performance characteristics, not an AI/algorithm-based diagnostic device requiring human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable for a physical device's non-clinical performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical or human-reader studies were conducted for this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Standardized laboratory protocols and measurements: Adherence to ASTM, ISO, and MIL standards for physical performance (fluid resistance, filtration, flammability).
Validated laboratory assays: For antiviral efficacy, the "ground truth" is the empirically measured viral reduction (log kill) under controlled in vitro conditions, with specific viral strains and contact times. This is based on established microbiological testing methods.
Chemical and biological characterization: For biocompatibility and active ingredient concentration, the "ground truth" is based on analytical chemistry and toxicology principles, confirmed by tests like ISO 10993 series.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this product would be the iterative design and manufacturing process of the mask itself, involving material selection and coating application, which is not quantified as a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no "training set" in the AI/ML sense. The product's development would have been guided by engineering and materials science principles, aiming to meet the performance criteria established by relevant standards and the intended antiviral claims.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

January 3, 2019

NBC Meshtec Inc. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th St. Suite 200 Gardena, California 90248

Re: K182766

Trade/Device Name: Cufitec Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OUK Dated: December 13, 2018 Received: December 17, 2018

Dear Takahiro Haruyama:

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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K182766

Device Name Cutifec Surgical Mask

Indications for Use (Describe)

Correlations between in vitro testing results and any clinical event has not been tested.

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

1: SUBMITTER INFORMATION

510(k) Owner/Applicant	NBC Meshtec, Inc.2-50-3 Toyoda, Hino-shiTokyo, JAPAN, 191-0053Tel: +81-42-582-1374
NBC Meshtec Correspondent	Tomokazu Nagao, Ph.D.Biology Dept. Manager, R&DNBC Meshtec, Inc.
Official US Correspondent	Takahiro HaruyamaGlobizz Corporation1411 W. 190th St., #200Gardena, CA 90248Tel: (310) 538-3860Email: register@globizz.net
Date Prepared	December 21, 2018

2: DEVICE INFORMATION

Trade Name	Cufitec® Surgical Mask
510(k) Number	K182766
Common Name	Surgical Mask with Antimicrobial/Antiviral Agent
Classification Name	Surgical Apparel
Regulation	21 CFR 878.4040
Review Panel	General Hospital
Product Code	OUK
Device Class	Class II

3: PREDICATE DEVICE

Trade Name	BioFriend™ BioMask™ Surgical FacemaskModels: Universal BF 200-2001A, Premium BF-200-3013A
Manufacturer	Filligent (HK) Limited
Reference	K101128

{4}------------------------------------------------

4: DEVICE DESCRIPTION

5: INDICATIONS FOR USE

Table A. Comparison of indications for use statements.

Cufitec® Surgical MaskSubject Device	BioFriend™ BioMask™ Surgical FacemaskPredicate Device (K101128)
The Cufitec® Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and particulates and has an anti-influenza agent (active ingredient: CuI at 0.5% wt. concentration) on the outer and inner mask layers.	The BioFriend™ BioMask™ surgical facemasks are single-use disposable devices with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2%, a pH lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%, which form ionic bonds with negatively-charged side-groups on influenza viruses).
The Cufitec® Surgical Mask inactivates 99.99% of the following influenza viruses on five minutes' contact with the surface of the facemask in laboratory ( in vitro ) tests against the following influenza viruses:Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62;	The BioFriend™ BioMask™ surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask in laboratory ( in vitro ) tests against the following seasonal, pandemic, avian, swine, and equine influenza viruses: influenza A subtypes and strains: H1N1 (the 2009 pandemic flu subtype A/California/07/09, A Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersey/8/79, A/PR/8/38), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/JAPAN/305/57); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/31); the equine flue subtype; H3N8 (A/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
under tested contact conditions. Correlations between in vitro testing results and any clinical event has not been tested.

{5}------------------------------------------------

6: COMPARISON OF DEVICE CHARACTERISTICS

Manufacturer	NBC Meshtec Inc.	Filligent (HK) Limited	Significant Differences
Trade Name	Cufitec® Surgical Mask(Subject Device)	BioFriend™ BioMask™Surgical FaceMask(Predicate Device)
510(k) No.	K182766	K101128	Same regulatory pathway.
Product Code	OUK	OUK	Same.
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same.
IFU Statement	(See Section 5 above.)	(See Section 5 above.)	Both the subject and predicatedevices are intended to protectfrom the transfer ofmicroorganisms, body fluids,and particulate materials. Bothdevices have an antiviral agentwhich inactivates 99.99% ofinfluenza viruses at 5 minutes'contact with the mask surfaceunder tested contactconditions.The primary differences are theactive ingredients used and thestrains of viruses tested.
Construct	4-ply pleated mask withantiviral agent(L: 8.8 cm x W: 17.5 cm)	4-ply pleated mask withantiviral agent(L: 10 cm x W: 17.5 cm)	Both the subject and predicatedevices follow similarconstructs and are composedof materials commonly used inthe construction of surgicalfacemasks in current legallymarketed devices. The addedantiviral agents in both devicesare indicated to inactivate99.99% of influenza virusstrains at 5 minutes' contactwith the mask surface undertested conditions.The primary differences are theactive ingredients used and thelayers which are coated tocreate the desired effect.
Outer layer material	Rayon fabric with CuIantiviral agent	Spun-bond polypropylenewith hydrophilic plastic
2nd layer material	Polypropylene	Cellulose/polyester withcopper and zinc
3rd layer material	Polypropylene	Melt-blown polypropylene
Inner layer material	Rayon fabric with CuIantiviral agent	Spun-boundpolypropylene
Nosepiece material	Polyethylene	Metal
Ear loops material	Polyurethane and nylon	Elastic, not made withnatural rubber latex
Active Antiviral Agent	Outer and inner layers:0.5% CuI (cuprous iodide)	Outer layer: citric acid 2%2nd layer: copper 1.6%and zinc 1.6%
Sterility	Non-sterile	Non-sterile	Same.
Shelf Life	12 months	12 months	Same.
Trade Name	Cufitec® Surgical Mask(Subject Device)	BioFriend™ BioMask™Surgical FaceMask(Predicate Device)	Significant Differences
Performance Testing
Fluid Resistance	ASTM F1862	ASTM F1862	Same.
Bacterial FiltrationEfficiency	ASTM F2101	ASTM F2101	Same.
ParticulateFiltration Efficiency	ASTM F2299	ASTM F2299	Same.
Delta Pressure	MIL-M-36945C	MIL-M-36945C	Same.
Flammability	Class 1, 16 CFR Part 1610	Class 1, 16 CFR Part 1610	Same.
	B/Lee/40	B/Lee/40	Same.
Tested AntiviralEfficacy(≥4 log kill)	A/WS/33,A/Virginia/ATCC2/2009,A/Kitakyusyu/159/93,A/Udorn/307/72,A/Hong Kong/8/68,A/Victoria/210//09,A/Virginia/ATCC6/2012,B/Taiwan/2/62	A/New Jersey/8/76,A/California/07/09,A/PR/8/34,A/Swine/1976/31,A/Brisbane/59/2007,A/Wisconsin/10/98,A/Brisbane/10/2007,A/Wisconsin/67/2005,A/2/JAPAN/305/57,NIBRG-14,A/Turkey/Wisconsin/1996,A/Duck/PA/10218/84,A/Equine/2/Miami/63,B/Florida/4/2006	There are differences in thenumber and subtypes ofinfluenza strains tested forantiviral efficacy.
Clinical Testing	Not applicable.	Not applicable.	Same – clinical testing is notrequired to support thesubject device.
Biocompatibility Testing
Sensitization	ISO 10993-10	ISO 10993-10	Same.
Irritation	ISO 10993-10	ISO 10993-10	Same.
Ocular Irritation	ISO 10993-10	Not available.	Subject device was tested forocular irritation in accordanceto ISO 10993-10.
ChemicalCharacterization	ISO 10993-18	ISO 10993-18	Same.

Table B. Comparison of technological characteristics to the predicate device.

{6}------------------------------------------------

Table 5C. Comparison of performance and biocompatibility testing.

{7}------------------------------------------------

7: SUMMARY OF NON-CLINICAL TESTING

Performance Bench Testing:

The performance testing includes flammability, fluid resistance, bacterial filtration efficiency (BFE), and particle filtration efficiency (PFE). Results of the performance testing met all acceptance criteria per ASTM and ISO standards.

Antiviral testing:

Chemical characterization was conducted to assess the safety of the device is worn. The test included analysis of solids released into airflow through the mask as well as analysis of extracts by saline and hexane. The results of the study support the biological safety of the device.

Limit of Quantitation (LOO) was designed to determine the limit of active ingredient (CuI) on the mask using uncoated surgical masks. Results demonstrated that the LOQ was 0.048 µg/cm².

Neutralization Validation was performed to validate the neutralization buffer (SCDLP) medium. The results demonstrated that the neutralizer effectively neutralized the antiviral effect of eluted antiviral agent.

Antiviral efficacy was designed to assess both "fresh" and "aged" test articles which were tested against nine subtypes of influenza viruses. The results demonstrate that all test articles met the acceptable criteria of achieving 99.99% reduction of the viruses at 5 minutes' contact.

Determination of resistant strains was performed to determine the strains, out of nine subtypes of influenza. most resistant to both fresh" and aqed" masks. The results show that the three most resistant strains to the device are Influenza A (H3N2): A/Kitakyusyu/159/93, A/HongKong/8/68, and A/Udorn/307/72.

Simulated breathing test was designed to assess the antiviral efficacy of the device after simulated breathing using fresh" and aged" articles aqainst the three most resistant strains of Influenza as well as A/H1N1 (A/Virginia/ATCC2/2009) and Influenza B (B/Lee/40). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.

Repeated exposure testing was conducted to assess both "fresh" and "aged" articles against repeated exposure to Influenza viruses (5 subtypes). The results demonstrate that all test articles met the acceptance criteria of achieving 99.99% reduction of the virus at 5 minutes' contact after simulated breathing test.

Uniform distribution validation was designed to determine the concentration of active ingredient, currous iodide (CuI) on the surqical mask. Results show that the concentration of CuI was sufficiently higher than the minimum effective concentration in both "fresh" and "aged" mask samples.

Minimum effective concentration testing was conducted to determine the minimum effective concentration of CuI on the surgical mask using three different concentrations against the influenza viruses). The minimum concentration of CuI on the mask is sufficiently higher than the minimum effective concentration required for 99.99% reduction of influenza viruses at 5 minutes contact.

7: CONCLUSION

The Cufitec® Surgical Mask and the predicate device are similar in intended use, technological characteristics, and composition of construction materials. Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical performance tests demonstrate that the Cufitec® Surgical Mask is substantially equivalent to the referenced predicate device and is therefore as safe, as effective, and performs as well as or better than the predicate.

Regulation Number and Section

§ 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.