The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses).

The BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator 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/Californial04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional BF-200-3013AN is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.

Device Description

The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The respirator is comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BioFriend™ BioMask™ N95 Surgical Respirator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details performance against recognized standards, specifically ASTM F2100-11 for Medical Face Masks and NIOSH 42 CFR 84 for Respirator Certification. It also includes virucidal efficacy claims.

Description	Test Method	Acceptance Criteria (Predicate/Standard)	Reported Device Performance (N95 Surgical Respirator Professional BF-200-3013AN)
ASTM F2100-11 Medical Face Mask Standards (Level 3)
Bacterial Filtration Efficiency (BFE)	ASTM F2101	> 99% (3M N95); 99.9% (BioMask Predicates)	> 99.9 %
Sub-micron (0.1 µm) Particulate Filtration Efficiency	ASTM F2299	N/A (3M N95); 99.7% (BioMask Predicates)	> 99.9 %
Differential Pressure (Delta-P)	MIL-M-36954C	4.9 mm H2O/cm² (3M N95); 2.6 mm H2O/cm² (BioMask Predicates)	4.9 mm H2O/cm²
Resistance to Penetration by Synthetic Blood	ASTM F1862	160 mm Hg	160 mm Hg
Flame Spread	16 CFR Part 1610	Class 1	Class 1
NIOSH 42 CFR Part 84 - N95 Respirator Standards
Particulate Filtration Efficiency (NaCl)	42 CFR 84.181	Pass (3M N95); N/A (BioMask Predicates)	98 %
Breathing Resistance (Inhalation)	42 CFR 84.180	Pass (3M N95); N/A (BioMask Predicates)	8.0 mm H2O
Breathing Resistance (Exhalation)	42 CFR 84.180	Pass (3M N95); N/A (BioMask Predicates)	8.9 mm H2O
Virucidal Efficacy	In vitro laboratory tests	99.99% viral inactivation at 5 minutes	99.99% (≥4-logs) inactivation of 15 influenza strains

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations," implying standardized and sufficient sample sizes as per GLP.

Data Provenance: The tests were conducted by independent laboratories:
- Nelson Laboratories Inc., Salt Lake City, UT, USA: For bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
- Microbiotest Inc., Sterling, VA, USA: For Virucidal Efficacy testing.
Retrospective or Prospective: These appear to be prospective nonclinical laboratory tests specifically conducted for the device's clearance.

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

This section is Not Applicable as the studies described are non-clinical, laboratory-based performance tests of the device's physical and antimicrobial properties, not assessments requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the standardized test methods themselves.

4. Adjudication Method for the Test Set:

This section is Not Applicable for the same reasons as point 3. There is no human interpretation or adjudication required for these objective performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies presented are laboratory performance tests of the device's material properties and virucidal efficacy, not clinical studies involving human readers or patient cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept typically applies to AI/software as a medical device. Since the device is an N95 surgical respirator, and not an AI algorithm, this section is Not Applicable. The performance described is the standalone performance of the physical device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

Standardized Test Methods and Definitions: The "ground truth" for parameters like BFE, PFE, differential pressure, fluid penetration, and flame spread is defined by the specific ASTM, MIL, 16 CFR, and NIOSH standards and their associated methodologies.
Laboratory-Confirmed Viral Inactivation: For virucidal efficacy, the "ground truth" is the empirically measured reduction in viable virus particles (e.g., cell culture assays) after contact with the mask material under controlled laboratory conditions, as observed and quantified by Microbiotest Inc.

8. The Sample Size for the Training Set:

This section is Not Applicable. The BioFriend™ BioMask™ N95 Surgical Respirator is a physical medical device, not an AI/machine learning model that requires a 'training set.' Its performance characteristics are determined through manufacturing specifications and subsequent testing against established standards.

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

This section is Not Applicable as there is no training set for this type of device.

Summary

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K122702

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MAR 1 8 2013

5. 510(k) Summary

5.1 Applicant and Correspondent

Filligent (HK) Limited Name:

7th Floor, 69 Jervois Street Address: Sheung Wan Hong Kong

Kai Deusch, M.D., Ph.D. Contact Person: Chief Executive Officer

Phone: (852) 2542 2400

Date of Preparation: August 28, 2012

5.2 Manufacturer

Filligent (HK) Limited 7th Floor, 69 Jervois Street Sheung Wan Hong Kong

5.3 Name of Device

Trade/Proprietary/Model Name: BioFriend™ BioMask™ N95 Surgical Respirator

Model: Professional BF-200-3013AN

N95 Respirator, Filtering Facepiece Respirator Common Name: N95 Respirator With Antimicrobial/Antiviral Agent Classification Name: Filtering Facepiece Respirator for Use by Healthcare Workers Classification Regulation: 878.4040 Panel: General Hospital Device Class: Class II Product Code: ONT Recognized Performance Std: ASTM F2100-11, NIOSH 42 CFR 84 (refer to submission)

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Devices to Which New Device is Substantially Equivalent 5.4

Device Name:	BioFriend™ BioMask™ "Premium" BF-200-3013A (Convex)
Manufacturer:	Filligent (HK) Limited
Reference:	K101128
Device Name:	BioFriend™ BioMask™ "Universal" BF-200-2001A (Flat)
Manufacturer:	Filligent (HK) Limited
Reference:	K101128
Device Name:	1870 3M N95 Health Care Particulate Respirator and Surgical Mask
Manufacturer:	3M Company
Reference:	K063023

ર્સ Device Description

5.6 Statement of Intended Use

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A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); 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/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

5.7 Summary of Technological Characteristics

The manufacturing methods and construction materials used in the BioFriend™ BioMask™ N95 surgical respirator Professional BF-200-3013AN, are identical to those used in the following FDAapproved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A (K101128). Filligent (HK) Limited is the manufacturer of these predicate devices and has complete documentation with respect to the manufacturing methods and materials employed. The above BioFriend™ BioMask™ facemasks are identically comprised of four layers of the same material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. The BioFriend™ BioMask™ N95 surgical respirator is also identical in structural shape and design to the following FDA-approved predicate: the BioFriend™ BioMask™ Premium model (BF-200-3013A, convex), except that the meitblown material used in the third layer of the N95 respirator model has

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increased filtration specifications (18g/m² meltblown polypropylene increased to a 50g/m² mettblown polypropylene) to meet the standards required for NIOSH Respirator Certification.

The anti-viral/anti-influenza materials used in the first two active layers of the BioFriend™ BioMask™ N95 surgical respirator are identical in all respects to those of the following FDAapproved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A (K101128). Both the outer and second inner layers are treated with different compounds that independently inactivate viruses through different mechanisms of action. Laboratory (in vitro) tests conducted demonstrate that, as the active layers are identical in all respects and processed by identical manufacturing methods to those in the above predicates, the BioFriend™ BioMask™ N95 surgical respirator inactivates 99.99% (≥4-logs) of 15 different strains of Influenza A and Influenza B viruses, including the circulating 2009 pandemic H1N1, recent vaccine isolates, major reassortments and avian, swine and equine isolates after 5 minutes contact with the mask surface.

The device as a whole is comprised of identical materials and is processed by identical manufacturing methods to the predicates: the BioFriend™ BioMask™ surgical facemasks Universal BF-200-2001A and Premium BF-200-3013A (K101128), and have been previously approved as biocompatible by irritation and sensitization testing, and toxicological assessment of the products ingredients potentially released with inhalation or salivary contact, and indicates that the facemask and respirator products are safe for use in the intended application. Filligent (HK) Limited is the manufacturer of the predicate devices: the BioFriend™ BioMask™ surgical facemasks - Universal BF-200-2001A and Premium BF-200-3013A (K101128), and has complete documentation with respect to the manufacturing methods and materials employed. Therefore the BioFriend™ BioMask™ N95 surgical respirator raises no new safety issues. The device as a whole is substantially equivalent to these predicate devices.

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5.8 Brief description of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

Bacterial Filtration Efficiency ASTM F2101 .
Sub-micron Particulate Filtration Efficiency ASTM F2299 .
Fluid Penetration Resistance ASTM F1862 .
Breathing Resistance MIL-M-3654C .
. Flammability Testing -- 16 CFR 1610
. Biocompatibility - Irritation - ISO 10993-10
Biocompatibility Sensitization ISO 10993-10 .
. Biocompatibility - Chemical Characterization - ISO 10993-18
Breathing Resistance NIOSH 42 CFR 84.180 .
Particulate Filtration Efficiency NIOSH 42 CFR 84.181 .

5.9 Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

Not applicable.

5.10 Conclusions drawn from the nonclinical and clinical tests

The performance testing demonstrates that the BioFriend™ BioMask™ N95 surgical respirator is substantially equivalent to the FDA-approved predicate devices, and that it conforms to the recognized FDA consensus standard ASTM F2100-11 Standard Specification for Performance of Materials used in Medical Face Masks and the NIOSH Respirator Certification - 42 CFR 84 -Approval of Respiratory Protective Devices.

The BioFriend™ BioMask™ N95 surgical respirator has been tested for, and appropriately conforms to the requirements set out in ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and NIOSH Respirator Certification 42 CFR 84 -Approval of Respiratory Protective Devices. Performance testing on the BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN has assessed bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. These tests are defined in the FDA Guidance for Industry and FDA Staff, Surgical Masks - Premarket Notification 510(k) Submissions and in the

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FDA-recognized consensus standard, ASTM F2100-11 Standard Specification for Performance of Materials used in Medical Face Masks and the NIOSH Respirator Certification - 42 CFR 84 -Approval of Respiratory Protective Devices. Tests were conducted at Nelson Laboratories Inc., Salt Lake City, UT. Virucidal Efficacy testing was carried out at Microbiotest Inc., Sterling, VA. All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations.

The construction materials used to provide the mechanical filtration in the BioFriend™ BioMask™ N95 surgical respirator - the polypropylene and meltblown materials - are also identical or similar to all of the following predicate devices: the NIOSH-certified Type N95 3M 1870 N95 Health Care Particulate Respirator and Surgical Mask (K063023), and the BioFriend™ BioMask™ surgical facemasks - Universal BF-200-2001A and Premium BF-200-3013A (K101128) The BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN is substantially equivalent as a whole to the predicate devices and is comprised of identical materials and processed by identical manufacturing methods to the following FDA-approved predicate devices: the BioFriend™ BioMask™ Universal BF-200-2001A, and the BioFriend™ BioMask™ Premium BF-200-3013A. Filligent (HK) Limited is the manufacturer of these predicate devices and has complete documentation with respect to the manufacturing methods and materials employed. Therefore the BioFriend™ BioMask™ N95 surgical respirator raises no new safety issues. The BioFriend™ BioMask™ N95 surgical respirator Professional Model BF-200-3013AN is substantially equivalent as a whole to the above predicate devices.

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Table 5.1: Performance to ASTM F2100 Level 3 Barrier Medical Facemask - Comparison of the BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN to the Predicate Device, the BioFriend™ BioMask™ Surgical
Facemask Model: Premium BF-200-3013A (K101128) and the 1870 3M N95 Health Care Particulate Respirator and Surgical Mask (K063023)

Description	Test Method	BioFriend™BioMask™N95 SurgicalRespiratorProfessionalBF-200-3013AN	BioFriend ™BioMask™ SurgicalFacemasksUniversalBF-200-2001A andPremiumBF-200-3013A	1870 3M N95Health CareParticulateRespirator andSurgical Mask
510(k) Number		K122702	K101128	K063023
Product Code		ONT	OUK	MSH
NIOSH CertificateNumber		TC-84A-6252		TC-84A-3844
Bacterial FiltrationEfficiency	ASTM F2101	> 99.9 %	99.9 %	> 99 %
Sub-micron(0.1 µm) ParticulateFiltration Efficiency	ASTM F2299	> 99.9 %	99.7 %	Information NotDeclared
Differential Pressure(Delta-P)	MIL-M-36954C	4.9 mm H2O/cm²	2.6 mm H2O/cm²	4.9 mm H2O/cm²
Resistance toPenetration bySynthetic Blood	ASTM F1862	160 mm Hg	160 mm Hg	160 mm Hg
Flame Spread	16 CFR Part1610	Class 1	Class 1	Class 1

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Table 5.2: Performance to NIOSH 42 CFR Part 84 - N95 Respirator - Comparison of the BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN to the Predicate Device, the BioFriend™ BioMask™ Surgical Facemask Model: Premium BF-200-3013A (K101128) and the 1870 3M N95 Health Care Particulate Respirator and Surgical Mask (K063023)

Description	Test Method	BioFriend™BioMask™N95 SurgicalRespiratorProfessionalBF-200-3013AN	BioFriend™BioMask™ SurgicalFacemasksUniversalBF-200-2001A andPremiumBF-200-3013A	1870 3M N95Health CareParticulateRespirator andSurgical Mask
510(k) Number		K122702	K101128	K063023
Product Code		ONT	OUK	MSH
NIOSH CertificateNumber		TC-84A-6252		TC-84A-3844
ParticulateFiltration Efficiency(NaCl)	42 CFR 84.181	98 %	N/A	Pass
BreathingResistance	42 CFR 84.180	8.0 mm H2O(Inhalation)8.9 mm H2O(Exhalation)	N/A	Pass.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2013

Kai Deusch, M.D., Ph.D. Chief Executive Officer Filligent (HK) Limited 700 Floor 69 Jervois Street Sheung Wan, Hong Kong

Re: K122702

Trade/Device Name: BioFriend 101 BioMask 114 N95 Surgical Respirator Model: Professional BF-200-3013AN Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: January 14, 2013 Received: February 28, 2013

Dear Dr. Deusch:

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. 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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Page 2 - Dr. Deusch

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure -

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Indications for Use Statement

K122702

510(k) Number (if known):

Device Name:

प

BioFriend™ BioMask™ N95 Surgical Respirator Model: Professional BF-200-3013AN

Indications for Use:

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Prescription Use _ (21 CFR 801 Subpart D) AND/OR

Over-The Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

Elizabeth គ 2013.03.18 4'00'

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

510(k) Number;_ 1122702

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.