The device is 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.

Device Description

Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Barrier® N95 Particulate Respirators, Models #4272 and #4273, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various standards and NIOSH certifications. The document states that the device "meets the requirements" of these standards and certifications.

Characteristic	Acceptance Criteria (Reference Standard/Certification)	Reported Device Performance
Fluid Resistance	ASTM F1862	Pass
Particulate Filtration Efficiency	NIOSH Certification Number: TC 84A-4350	Meets NIOSH Certification (TC 84A-4350)
Bacterial Filtration Efficiency	NIOSH Certification Number: TC 84A-4350	Meets NIOSH Certification (TC 84A-4350)
Differential Pressure	NIOSH Certification Number: TC 84A-4350	Meets NIOSH Certification (TC 84A-4350)
Flammability	16 CFR 1610 Standard for Flammability of Clothing Textiles	Pass
Cytotoxicity	(Implied: Not cytotoxic, assessed against relevant biological reactivity standards)	Not cytotoxic
Irritation	(Implied: Not irritating, assessed against relevant biological reactivity standards)	Not irritating
Delayed-Type Hypersensitivity	(Implied: No potential for sensitization, assessed against relevant biological reactivity standards)	Does not display any potential for sensitization

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

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting the requirements of established standards and NIOSH certifications. For example, for Fluid Resistance, it states it meets ASTM F1862, which would have its own defined sample sizes for testing. The data provenance is not explicitly mentioned as a specific "country of origin" for testing, but given the applicant is a US LLC and the submission is to the FDA, it is likely that testing adhered to US regulations or internationally recognized standards. The study appears to be retrospective in the sense that it relies on existing standardized tests and certifications rather than a new prospective clinical trial.

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

This information is not provided in the document. The "ground truth" for the performance characteristics is established by the methods, parameters, and pass/fail criteria defined within the referenced standards (e.g., ASTM F1862, NIOSH TC 84A-4350, 16 CFR 1610). These standards are developed by expert committees, but the specific number and qualifications of individuals involved in the testing that led to these results are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this submission. The "adjudication method" usually refers to how discrepancies are resolved when multiple human readers interpret data, often in medical imaging studies. Here, the performance is measured against objective technical standards which typically have clear pass/fail criteria, not subjective interpretations requiring adjudication.

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 document explicitly states: "No clinical data was required." The clearance is based on substantial equivalence to a predicate device, supported by technical performance testing.

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

This is not applicable as the device is a physical N95 respirator, not an algorithm or AI system. The performance evaluated is that of the physical product itself.

7. The Type of Ground Truth Used

The ground truth used is primarily objective technical standards and certifications. These include:

ASTM F1862 (for Fluid Resistance)
NIOSH Certification Number (TC 84A-4350 for filtration efficiency and differential pressure)
16 CFR 1610 Standard for Flammability of Clothing Textiles
Implied biological reactivity testing standards (for cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/13 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side, resembling a molecular structure or a group of cells. To the right of the circles, the text "MÖLNLYCKE" is stacked above "HEALTH CARE" in a simple, sans-serif font. The overall design is clean and professional, conveying a sense of scientific precision and healthcare focus.

-NOV-1-9-2010-

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared:	November 1, 2010
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092
Registration number:	3004763499
Owner/Operator Number:	8030877
Official Correspondent:	Caitlin Senter, MS, RACRegulatory Affairs SpecialistTel: 678-250-7928Fax: 678-245-7746e-mail: caitlin.senter@molnlycke.com
Trade/Proprietary Name:	Barrier® N95 Particulate Respirators, Models #4272 and #4273
Common Name:	Particulate Respirator
Device Class:	Class II
Regulation Number:	21 CFR 878.4040
Product Code:	MSH
Predicate Device Name(s):	Gerson Isolair APR Type N95 Healthcare Particulate Respirator andSurgical Mask Model 2735 (K960778)

Description of Device:

Intended Use/Indication for Use:

The devices 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.

Technological Characteristics:

The Barrier® N95 Particulate Respirators, Models #4273 are substantially equivalent to the ISOLAIR APR Type N95 (K960778). Both devices have similar indications for use, materials, product design, and method of operation.

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

Tel 678 250 7900 Fax 678 250 7984 www.molnlycke.com

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Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles clustered together on the left side of the image. To the right of the circles is the text "MÖLNLYCKE HEALTH CARE" in a simple, sans-serif font. The text is stacked, with "MÖLNLYCKE" on top and "HEALTH CARE" below it.

In the manufacture of these devices, multiple standards were utilized. ... The. Barrier® N95 Particulate Respirators, ... Models #4272 and #4273 characteristics are summarized below as compared to the requirements.

Characteristic

Fluid Resistance

Particulate Filtration Efficiency

Bacterial Filtration Efficiency

Differential Pressure

Flammability

Cytotoxicity

Irritation

Delayed-Type Hypersensitivity

Standard

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 meet the requirements of ASTM F1862.

NIOSH Certification Number: TC 84A-4350 (Models #4272 and #4273)

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 meet the requirements of 16 CFR 1610 Standard for Flammability of Clothing Textiles.

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 are not cytotoxic.

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 are not irritating.

The Barrier® N95 Particulate Respirators. Models #4272 and #4273 do not display any potential for sensitization.

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel 678 250 7900 Fax 678 250 7984 www.molnlycke.com

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Image /page/2/Picture/0 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five black circles on the left, arranged in a triangular shape. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is displayed in a sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

、 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________ ------

---------The table below presents the similarities and differences of the technological characteristics between the Barrier® N95 Particulate Respirators, Models #4272 and #4273 and the predicate device, Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 (K960778).

Feature	Barrier® N95 Particulate Respirators,Models #4272 and #4273(Proposed Device)	Gerson Isolair APR Type N95 Healthcare ParticulateRespirator and Surgical Mask Model 2735(Predicate Device)
510(k) Clearance	TBD	K960778
Manufacturer	Mölnlycke Health Care	LOUIS M. GERSON CO., INC
Common Name	Particulate Respirator	Particulate Respirator
Classification #	Class II	Class II
Classification Name	21 CFR 878.4040	21 CFR 878.4040
Product Code	MSH	MSH
Materials
Outer Material	Polypropylene	Polyester
Inner Material	Polyethylene/Polypropylene	Polyester
Filter Media	Polypropylene	Polypropylene
Nose Clamp	Aluminum	Aluminum/ PVC foam
Binding/cover Tapes	Polyester
Head Bands	Polyurethane (blue), ultrasonically welded	Rubber (green), stapled
Specifications andDimensions	Small MaskLength 205 mm ± 5 mmWidth 85 ± 5 mmBand Length 190 ± 5mm	Medium MaskLength 240 mm ± 5 mmWidth 85 ± 5 mmBand Length 225 ± 5mm
	Length 140 mm ± 6 mmWidth 95 mm ± 6 mmHeight 64 mm ± 3 mmBand Length (top) 318 mm ± 6 mmBand Length (bottom) 260 mm ± 6 mm
Mask Style	Trapezoid mask when folded,Duckbill when open	Cup shaped
Design Features	Single use, flat folded, single use, disposable respiratorLonger vertical bottom length for more conformabilityto wearer,aluminum nose clamp to contour to the wearer
	Single use, cup shaped respiratorContoured nosepieceDouble stapled headstraps
NIOSH certification	TC 84A-4350 (Models #4272 and #4273)	TC 84A-160
Sterililty	Non-sterile	Non-sterile
Fluid Resistance	Pass	Pass
Particulate FiltrationEfficiency	NIOSH Certification Number: TC 84A-4350(Models #4272 and #4273)
	NIOSH Certification Number: TC 84A-160
Bacterial FiltrationEfficiency	NIOSH Certification Number: TC 84A-4350(Models #4272 and #4273)
	NIOSH Certification Number: TC 84A-160
Differential Pressure	NIOSH Certification Number: TC 84A-4350(Models #4272 and #4273)
	NIOSH Certification Number: TC 84A-160
Flammability	Pass	Not Known

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel 678 250 7900 Fax 678 250 7984 www.molnlycke.com

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Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo, there are five black circles clustered together. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in black, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

Performance-Data:- -----------------------------------------------------------------------------------------------------------------------------------------------------------

The performance data are summarized above.

Clinical Testing:

No clinical data was required.

Conclusion:

Based on the performance testing, it can be concluded that the Barrier® N95 Particulate Respirators, Models #4272 and #4273 are equivalent to the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 (K960778) predicate with respect to intended use, materials, design, technological characteristics and performance.

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

.

Tel 678 250 7900 Fax 678 250 7984 www.molnlycke.com

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

Ms. Caitlin Senter Regulatory Affairs Specialist Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

NOV 19 2010

Re: K102923

Trade/Device Name: Barrier® N95 Particulate Respirators, Models #4273, NIOSH Certification TC-84A-4350 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: November 1. 2010 Received: November 2, 2010

Dear Ms. Senter:

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.

ff 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 (reporting of medical device-related 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/CDRH/CDRHOffices/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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side, arranged in a way that they appear to be grouped together. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in bold, uppercase letters.

K102923

	INDICATION FOR USE	NOV 19 2010
--	--------------------	-------------

510(k) Number (if known):	K102923
Device Name:	Barrier® N95 Particulate Respirators, Models #4272 and #4273, NIOSH certification TC-84A-4350
Indication for Use:	The device is 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.

Prescription Use ______	And/Or	Over the Counter Use X
-------------------------	--------	------------------------

(21 CFR Part 801 Subpart D)

And/Or

X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Elaine S. Mayhall

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

102923

510(k) Number:

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel 678 250 7900 Fax 678 250 7984 www.molnlycke.com

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.