AF531 Oro-Nasal SE Face Mask

K243394 · Respironics, Inc. · CBK · Dec 30, 2024 · Anesthesiology

Device Facts

• Record ID: K243394
• Device Name: AF531 Oro-Nasal SE Face Mask
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation. Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

Device Story

Oro-nasal face mask providing patient interface for noninvasive ventilation; covers nose and mouth. Used as accessory to ventilators administering CPAP or positive pressure ventilation. Features click-style elbow for circuit connection; requires separate exhalation device. Used in hospital/institutional environments by clinicians. Provides secure interface for respiratory support; benefits patients with respiratory failure, insufficiency, or obstructive sleep apnea. Available in small, medium, and large sizes with four-point or CapStrap headgear options.

Clinical Evidence

Bench testing only. Verification testing confirmed performance requirements including total mask leak, pressure drop, sound levels, and physical dead space. Biocompatibility evaluated per ISO 10993 and ISO 18562 standards.

Technological Characteristics

Materials: Polycarbonate/polysiloxane faceplate, silicone cushion, polypropylene/polycarbonate elbows, polyurethane foam forehead spacer. Connectivity: 22mm connector. Design: Oro-nasal mask with click-style elbow. Standards: ISO 17510, ISO 10993 series, ISO 18562 series, ISO 5356-1, ISO 14971. Non-sterile.

Indications for Use

Indicated for noninvasive ventilation as an accessory to ventilators for CPAP or positive pressure ventilation in patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea. Medium/Large sizes for patients >30 kg; Small size for patients ≥7 years (>20 kg). For single-patient use in hospital/institutional settings.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• AF541 SE Full Face Mask (K150638)
• AF531 SE Full Face Mask (K101129)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

December 30, 2024

Respironics, Inc. Gary LeMere Principal Regulatory Affairs Specialist 1001 Murry Ridge Ln Murrysville, Pennsylvania 15668

Re: K243394

Trade/Device Name: AF531 Oro-Nasal SE Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: October 31, 2024 Received: October 31, 2024

Dear Gary Lemere:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

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

Sincerely,

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

### Indications for Use

Submission Number (if known)

K243394

Device Name

AF531 Oro-Nasal SE Face Mask

#### Indications for Use (Describe)

Medium and Large Size:

The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.

Small Size:

The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kq) who are appropriate candidates for noninvasive ventilation.

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."

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

## 510(K) Summary – K243394

| Date Prepared | December 27, 2024 |
|------------------------------------------------------|---------------------------------------------------------------------------------------|
| Company Name/ Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[phone] |
| Official Contact | Gary LeMere<br>Principal Regulatory Affairs Specialist |
| Proprietary Name(s) | AF531 Oro-Nasal SE Face Mask |
| Common/Usual Name | Oro-Nasal Face Mask |
| Classification | Class II |
| Product Code | CBK - ventilator, continuous, facility use |
| Regulation Name | Continuous ventilator |
| Regulation Number | 21 CFR 868.5895 |
| Review Panel | Anesthesiology |
| Primary Predicate Device<br>510(k)<br>Product Code | AF541 SE Full Face Mask<br>K150638<br>CBK |
| Secondary Predicate Device<br>510(k)<br>Product Code | AF531 SE Full Face Mask<br>K101129<br>CBK |

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

#### Device Description

The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.

The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.

The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.

#### Indications for Use

#### AF531 Oro-Nasal SE Face Mask

Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.

Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

| Design<br>Parameter or<br>Feature | Subject Device:<br>AF531 Oro-Nasal SE Face<br>Mask | Primary Predicate:<br>AF541 SE Full Face Mask<br>K150638<br>(September 18, 2015) | Secondary Predicate:<br>AF531 SE Full Face Mask<br>K101129<br>(September 16, 2010) | Comments |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | Intended Use | Intended Use | |
| Classification<br>Product Code | CBK | CBK | CBK | Identical |
| Regulation<br>Number | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | Identical |
| Classification | II | II | II | Identical |
| Indications for<br>Use | Medium and Large:<br>The AF531 Oro-Nasal SE<br>Face Mask is intended to<br>provide a patient interface<br>for application of<br>noninvasive ventilation. The<br>mask is to be used as an<br>accessory to ventilators<br>which have adequate alarms<br>and safety systems for<br>ventilation failure, and which | The AF541 SE Full Face<br>Mask is intended to provide<br>a patient interface for<br>application of noninvasive<br>ventilation. The mask is to<br>be used as an accessory to<br>ventilators which have<br>adequate alarms and safety<br>systems for ventilation<br>failure, and which are | The AF531 SE Full Face<br>Mask is intended to<br>provide a patient interface<br>for application of<br>noninvasive ventilation.<br>The mask is to be used as<br>an accessory to ventilators<br>which have adequate<br>alarms and safety systems<br>for ventilation failure, and | Equivalent |
| Design<br>Parameter or<br>Feature | Subject Device:<br>AF531 Oro-Nasal SE Face<br>Mask with click-style elbow | Primary Predicate:<br>AF541 SE Full Face Mask<br>K150638<br>(September 18, 2015) | Secondary Predicate:<br>AF531 SE Full Face Mask<br>K101129<br>(September 16, 2010) | Comments |
| | are intended to administer<br>CPAP or positive pressure<br>ventilation for treatment of<br>respiratory failure,<br>respiratory insufficiency or<br>obstructive sleep apnea.<br>The mask is for single use in<br>the hospital/institutional<br>environment only. The mask<br>is to be used on patients<br>(>30 kg) who are<br>appropriate candidates for<br>noninvasive ventilation.<br><br>Small:<br>The AF531 Oro-Nasal SE<br>Face Mask is intended to<br>provide a patient interface<br>for application of<br>noninvasive ventilation. The<br>mask is to be used as an<br>accessory to ventilators<br>which have adequate alarms<br>and safety systems for<br>ventilation failure, and which<br>are intended to administer<br>CPAP or positive pressure<br>ventilation for treatment of<br>respiratory failure,<br>respiratory insufficiency or<br>obstructive sleep apnea.<br>The mask is for single use in<br>the hospital/institutional<br>environment only. The mask<br>is to be used on patients 7<br>years or older (>20 kg) who<br>are appropriate candidates<br>for noninvasive ventilation. | intended to administer<br>CPAP or positive pressure<br>ventilation for treatment of<br>respiratory failure,<br>respiratory insufficiency or<br>obstructive sleep apnea.<br>The mask is for single use<br>in the hospital/ institutional<br>environment only. The<br>mask is to be used on<br>patients (>40lbs/20kg) who<br>are appropriate candidates<br>for noninvasive<br>ventilation. | which are intended to<br>administer CPAP or<br>positive pressure<br>ventilation for treatment of<br>respiratory failure,<br>respiratory insufficiency, or<br>obstructive sleep apnea.<br>The mask is for single use<br>in the hospital/institutional<br>environment only. The<br>mask is to be used on<br>patients 7 years or older<br>(>40lbs/20kg) who are<br>appropriate candidates for<br>noninvasive<br>ventilation | |
| Patient<br>Population | Small Size: Patients >7<br>years (>20kg)<br>Medium/Large Size: >30kg | All sizes: Patients<br>>40lbs/20kg | Small Size: Patients >7<br>years (>40lbs/20kg) | Equivalent |
| Functional<br>Indication | Interface for application of<br>noninvasive ventilation | Interface for application of<br>noninvasive ventilation | Interface for application of<br>noninvasive ventilation | Identical |
| Environment<br>of Use | Hospital/<br>Institutional Environment | Hospital/<br>Institutional Environment | Hospital/<br>Institutional Environment | Identical |
| Reprocessing<br>Claims | Single use | Single use | Single use | Identical |
| Anatomical<br>Sites | Nose and mouth | Nose and mouth | Nose and mouth | Identical |
| Design<br>Parameter or<br>Feature | Subject Device:<br>AF531 Oro-Nasal SE Face<br>Mask with click-style elbow | Primary Predicate<br>AF541 SE Full Face Mask<br>K150638<br>(September 18, 2015) | Secondary Predicate:<br>AF531 SE Full Face Mask<br>K101129<br>(September 16, 2010) | Comments |
| Sterile State as<br>Provided | Non-Sterile | Non-Sterile | Non-Sterile | Identical |
| Useful Life | ≤ 7 days | Not Defined | Not Defined | Equivalent |
| Device Design | Polycarbonate faceplate<br>Silicone cushion<br>Click-Style Elbows<br>SE option without<br>entrainment valve<br>Elbow retention hub to<br>retain click-style elbow<br>Headgear<br>Accessory Port Cap | Nylon Faceplate<br>Silicone cushion<br>Click-Style Elbows<br>SE option without<br>entrainment valve<br>No elbow retention hub<br>integral to AF541<br>design; elbows attach<br>via faceplate<br>Headgear<br>Accessory Port Cap | Polycarbonate<br>faceplate<br>Silicone cushion<br>Press-fit Elbows<br>SE option without<br>entrainment valve<br>Elbow retention hub to<br>retain press-fit elbow<br>Headgear<br>Pick-off Port Cap | Equivalent |
| Faceplate/<br>Cushion Type | Covers nose and mouth | Covers nose and mouth | Covers nose and mouth | Identical |
| Exhalation<br>Device Design | Separate exhalation device<br>required | Separate exhalation device<br>required | Separate exhalation device<br>required | Identical |
| Headgear Type | CapStrap or four-point<br>headgear | CapStrap or four-point<br>headgear | CapStrap or four-point<br>headgear | Identical |
| Patient Circuit<br>Connection | 22mm click-style elbow with<br>22mm connector | 22mm click-style elbow with<br>22mm connector | 22mm press-fit<br>elbow with 22mm<br>connector | Equivalent |
| Mask Sizes | Small, Medium, and Large | Small, Medium, Large, and<br>Extra-Large | Small | Equivalent |
| Materials -<br>Elbows | SE Click-Style Elbow:<br>Polypropylene (Blue)<br>Accessory Port Cap:<br>Silicone | SE Click-Style Elbow:<br>Polypropylene (Blue)<br>Accessory Port Cap:<br>Silicone | SE Press-Fit Elbow:<br>Polycarbonate (Blue)<br>Pick-off Port Cap:<br>Silicone | Identical to<br>Primary<br>predicate |
| Materials -<br>Mask and<br>Headgear<br>Component | Mask Materials:<br>Faceplate:<br>Polycarbonate/polysiloxane<br>Cushion: Polysiloxane<br>Click-Style Elbow Hub:<br>Polycarbonate<br>Split Washer: Polycarbonate<br>Forehead Arm:<br>Polycarbonate/ polysiloxane<br>Support Retaining Clip:<br>Polycarbonate<br>Forehead Bracket:<br>Polycarbonate/<br>polysiloxane<br>Disposable Foam Forehead<br>Spacer: Polyurethane foam | Mask Materials:<br>Faceplate: Nylon<br>Over the nose / under the<br>nose Cushion: Silicone<br>Over the Nose / under the<br>nose Hub: Nylon<br>Headgear Materials:<br>4 Point Crown Headgear<br>Materials:<br>Forehead Pad Bracket:<br>Nylon<br>Forehead Adjuster Ball<br>Post:<br>Nylon<br>Forehead Adjuster Button:<br>Nylon<br>Disposable Foam Forehead<br>Spacer:<br>Polyurethane | Mask Materials:<br>Faceplate: Polycarbonate/<br>polysiloxane<br>Cushion: Polysiloxane<br>Press-Fit Elbow Hub:<br>Polycarbonate<br>Split Washer:<br>Polycarbonate<br>Forehead Arm:<br>Polycarbonate/<br>polysiloxane<br>Support Retaining Clip:<br>Polycarbonate<br>Forehead Bracket:<br>Polycarbonate/<br>polysiloxane<br>Disposable Foam<br>Forehead Spacer:<br>Polyurethane foam | Equivalent |
| Design<br>Parameter or | Subject Device:<br>AF531 Oro-Nasal SE Face | Primary Predicate<br>AF541 SE Full Face Mask | Secondary Predicate:<br>AF531 SE Full Face Mask | Comments |
| Feature | Mask with click-style elbow | K150638<br>(September 18, 2015) | K101129<br>(September 16, 2010) | |
| | | Headgear Clip:<br>Polypropylene,<br>Tension Clip:<br>Polyoxymethylene<br>Velcro Hook: Nylon<br>Headgear Material: Nylon<br>Polyester Polyurethane,<br>Nylon | | |
| | CapStrap Materials:<br>CapStrap Halo: Nylon<br>CapStrap Soft Goods:<br>Nylon, Polyester/<br>Polyurethane,<br>Polyester/Lycra Knit Elastic<br>CapStrap Clip:<br>Acetal copolymer | CapStrap Headgear:<br>Cap: Nylon Fabric, Foam,<br>Pad Bracket: Nylon<br>Adhesive: Loctite<br>Headgear Clip:<br>Polypropylene<br>Velcro Hook: Nylon | CapStrap Materials:<br>CapStrap Halo: Nylon<br>CapStrap Soft Goods:<br>Nylon,<br>Polyester/ Polyurethane,<br>Polyester/Lycra Knit<br>Elastic<br>CapStrap Clip:<br>Acetal copolymer | |
| | Headgear Materials:<br>Headgear Clip:<br>Acetal copolymer<br>Headgear Material: Nylon,<br>Lycra, Polyester/<br>polyurethane,<br>Polyoxymethylene | Headgear Material: Nylon<br>Polyester Polyurethane | Headgear Materials:<br>Headgear Clip:<br>Acetal copolymer.<br>Headgear Material: Nylon,<br>Lycra Polyester/<br>polyurethane,<br>Polyoxymethylene | |
| Performance Specifications | | | | |
| Pressure<br>Range | 4 to 40cmH2O | 4 to 40cmH2O | 4 to 40cmH2O | Identical |
| Total Mask<br>Leak | Specification:<br>≤15 SLPM@4.0cmH2O<br>≤25 SLPM@40.0cmH2O | SE Specification, all sizes:<br>≤15 SLPM@4.0cmH2O<br>≤25 SLPM@40.0cmH2O | Specification:<br>≤15 SLPM@4.0cmH2O<br>≤25 SLPM@40.0cmH2O | Identical |
| Pressure Drop | Specifications:<br>≤ 1.0cmH2O@50SLPM<br>≤ 4.0cmH2O@100SLPM | Specifications:<br>≤ 1.0cmH2O@50SLPM<br>≤ 4.0cmH2O@100SLPM | Specifications:<br>≤ 1.0cmH2O@50SLPM<br>≤ 4.0cmH2O@100SLPM | Identical |
| Sound Power<br>and Pressure<br>Level | Test results at 10cmH2O:<br>Power Level:18.2dBA@1m<br>Pressure<br>Level:10.9dBA@1m…