POSE™ Health Care Surgical Mask
Device Facts
| Record ID | K223270 |
|---|---|
| Device Name | POSE™ Health Care Surgical Mask |
| Applicant | America'S Supply Chains |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Nov 1, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The POSE™ Health Care Surgical Mask 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 Story
POSE™ Health Care Surgical Mask is a 3-ply, flat-fold, single-use surgical mask; constructed of polypropylene spunbond outer/inner layers and a polypropylene melt-blown filter layer; features spandex ear loops and a polyethylene aluminum nose piece. Device is non-sterile and intended for use by operating room personnel to provide a barrier against microorganisms, body fluids, and particulates. It functions as a passive physical barrier; no electronic or software components. Performance meets ASTM F2100 Level 3 standards for fluid resistance, filtration efficiency, and breathability.
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ASTM F2100 Level 3 requirements: Fluid Resistance (ASTM F1862/ISO 22609, 160mmHg), Particulate Filtration Efficiency (ASTM F2299, ≥98%), Bacterial Filtration Efficiency (ASTM F2101, ≥98%), Differential Pressure (ASTM F2100/EN 14683, <6mmH2O/cm2), and Flammability (16 CFR 1610, Class 1). Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic, non-sensitizing, and non-irritating properties.
Technological Characteristics
3-ply flat-fold mask; materials: polypropylene spunbond (outer/inner), polypropylene melt-blown (filter); polyethylene aluminum nose piece; spandex ear loops. ASTM F2100 Level 3 compliant. Passive device; no energy source, no connectivity, no software. Non-sterile.
Indications for Use
Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Technoweb Surgical Mask (K172500)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2022
America's Supply Chains % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K223270
Trade/Device Name: POSE™ Health Care Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: October 22, 2022 Received: October 24, 2022
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K223270
Device Name POSE™ Health Care Surgical Mask
#### Indications for Use (Describe)
The POSE™ Health Care Surgical Mask 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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| | <span style="text-decoration: overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in large, bold, blue letters, with the apostrophe replaced by a stylized image of a building with columns and a red roof. Below "America's" is the phrase "Supply Chains" in smaller, sans-serif font. The building image is also present in a small circle above the text.
# 510(k) Summary
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92:
### I. SUBMITTER
America's Supply Chains 7555 Warren Pkwy, Unit 486 Frisco, TX 75034 USA
Contact Person:
Paul Park Tel: (617) 800-3602 Email: americasupplychains@gmail.com Date Prepared: October 05, 2022
## II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Regulation Medical Specialty: 510k Review Panel: Product Code:
POSE™ Health Care Surgical Mask Surgical Mask Surgical Apparel Class II (21 CFR §878.4040) General & Plastic Surgery General Hospital FXX
## III. PREDICATE DEVICE
Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): Device Classification Name: Device Name: Regulatory Class: Regulation Number: Classification Product Code: Decision: Regulation Medical Specialty: 510k Review Panel: Type:
YTS GLOBAL INC Technoweb Surgical Mask K172500 mask, surgical Technoweb Surgical Mask Class II (21 CFR §878.4040) 878.4040 FXX Substantially Equivalent (SESE) General & Plastic Surgery General Hospital Traditional
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Image /page/4/Picture/1 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in large, bold letters, with the word "Supply Chains" in smaller letters underneath. Above the text is a small oval containing a stylized image of a building with columns and a roof, suggesting a government or institutional connection. The colors used are primarily blue and red.
## IV. DEVICE DESCRIPTION
POSE™ Health Care Surgical Mask is composed of three-layers and is flat fold. The mask materials consist of an outer cover web (polypropylene spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose.
This device is not made from natural rubber latex.
## V. INDICATIONS FOR USE
POSE™ Health Care Surgical Mask 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.
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
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Image /page/5/Picture/1 description: The image shows the logo for "America's Supply Chains." Above the word "America's" is an oval shape with a building inside. The word "Supply Chains" is written in a smaller font below the word "America's."
| Description | Subject Device<br>POSE™ Health Care<br>Surgical Mask ASTM<br>Level 3 | Predicate Device (K172500)<br>Technoweb Surgical Mask | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use/<br>Indications<br>for Use | is intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect both the surgical<br>patient and the operating<br>room personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material | is intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect both the surgical<br>patient and the operating<br>room personnel from transfer<br>of microorganisms, body<br>fluids, and particulate material | Same |
| Materials | | | |
| Outer Cover<br>Web | Polypropylene Spunbond,<br>white | felt | similar |
| Filter Web<br>(Middle) | Polypropylene Meltblown,<br>white | felt | similar |
| Inner Cover<br>Web | Polypropylene Spunbond,<br>white | felt | similar |
| Nose Piece | Polyethylene Aluminum<br>Wire | Aluminum | similar |
| Ear Loops | Spandex elastic cord | Nylon | similar |
| Style | Flat - Fold | Flat - Fold | Same |
| Multiple<br>Layers | 3-Ply | 3-Ply | Same |
| Colors | White | White | Same |
| Dimension<br>(Width) | 180mm | TM-R is 212mm(W)<br>TM-S is 177.8mm(W) | similar |
| Dimension<br>(Length) | 90mm | TM-R is 74mm(H)<br>TM-S is 138mm(H) | similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | | Similar |
| Use | Single Use | Single Use | Same |
| ASTM F2100<br>Level | Level 3 | | Similar |
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Image /page/6/Picture/1 description: The image shows the logo for "America's Supply Chains". The logo features a building with a red roof and blue columns inside of a circle. The text "America's" is in a large, bold, blue font, and the text "Supply Chains" is in a smaller, bold, blue font below it.
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Image /page/7/Picture/1 description: The image shows the title of a document. The title is "AMERICA'S SUPPLY CHAINS". Below the title is the text "VII. PERFORMANCE DATA". The text is in a larger font size than the title.
The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.
| Item | Proposed Device<br>POSETM Health Care<br>Surgical Mask<br>ASTM Level 3 | ASTM Level 3<br>Mask<br>Standard<br>Acceptance<br>Criteria | Predicate<br>Device<br>(K172500)<br>Technoweb<br>Surgical Mask | Result |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|--------|
| ASTM<br>F1862/ISO<br>22609<br>Fluid<br>Resistance | Three non-sequential lots<br>of 32 (total of 96, AQL<br>4.0) passed at 160mmHg<br>Lot 1: 32 /32 pass<br>Lot 2: 32 /32 pass<br>Lot 3: 32 /32 pass | AQL 4%,<br>single sampling<br>plan, 29 out of<br>32 Pass at<br>160mmHg | | Pass |
| ASTM F2299<br>Particulate<br>Filtration<br>Efficiency | Three non-sequential lots<br>of 32 (total of 96, AQL<br>4.0) passed at ≥98%<br>Lot 1: 32/32 pass<br>Lot 2: 32/32 pass<br>Lot 3: 32/32 pass | ≥ 98% | | Pass |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | Three non-sequential lots<br>of 32 (total of 96, AQL<br>4.0) passed at ≥98%<br>Lot 1: 32/32 pass<br>Lot 2: 32/32 pass<br>Lot 3: 32/32 pass | ≥ 98% | | Pass |
| Differential<br>Pressure<br>ASTM<br>F2100/EN<br>14683:2019 | Three non-sequential lots<br>of 32 (total of 96) passed<br>at <6mmH2O/cm2<br>MIL-M36954C<br>Lot 1: 32/32 pass<br>Lot 2: 32/32 pass<br>Lot 3: 32/32 pass | AQL 4%,<br>single<br>sampling plan,<br><6.0<br>mmH2O/cm2 | | Pass |
## [Table 2: Benchtop Performance Testing]
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Image /page/8/Picture/1 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a bold, stylized font, with the word "SUPPLY CHAINS" in smaller, all-caps letters underneath. Above the text is a circular emblem containing a simplified illustration of a building with a red roof and blue columns, suggesting a governmental or institutional theme.
| Class 1<br>Flammability<br>16 CFR 1610 | Three non-sequential lots<br>of 32 (total of 96, AQL<br>4.0) passed Class 1<br>16 CFR 1610<br>Lot 1: Class 1, DNI<br>Lot 2: Class 1, DNI<br>Lot 3: Class 1, DNI | Class 1<br>< 3.5 second<br>burn time | | Pass |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--|------|
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--|------|
## Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
## Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|------------------------------------|---------------------|--------|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
## [Table 3: Biocompatibility Testing]
## [Table 4: Summary of Non-Clinical Performance Testing]
The following standards have been used to evaluate the High Fluid-Resistant Surgical and Procedure Mask:
| ASTM<br>F2101-19/EN<br>14683:2019 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency<br>(BFE) of Medical Face Mask Materials, Using a Biological Aerosol of<br>Staphylococcus aureus |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM<br>F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to<br>Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume<br>at a Known Velocity) |
| ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency of<br>Materials Used in Medical Face Masks to Penetration by Particulates<br>Using Latex Spheres |
| ASTM F2100/EN | Standard Test Method for Differential Pressure |
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Image /page/9/Picture/1 description: The image shows the logo for "America's Supply Chains." The word "America's" is in a large, bold, dark blue font, with the apostrophe in the shape of a large "S." Below this, the words "Supply Chains" are in a smaller, dark blue font. Above the text is a small oval shape containing a building with columns, also in blue and red.
| 14683:2019<br>ANNEX C | Standard Specification for Performance of Materials Used in Medical<br>Face Masks |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 16 CFR Part 1610<br>EN 14683:2019<br>ANNEX C | Standard for Flammability |
| ISO 10993-5 | ISO 10993-5 Third edition 2009-06-01<br>Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-10 | ISO 10993-10 Third Edition 2010-08-01<br>Biological evaluation of medical devices - Part 10: Tests for irritation<br>and skin sensitization |
## Software Verification and Validation Testing
Not Applicable (Passive Device)
## Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
### Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
### Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
## VIII. CONCLUSIONS
The conclusions drawn from the performance data demonstrate that the subject device is as safe, effective, and performs as well as or better than the legally marketed device K172500, Technoweb Surgical Mask manufactured by YTS GLOBAL INC.
