← Product Code [FXX](/productcode/FXX) · K221409 # Paneffort 3-ply Surgical and Procedural Masks (K221409) _Paneffort, LLC · FXX · Jul 25, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K221409 ## Device Facts - **Applicant:** Paneffort, LLC - **Product Code:** [FXX](/productcode/FXX.md) - **Decision Date:** Jul 25, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use Paneffort 3-ply Surgical and Procedural masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile. ## Device Story Paneffort 3-Ply Surgical and Procedural masks are flat-pleated, single-use, non-sterile disposable face masks. The device consists of three layers: outer and inner layers of spunbond polypropylene and a middle melt-blown polypropylene filter layer. The mask is secured via earloops (spandex/polyamide) or tie-ons (spunbond polypropylene). A nosepiece made of iron wire, polypropylene, and zinc is encased between the outer and middle layers. The device is used in clinical settings by healthcare personnel and patients to provide a physical barrier against microorganisms, body fluids, and particulates. It is available in Level 2 and Level 3 ASTM F2100 performance ratings. The device functions as a passive barrier; it does not involve active processing or electronic output. Healthcare providers use the mask as personal protective equipment (PPE) to mitigate infection risk during procedures. ## Clinical Evidence Bench testing only. Performance evaluated per ASTM F2100-19e1, including Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683), Sub-micron Particulate Filtration (ASTM F2299), Synthetic Blood Penetration (ASTM F1862), and Flammability (16 CFR Part 1610). Biocompatibility testing conducted per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). All results met acceptance criteria. ## Technological Characteristics Flat-pleated 3-ply mask. Materials: Spunbond polypropylene (inner/outer), melt-blown polypropylene (filter). Nosepiece: Iron wire, polypropylene, zinc. Earloops: Spandex/polyamide. Tie-ons: Spunbond polypropylene. Non-sterile, single-use. Conforms to ASTM F2100-19. No electronic components or software. ## Regulatory 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 - Medical surgical Masks-Non-sterile ([K202594](/device/K202594.md)) - Surgical Face Masks (Ear loops and Tie-on) ([K160269](/device/K160269.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. July 25, 2022 Paneffort, LLC % Vardhini Kirthivas Regulatory Correspondent Freyr Solutions Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli Hyderabad, Telangana 500081 India Re: K221409 Trade/Device Name: Paneffort 3-ply Surgical and Procedural Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 8, 2022 Received: June 10, 2022 Dear Vardhini Kirthivas: 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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. for 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221409 Device Name Paneffort 3-Ply Surgical and Procedural Masks Indications for Use (Describe) Paneffort 3-Ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Traditional 510(k) Paneffort 3-Ply Surgical and Procedural Masks ### K221409 Page 1 of 8 PANEFFORT, LLC ## 510(k) Summary ## Submitter Information: Application Correspondent (US agent): Vardhini Kirthivas | | Freyr Global Regulatory Solutions and Services
Level 4, Building No. H-08, Phoenix SEZ,
Phase 2, Gachibowli, Hyderabad,
Telangana, India, 500081 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone: | +91 - 9940445965 | | E-mail: | usagent@freyrsolutions.com | | Manufacturer: | Paneffort (Cambodia) Garment Co. Ltd.,
National Road No.2, Kleang Sambatt,
Pot Sar Ward, Bati District,
Takeo 21309, Cambodia | | Legal Manufacturer: | PANEFFORT, LLC
700 Elmridge Center Drive
Rochester, NY 14626 | | Phone: | +855 12284810 | | Contact Person: | Harry | E-mail: Fax Number (including area code): Date Prepared: Phil@paneffort.com +855 12284810 11 May 2022 ## Device Identification: | Device Trade Name: | Paneffort 3-ply Surgical and Procedural Masks | |-------------------------------|-----------------------------------------------| | Device Classification name: | Surgical Mask | | Regulation Name: | Surgical Apparel | | Regulation Medical Specialty: | General & Plastic Surgery | | Device Class: | II | | Regulation Number: | 21 CFR 878.4040 | | Product Code: | FXX | {4}------------------------------------------------ ## Predicate Devices: ### Table 1 List of Predicate Devices | Device Name | 510(k) Number | | |--------------------------------------------|---------------|-----------------------------| | Medical surgical Masks-Non-sterile | K202594 | Primary Predicate | | Surgical Face Masks (Ear loops and Tie-on) | K160269 | Additional Predicate Device | ### Device Description The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on. Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later. Paneffort 3-ply Surgical and Procedural masks are available in blue colour. | Sr.
No. | Variants | ASTM
Level | Mask style | Colors | Item Number | |------------|------------------------------|---------------|--------------------|--------|-----------------| | 1. | Paneffort
Procedure Masks | Level 2 | 3-ply Earloop Mask | Blue | (3PML2-EXEL-11) | | 2. | Paneffort
Procedure Masks | Level 3 | 3-ply Earloop Mask | Blue | (3PML3-EXEL-11) | | 3. | Paneffort Surgical
Masks | Level 2 | 3-ply Tie-On Mask | Blue | (3PML2-SRTB-11) | | 4. | Paneffort Surgical
Masks | Level 3 | 3-ply Tie-On Mask | Blue | (3PML3-SRTB-11) | Models: ## Intended Use & Indications for Use Paneffort 3-ply Surgical and Procedural masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile. {5}------------------------------------------------ ## Comparison of Technological Characteristics #### Table 2 Substantial Equivalence Table | S.No | Parameters | | Subject device | Primary Predicate | Additional Predicate Device | Comments | | |------|--------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------| | 1. | Product Name | | Paneffort 3-ply Surgical and
Procedural mask | Medical surgical Masks-Non-
sterile | Surgical Face Masks (Ear
loops and Tie-on) | N/A | | | 2. | 510(k) Number | | To be assigned | K202594 | K160269 | N/A | | | 3. | Manufacturer | | PANEFFORT
(CAMBODIA) GARMENT
CO. LTD. | Shandong T&F Nonwoven Co.
Ltd | SAN - M PACKAGE CO.,
LTD | N/A | | | 4. | Product Code | | FXX | FXX | FXX | Same | | | 5. | Regulation Number | | 878.4040 | 878.4040 | 878.4040 | Same | | | 6. | Intended Use/Indications of Use | | Paneffort 3-ply Surgical and
Procedural Masks are
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These face masks
are intended for use in
infection control practices to
reduce the potential
exposure to blood and body
fluids. This is a single use,
disposable device provided
non-sterile. | The Medical Surgical Masks-
Non-Sterile is intended to be worn
to protect both the patient and
healthcare personnel from the
transfer of microorganisms, body
fluids, and particulate material.
The Medical Surgical Masks -
Non-Sterile is intended for use in
infection control practices to
reduce the potential exposure to
blood and body fluids. This is a
single use, disposable device(s),
provided non-sterile | The Surgical face masks are
intended to be worn to protect
both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
material. These face masks
are intended for use in
infection control practices to
reduce the potential exposure
to blood and body fluids this
is a single use, disposable
device, provided non-sterile. | Same | | | 7. | Material of
Construction | Inner
Layer | Spunbound polypropylene | Polypropylene non-woven fabric | Polypropylene | Same | | | | | Outer
Layer | Spunbound polypropylene | Polypropylene non-woven fabric | Polypropylene | Same | | | | | Middle
Layer | Melt blown polypropylene
filter | Polypropylene meltblown fabric | 1. Polypropylene Spunbound
2. Polypropylene Meltblown | Same | | | S.No | Parameters | Subject device | Primary Predicate | Additional Predicate Device | Comments | | | | | Ear loops | Spandex and polyamide | Polyamide and Polyurethane | Ear loops: Polyester, polyurethane | Different, does not raise any concerns with safety and effectiveness. Note 1 | | | | | Tie-On/Tie strip | Spunbound polypropylene | NA | Tie tapes: Polypropylene Spunbound or polyester Spunbound | Same | | | | | Nose Piece | Iron wire+Polypropylene+Zinc | PP + Iron wire | Polyethylene coated steel wire | Different, does not raise any concerns with safety and effectiveness. Note 2 | | | | 8. | Dimensions | $(9.5 ±3) cm x (17.5 ± 5) cm$ | Length 17.5±5mm
Width 9.5±5mm | Length : 90± 3 mm
Width : 175± 5 mm
Length : 90 ± 3 mm
Width : 180 ± 5 mm | Similar, does not raise any concerns with safety and effectiveness. Note 1 | | | | 9. | Mask Style | Flat pleated | Flat Pleated | Flat - pleated | Same | | | | 10. | Design Features | Ear loop, tie-on | Ear loops | Ear loop and Tie-On | Same | | | | 11. | Sterility | Non- Sterile | Non-sterile | Non- Sterile | Same | | | | 12. | Use | Single Use | Single use | Single Use | Same | | | | 13. | Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Same | | | | 14. | ASTM E2100 Level | Level 2 and Level 3 | Level 2 | Level 2 and Level 3 | Same | | | | S.No | Parameters | Subject device | | Primary Predicate | Additional Predicate Device | Comments | | | | | Level 2 | Level 3 | | | | | | 15. | Bacterial filtration efficiency | Pass at >
99.9 %
(ASTM
F2101) | Pass at >
99.9 %
(ASTM
F2101) | >99%
(ASTM F2101) | Pass at > 98%
(ASTM
F2101) | Similar, Note
3 | | | 16. | Differential pressure (Delta-P) | 3.175
mmH2O/cm²
(EN 14683) | 3.182
mmH2O/cm²
(EN 14683) | < 4.8 mmH2O/cm²
(MIL-M36945C) | Pass at 1.6
mmH2O/cm²
(MIL-
M36945C) | Different,
Note 4 | | | 17. | Sub-micron particulate filtration
efficiency | Pass at ≥
99.20%
(ASTM
F2299) | Pass at ≥
99.20 %
(ASTM
F2299) | >99% | Pass at 99.6%
(ASTM
F2299) | Similar, Note
5 | | | 18. | Resistance to penetration by
synthetic blood, minimum
pressure in mm Hg for pass
result | ≥ 120 mm
Hg (ASTM
F1862) | ≥ 160 mm
Hg
(ASTM
F1862) | Pass at 120mm Hg (ASTM
F1862) | Pass at 120
mm Hg
(ASTM
F1862) | Same | | | 19. | Flammability | Class 1 as per 16 CFR Part
1610 | | Class 1
(16 CFR Part 1610) | Class 1 (16 CFR Part 1610) | Same | | | 20. | Biocompatibility | Cytotoxicity,
ISO 10993-
5:2009 | Pass ISO 10993-5:2009/
under the conditions of
study the subject device was
non-cytotoxic | | Not Cytotoxic | Pass ISO 10993-5:2009/
under the conditions of study
the subject device was non-
cytotoxic. | Same | | | | Irritation,
ISO 10993-
10:2010 | Pass ISO 10993-10:2010/
under the conditions of the
study, the subject device
was non-irritating | | Not an irritant | Pass ISO 10993-10:2010/
under the conditions of the
study, the subject device was
non-irritating. | Same | | | | Sensitization,
ISO 10993-
10:2010 | Pass ISO 10993-10:2010/
under the conditions of
study, the subject device
was non-sensitizing | | Not Sensitive | Pass ISO 10993-10:2010/
under the conditions of study,
the subject device was non-
sensitizing. | Same | {6}------------------------------------------------ # PANEFFORT, LLC # Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks {7}------------------------------------------------ ## PANEFFORT, LLC ## Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks Notel & Note2: The differences in the materials do not any and effectiveness. Performance testing including biocompatibility evaluation mentioned in Section 14 has been performed on the final finished device which includes all construction materials. {8}------------------------------------------------ ### PANEFFORT, LLC Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks Note 3: The performance requirement for BPE as per ASTM F2100 is >9%. The subject device meets the requirements of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria. Note 4: We understand that ML-M-36945C is the FDA recommended standard for differential pressure. However, the conformance to FDA Recognized conservass standard [Rec# 6-425], ASTM F2100-19 requires that Differential pressure be performed as per EN 14683:2019, Annex C. We also understand that as per ASTM F2100-19, passing criteria for and Level 2 mask with respect to differential pressure is <6.0mm HJ0cm² when tested in accordance with EN 14683:2019, Annex C. The subject device meets the criteria. Note 5: The performance requirement for PFE as per ASTM F2100 is ≥98% when tested in accordance with ASTM F2299. The performance of the subject device meets the requirements of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria {9}------------------------------------------------ ## Non-Clinical Testing The following performance tests, in accordance with ASTM F2100 were conducted for the subject device: - . Bacterial filtration efficiency - ASTM F2100-19e1 Clause 9.1 - o ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus. - Differential Pressure ASTM F2100-19e1 Clause 9.2 ● - EN 14683:2019 Medical face masks Requirements and test methods o Annex C - Method for determination of breathability (differential pressure) - Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2100-19e1 ● Clause 9.3 - o ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres - Resistance to Penetration by Synthetic Blood- ASTM F2100-19e1 Clause 9.4 - ASTM F1862 Standard test method for resistance of medical face masks to o penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity) - Flammability - ASTM F2100-19e1 Clause 9.5 - 16 CFR Part 1610 Standard for The Flammability of Clothing Textiles о | S.
No | Test
Method/Standard | Purpose | Acceptance
Criteria | Results | |----------|--------------------------------|-------------------------------------------------|------------------------|---------------------| | 1. | ASTM F2100-
19e1 Clause 9.4 | Resistance to penetration by
synthetic blood | 160mm Hg | Pass at 160mm
Hg | | 2. | ASTM F2100-
19e1 Clause 9.5 | Flammability of Clothing
Textiles | Class I | Class I | | 3. | ASTM F2100-
19e1 Clause 9.2 | Differential Pressure (Delta-P) | ΔP <6mm
H2O/cm² | ΔP <6mm
H2O/cm² | | 4. | ASTM F2100-
19e1 Clause 9.3 | Sub-micron particulate filtration
efficiency | ≥98% | Pass at >99% | | 5. | ASTM F2100-
19e1 Clause 9.1 | Bacterial filtration efficiency | ≥98% | Pass at >98% | Table 3 Table of Non-clinical Testing Standards FDA's guidance, "Surgical Masks - Premarket Notification [510(k)] Submissions ", recommends evaluating the biocompatibility as described in the standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for limited contact devices, contacting intact skin. The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards. - -Cytotoxicity (ISO 10993-5) {10}------------------------------------------------ # Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks - Irritation or Intracutaneous Reactivity (ISO 10993-10) - - -Sensitization (ISO 10993-10) | Biological
endpoint | Test
Method/Standard | Purpose | Acceptance
Criteria | Results | |------------------------------------|-------------------------|---------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Cytotoxicity | ISO 10993-5 | Verify Cytotoxicity
potential of the subject
device | Non-cytotoxic | Pass - ISO 10993-5:2009/ under the
conditions of study
the subject device
was non-cytotoxic. | | Irritation
and
Sensitization | ISO 10993-10 | Verify irritation and
sensitization potential of
the subject device | Non-irritating
and non-
sensitizing | Pass ISO 10993-10:2010/ under the
conditions of the
study, the subject
device was non-
irritating. | ## Table 4 Biocompatibility Testing – Summary # Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/K221409](https://fda-staging.innolitics.com/device/K221409) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com