(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended for infection control by preventing the transfer of microorganisms and body fluids, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions. Its performance metrics relate to filtration and resistance, not diagnostic accuracy.
No
The device description clearly outlines a physical, multi-layered mask made of nonwoven polypropylene with ear loops and a nose piece. The performance studies are bench tests on physical properties, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The Altor Safety 3-Ply Surgical Mask is a physical barrier worn on the face to prevent the transfer of microorganisms, body fluids, and particulate material. It does not analyze any specimens from the body.
- Intended Use: The intended use clearly states it's for protection and infection control by being worn on the face.
- Device Description: The description details the physical construction of the mask.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration, pressure resistance, penetration resistance, flammability), not on analyzing biological samples.
The information provided clearly describes a medical device used for personal protection and infection control, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
Product codes
FXX
Device Description
The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch.
The product model number of the subject device is : 62222
The ASTM Level of the subject device is ASTM Level 2
The subject device is manufactured with three layers:
Outer Layer: Spunbond nonwoven polypropylene
Middle Layer: Melt Blown nonwoven polypropylene
Inner Layer: Spunbond nonwoven polypropylene
The subject device is provided non-sterile and is a single use, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance bench tests of Altor Safety 3-Ply Surgical Mask have been performed, see Table 3. The results from the performance bench testing demonstrate that Altor Safety 3-Ply Surgical Mask has met the acceptance criteria of the standard
Key Metrics
Bacterial Filtration Efficiency (BFE): Lot 1-99.60% BFE, Lot 2-99.80% BFE, Lot 3-99.75% BFE
Differential Pressure (Delta P): 2.6mmH 2 O/cm 2 (2 lots have an average of 2.7)
Synthetic Blood Penetration Resistance: Lot 1:31 out of 32 pass at 120mmHg, Lot 2:32 out of 32 pass at 120mmHg, Lot 3: 32 out of 32 pass at 120mmHg
Latex Particle Challenge: Lot 1 : ≥99%, Lot 2: ≥99%, Lot 3: ≥99%
Flammability: Class I Flammability Rating
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 23, 2021
Altor Safety LLC % Dallas Thomas Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418
Re: K211249
Trade/Device Name: Altor Safety 3-Ply Surgical Mask (Model:62222) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: April 21, 2021 Received: April 26, 2021
Dear Dallas Thomas:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211249
Device Name Altor Safety 3-Ply Surgical Mask (Model:62222)
Indications for Use (Describe)
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
Type of Use (Select one or both, as applicable)
|--|--|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Altor Safety 3-Ply Surgical Mask
510(k) Summary K211249
5.1 General Information
23 July 2021 Preparation Date:
Submitter/Holder
Jared Scott
Altor Safety LLC
711 Executive Boulevard Suite C, Valley Cottage, NY, USA 10989
Contact Phone#: +1 845-422-8320
Contact Email:jared.scott(@altorsafety.com
Primary Submission Contact
Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, FL 33418 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com
Regulatory Information 5.2
| Subject Device Name | Altor Safety 3-Ply Surgical Mask (Model:62222) |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Altor Safety 3-Ply Surgical Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |
4
Altor Safety 3-Ply Surgical Mask
Identification of Predicate Device 5.3
The predicate device for this submission has been identified as the Disposable Surgical Mask K202463.
5.4 Subject Device Description
The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch.
The product model number of the subject device is : 62222
The ASTM Level of the subject device is ASTM Level 2
The subject device is manufactured with three layers:
Outer Layer: Spunbond nonwoven polypropylene
Middle Layer: Melt Blown nonwoven polypropylene
Inner Layer: Spunbond nonwoven polypropylene
The subject device is provided non-sterile and is a single use, disposable device.
A visual representation of the device can be found in the following figure.
Image /page/4/Picture/14 description: The image shows a close-up of a blue surgical mask. The mask has multiple layers and is folded to create a pleated design. The mask also has white ear loops attached to the sides. The bottom of the image has a green and blue background with the text "Actual product may vary from image".
Figure 1: Altor Safety 3-Ply Surgical Mask Product Image
ર.ર Subject Device Specification
Design specifications:
5
Size/Dimensions: ●
| Dimensions-Width | 3.625in (92 mm) |
|---|---|
| Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) |
- . Materials of subject device are as listed below.
| Outer Layer (Blue) | Spunbond nonwoven polypropylene |
|---|---|
| Middle Layer (White) | Melt blown nonwoven polypropylene |
| Inner Layer (White) | Spunbond nonwoven polypropylene |
| Nose Wire | Virgin polyethylene plastic, 24 gauge |
| soft annealed carbon steel, and kraft paper | |
| (nominal basis weight of 25 lbs. /ream) | |
| Ear Band | Spandex |
ર્ડ.૯ Indications for Use
Per the current proposed product labeling, the indications for use for the Altor Safety 3-Ply Surgical Mask (Model:62222) are quoted as follows:
The Altor Safety 3-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, nonsterile, disposable device.
Please note that the above indication is slightly reworded compared to the already cleared indications for the predicate Disposable Surgical Mask K202463 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use.
Technological Characteristics Comparison 5.7
Below is a summary table of the technological characteristics comparison between the subject and predicate devices.
6
| Device Characteristic | Proposed Subject Device | Primary Predicate Device | Comparison Analysis: Identical / Same / Similar / |
|---|---|---|---|
| Product Name | Altor Safety 3 Ply Surgical Mask | Disposable Surgical Mask | Different |
| Manufacturer | Altor Safety | Unisources Group LLC | Different |
| FDA Product Code | FXX | FXX | Identical |
| CFR Reference | 878.4040 | 878.4040 | Identical |
| Device Class | II | II | Identical |
| 510(k) reference | K211249 | K202463 | Different |
| Implanted Device | No | No | Identical |
| Intended Use | The Altor Safety 3-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device. | The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask 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 | Same |
| Device | |||
| Characteristic | Proposed Subject | ||
| Device | Primary Predicate | ||
| Device | Comparison Analysis: | ||
| Identical / Same / | |||
| Similar / | |||
| Indications for | |||
| use statement | The Altor Safety 3-Ply | ||
| Surgical Mask is intended | |||
| to be worn to protect both | |||
| the patient and healthcare | |||
| professional from transfer | |||
| of microorganisms, body | |||
| fluids, and particulate | |||
| material. The Altor | |||
| Safety 3-Ply Surgical | |||
| Mask is intended for use | |||
| in infection control | |||
| practices to reduce the | |||
| potential exposure to | |||
| blood and body fluids. | |||
| This is a single use, non- | |||
| sterile, disposable device. | The Disposable Surgical | ||
| Mask, FILTECH M201 is | |||
| intended to be worn to | |||
| protect both the patient | |||
| and health care personnel | |||
| from transfer of | |||
| microorganisms, body | |||
| fluids and particulate | |||
| material. The disposable | |||
| surgical mask 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. | Same | ||
| Device Generic | |||
| Raw Materials | Outer Facing Layer: | ||
| Spunbond nonwoven | |||
| polypropylene | |||
| Middle Layer: Melt | |||
| Blown nonwoven | |||
| polypropylene filter | |||
| Inner facing layer: | |||
| Spunbond nonwoven | |||
| polypropylene | |||
| Ear loop: Spandex | Outer Facing Layer: | ||
| Spunbond polypropylene | |||
| Middle Layer: Melt | |||
| Blown polypropylene | |||
| filter | |||
| Inner facing layer: | |||
| Spunbond polypropylene | |||
| Ear loop: Spandex | Similar | ||
| ASTM Level | Level 2 | Level 2 | Same |
| Color (outward | |||
| facing Layer) | Blue | Blue | Similar |
| Color (middle | |||
| Layer) | White | Not-publicly Available | Different |
| Color (inward | |||
| facing Layer) | White | Not-publicly Available | Different |
| Device | |||
| Characteristic | Proposed Subject | ||
| Device | Primary Predicate | ||
| Device | Comparison Analysis: | ||
| Identical / Same / | |||
| Similar / | |||
| Colorant(s) | Submitted Independently | ||
| to FDA by supplier as | |||
| this was considered | |||
| proprietary information. | Not-publicly Available | Different | |
| Patient | |||
| Anatomical Site | |||
| for Use of Device | Nose and Mouth | Nose and Mouth | Identical |
| Mode of | |||
| Operation | Protective Mask | Protective Mask | Identical |
| Reusable or | |||
| Single Use | Single Use | Single Use | Identical |
| Sold Sterile or | |||
| Non-Sterile | Non-Sterile | Non-Sterile | Identical |
| Prescription | |||
| Status | OTC | OTC | Identical |
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862-13 | Lot 1:31 out of 32 pass at | ||
| 120mmHg | |||
| Lot 2:32 out of 32 pass at | |||
| 120mmHg | |||
| Lot 3: 32 out of 32 pass at | |||
| 120mmHg | 32 out of 32 pass at | ||
| 120mmHg | Similar | ||
| Particulate | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2299 | Lot 1 : ≥99% | ||
| Lot 2: ≥99% | |||
| Lot 3: ≥99% | ≥98% | Similar | |
| Bacterial | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2101 | Lot 1: 99.60% | ||
| Lot 2: 99.80% | |||
| Lot 3: 99.75% | 99.60% | Similar | |
| Differential | |||
| Pressure (Delta P) | |||
| EN 14683 | 2.6mmH $2$ O/cm $2$ (2 lots have an average of 2.7) | 5.5mmH $2$ O/cm $2$ | Similar |
| Flammability 16 | |||
| CFR 1610 | Class 1 | Class 1 | Identical |
| Cytotoxicity | Under the conditions of | ||
| the study, the proposed | |||
| device extract was | Under the conditions of | ||
| the study, the proposed | |||
| device extract was | Similar | ||
| Device | |||
| Characteristic | Proposed Subject | ||
| Device | Primary Predicate | ||
| Device | Comparison Analysis: | ||
| Identical / Same / | |||
| Similar / | |||
| determined to be non- | |||
| cytotoxic. | determined to be non- | ||
| cytotoxic. | |||
| Irritation | Under the conditions of | ||
| the study, the proposed | |||
| device non-polar and | |||
| polar extracts were | |||
| determined to be non- | |||
| irritating. | Under the conditions of | ||
| the study, the proposed | |||
| device non-polar and | |||
| polar extracts were | |||
| determined to be non- | |||
| irritating. | Similar | ||
| Sensitization | Under the conditions of | ||
| the study, the proposed | |||
| device non-polar and | |||
| polar extracts were | |||
| determined to be non- | |||
| sensitizing. | Under the conditions of | ||
| the study, the proposed | |||
| device non-polar and | |||
| polar extracts were | |||
| determined to be non- | |||
| sensitizing. | Similar | ||
| Dimensions- | |||
| Width | 3.625in (92 mm) | 95mm±5mm | Similar |
| Dimensions- | |||
| Length | 6.75-7.00in (171.45 mm- | ||
| 177.8mm ) | 175mm±5mm | Similar | |
| ASTM F2100 | |||
| Level | Level 2 | Level 2 | Identical |
Table 1.Technological Characteristics Comparison Table
7
8
9
Sterilization and Shelf Life 5.8
Sterilization and Shelf Life are not applicable to the Altor Safety 3-Ply Surgical Mask subject device. The device is provided non-sterile and there is no claimed shelf life.
5.9 Biocompatibility
Biocompatibility tests of Altor Safety 3-Ply Surgical Mask have been performed on
10
representative finished, sterilized devices as outlined in Table 2.
Table 2. Biocompatibility Summary & Standards Applied
| Test Method/
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity | For the test to be valid, the reagent control and | |
| the negative control must have had a reactivity | |||
| of none (grade 0) and the positive control must | |||
| have been a grade 3 or 4. Percent rounding and | |||
| percent cells without intracytoplasmic granules | |||
| are not evaluated in the event of 100% lysis. | |||
| The test article met the requirements of the test | |||
| if the biological response was less than or equal | |||
| to grade 2 (mild). The test would have been | |||
| repeated if the controls did not perform as | |||
| anticipated. | No cytotoxicity or cell | ||
| lysis was noted in any of | |||
| the test wells. No pH | |||
| shift was observed at 48 | |||
| hours. The reagent | |||
| control, negative control | |||
| and the positive control | |||
| performed as anticipated. | |||
| ISO 10993-10:2010 | Sensitization | The responses from the challenge phase were | |
| compared within the test animal group and | |||
| between test and control conditions. In the | |||
| final analysis of data, consideration was given | |||
| to the overall pattern, intensity, duration and | |||
| character of reactions of the test as compared | |||
| to the control conditions. The control | |||
| conditions are (1) the control vehicle on the | |||
| test animals, (2) the test on the control | |||
| animals, and (3) the control vehicle on the | |||
| control animals. Statistical manipulation of | |||
| data was not applicable to this study. Grades | |||
| of 1 or greater observed in the test group | |||
| generally indicated sensitization, provided | |||
| that grades of less than 1 were observed on | |||
| the control animals. If grades of 1 or greater | |||
| were noted on control animals, then the | |||
| reactions of test animals that exceeded the | |||
| most severe control reaction were considered | |||
| to be due to sensitization. | Unless otherwise | ||
| indicated, all animals | |||
| were observed with the | |||
| expected dermal | |||
| reactions | |||
| associated with | |||
| intradermal injection of | |||
| FCA and were clinically | |||
| normal throughout the | |||
| study. | |||
| No evidence of | |||
| sensitization was | |||
| observed. | |||
| ISO 10993-10:2010 | Sensitization | The responses from the challenge phase were | |
| compared within the test animal group and | |||
| between test and control conditions. In the final | |||
| analysis of data, consideration was given to the | |||
| overall pattern, intensity, duration and character of reactions | |||
| of reactions of the test as compared to the | |||
| control conditions. The control conditions are | |||
| (1) the control vehicle on the test animals, (2) | |||
| the test on the control animals, and (3) the | |||
| control vehicle on the control animals. | |||
| Statistical manipulation of data was not | |||
| applicable to this study. Grades of 1 or greater | |||
| observed in the test group generally indicated | |||
| sensitization, provided that grades of less than 1 | |||
| were observed on the control animals. If grades | |||
| of 1 or greater were noted on control animals, | Unless otherwise | ||
| indicated, all animals | |||
| were observed with the | |||
| expected dermal | |||
| reactions | |||
| associated with | |||
| intradermal injection of | |||
| FCA and were clinically | |||
| normal throughout the | |||
| study. | |||
| No evidence of | |||
| sensitization was | |||
| observed. |
11
|--|
| Test Method/
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| the most severe control reaction were | |||
| considered to be due to sensitization. | |||
| ISO 10993-10:2010 | Irritation | The erythema and edema site scores for the test | |
| article and control extracts for each animal at | |||
| each scoring interval were calculated by adding | |||
| the erythema and edema scores together. The | |||
| mean score of each individual animal (test and | |||
| control) was calculated by totaling all of the | |||
| individual site scores for each animal and | |||
| dividing by 15 (3 scoring time points x 5 test or | |||
| control sites). The overall mean for each test | |||
| article extract and control extract was | |||
| calculated by adding the mean score for all | |||
| three animals together and dividing by 3. The | |||
| difference between the overall mean score of | |||
| the test article extract and corresponding | |||
| control extract was calculated by subtracting | |||
| the overall mean score for the control extract | |||
| from the overall mean score for the test article | |||
| extract. If the overall mean score of the test | |||
| article extract was less than the overall mean | |||
| score of the corresponding control extract, 0.0 | |||
| was reported. The requirements of the test were | |||
| met if the difference between the test extract | |||
| overall mean score and corresponding control | |||
| overall mean score was 1.0 or less. | All animals appeared | ||
| normal throughout the | |||
| study. | |||
| All injection sites | |||
| appeared normal | |||
| immediately following | |||
| injection. | |||
| ISO 10993-10:2010 | Irritation | No statistical analysis of the data will be | |
| performed. All erythema grades and edema | |||
| grades (24, 48 and 72 hours) will be calculated | |||
| separately for each test and control for each | |||
| individual animal. The score of a test article or | |||
| control on each individual animal will be | |||
| calculated by dividing each of the totals by 15 | |||
| (3 scoring time points x 5 sites). The overall | |||
| mean will be determined for each test and | |||
| control by adding the scores for the 3 animals | |||
| and dividing by 3. The difference between the | |||
| overall mean score of the test article extracts | |||
| and corresponding control extracts will be | |||
| calculated by subtracting the overall mean score | |||
| for the control from the overall mean score for | |||
| the test article extract. If the overall mean score | |||
| of the test article extracts is less than the overall | |||
| mean score of the corresponding control | |||
| extracts, 0.0 will be recorded for the overall | |||
| mean difference between test and control. If at | |||
| any observation period the average reaction to | |||
| the test article extract is questionably greater | |||
| than the average reaction to the control, the test | |||
| will be repeated using three additional rabbits. | |||
| The requirements of the test are met if the | |||
| difference between the test article extract | All animals appeared | ||
| normal throughout the | |||
| study. | |||
| All injection sites | |||
| appeared normal | |||
| immediately following | |||
| injection. |
12
Altor Safety 3-Ply Surgical Mask
| Test Method/
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| overall mean score and the corresponding | |||
| control overall mean score is 1.0 or less. | |||
| Ischemia or necrosis present at the majority of | |||
| the test sites of all animals for any scoring | |||
| interval will be considered as significant | |||
| regardless of the calculated result. The test | |||
| article may fail if either of these findings are | |||
| observed at the majority of the test sites of all | |||
| animals. If the SC control sites on any animal | |||
| exhibits a score 22, or if the SO control sites | |||
| exhibits a score 23, the rabbit will be replaced | |||
| exhibiting the reaction. The replacement animal | |||
| will be injected with the appropriate test article | |||
| extract and control using fresh preparations. |
5.10 Performance Testing - Bench
Performance bench tests of Altor Safety 3-Ply Surgical Mask have been performed, see Table 3. The results from the performance bench testing demonstrate that Altor Safety 3-Ply Surgical Mask has met the acceptance criteria of the standard
| Test Method /
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Bacterial Filtration | |||
| Efficiency (BFE) ASTM | |||
| F2101-19 | Bacterial Filtration | As per Bacterial Filtration | |
| Efficiency (BFE) ASTM F2101-19 | Lot 1-99.60% BFE | ||
| Lot 2-99.80% BFE | |||
| Lot 3-99.75% BFE | |||
| Differential Pressure (Delta | |||
| P) EN 14683:2019 | Breathability | As per Differential Pressure (Delta P) EN | |
| 14683:2019 | 2.6mmH 2 O/cm 2 (2 | ||
| lots have an average of | |||
| 2.7) | |||
| Synthetic Blood | |||
| Penetration Resistance | |||
| ASTM F1862 ISO 22609 | Fluid Resistance | As Per Synthetic Blood Penetration Resistance | |
| ASTM F1862 ISO 22609 | Lot 1:31 out of 32 pass | ||
| at 120mmHg | |||
| Lot 2:32 out of 32 pass | |||
| at 120mmHg | |||
| Lot 3: 32 | |||
| out of 32 pass at 120mmHg |
Table 3. Performance Testing Summary And Standards Applied
13
| Test Method /
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| pass at | |||
| 120mmHg | |||
| Latex Particle Challenge | |||
| ASTM F2299 | Penetration by Particulates | As Per Latex Particle Challenge ASTM F2299 | Lot 1 : ≥99% |
| Lot 2: ≥99% | |||
| Lot 3: ≥99% | |||
| Flammability of Clothing | |||
| Textiles per 16 CFR Part | |||
| 1610 | Flammability | As Per Flammability of Clothing Textiles per 16 | |
| CFR Part 1610 | Class I Flammability | ||
| Rating |
Altor Safety 3-Ply Surgical Mask
5.11 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Altor Safety 3-Ply Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed device