(87 days)
Not Found
No
The device description and performance studies focus solely 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, body fluids, and particulate material, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection against transfer of microorganisms and fluids, not for diagnosis of any condition.
No
The device description clearly outlines a physical product (a surgical mask) made of various material layers and components, with performance testing focused on physical properties like filtration efficiency and fluid resistance. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of a surgical mask. There are no components or mechanisms described that would perform a diagnostic test on a sample.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as filtration efficiency, breathability, fluid resistance, and flammability. These are relevant to the mask's function as a barrier, not as a diagnostic tool.
- Key Metrics: The key metrics measured (BFE, Delta-P, PFE, fluid resistance, flame spread) are all related to the physical performance of the mask as a barrier. They are not diagnostic metrics like sensitivity, specificity, PPV, or NPV, which are used to evaluate the performance of diagnostic tests.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Altor Safety 4-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 4-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 4-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 device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. 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 / infection control practices
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
Non-Clinical Performance Testing:
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration: Purpose was to evaluate the Bacterial filtration efficiency (BFE) (%). Pass criteria was >=98%. Results were 3 lots tested with total 96 samples, 94/96 Passed at >=98% /Pass.
- EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019: Purpose was to evaluate the Different pressure (Delta-P). Pass criteria was =98%. Results were 3 lots tested with total 96 samples, 96/96 Passed at >=98% / Pass.
- ASTM F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) according to ASTMF2100:2019 for pass result: Purpose was to evaluate the Resistance to penetration by synthetic blood, Minimum pressure in mmHg. Pass criteria was Fluid resistant claimed at 160 mm Hg. Results were 3 lots tested with total 96 samples, 95 of 96 test articles passed at 160mmHg /Pass.
- 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019: Purpose was to evaluate the Flame spread. Pass criteria was Class 1. Results were 3 lots tested with total 96 samples, 96/96 Passed >=3 seconds burn Time-Class 1 / Pass.
Biocompatibility Testing:
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (=99%
- Flammability (16 CFR 1610): Class 1
- Cytotoxicity: non-cytotoxic
- Irritation: non-irritating
- Sensitization: non-sensitizing
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 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
September 3, 2021
Altor Safety LLC % Dallas Thomas Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418
Re: K211762
Trade/Device Name: Altor Safety 4-Ply Surgical Mask (Model: 62232) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 2, 2021 Received: June 8, 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
1
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 and Part 809 ); medical device reporting (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 Clarence Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211762
Device Name Altor Safety 4-Ply Surgical Mask (Model: 62232)
Indications for Use (Describe)
The Altor Safety 4-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 4-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)
| Research Use Only (314 CFR 201.3(x)) Statement | In-Vitro Sensitivity (314 CFR 201.3(s)) Statement |
|---|---|
| ------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X 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
510(k) Summary
K211762
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.
5.1 General Information
Preparation Date: 2 August 2021
Submitter/Holder
Jared Scott Operations Manager 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 1069 Piccadilly St. Palm Beach Gardens, FL 33418 Mobile +1 801 556 6809 Email: dallas@thomasregulatory.com
5.2 Regulatory Information
Subject Device
| Subject Device Name | Altor Safety 4-Ply Surgical Mask (Model:62232) |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Altor Safety 4-Ply Surgical Mask |
| FDA Product Code | FXX |
4
| CFR References | 21 CFR 878.4040 |
|---|---|
| Review Panel | General Hospital |
Identification of Predicate Device:
| Predicate Device Name | K192374 |
|---|---|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Cardinal Health™ Level 3 Surgical Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |
5.3 Subject Device Description
The Altor Safety 4-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 device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.
Subject Device Specification 5.4
Design specifications:
- Size/Dimensions:
| Mask Dimensions-Width | 3.625in (92 mm) |
|---|---|
| ----------------------- | ----------------- |
5
| Mask Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) |
|---|---|
| Ear Loops Dimensions | Length: .7 inches per each individual ear loop |
- ASTM Level 3
- Product model number: 62232 ●
- Materials of subject device are as listed below. ●
| 2 Outer Facing Layers (Blue) | Spunbond nonwoven polypropylene |
|---|---|
| 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 / Loop | Spandex / Nylon |
ર્સ્ડ Indications for Use
The Altor Safety 4-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 4-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.
6
5.6 Summary of Technological Characteristics
Table 1. Summary Comparison of Characteristics
| Device Characteristic | Proposed Subject
Device | Primary Predicate
Device | Comparison
Analysis: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Product Name | Altor Safety 4-Ply
Surgical Mask | Cardinal Health™
Level 3 Surgical
Mask With Anti-
Fog Foam Strip | Different |
| Manufacturer | Altor Safety | Cardinal Health 200,
LLC | Different |
| FDA Product Code | FXX | FXX | Same |
| CFR Reference | 878.4040 | 878.4040 | Same |
| Device Class | II | II | Same |
| 510(k) reference | K211762 | K192374 | N/A |
| | | | Similar, |
| Indications for use
statement | The Altor Safety 4-
Ply Surgical Mask is
intended to be worn
to protect both the
patient and
healthcare | The Cardinal
Health™ Level 3
surgical masks with
Anti-Fog Foam Strip
are intended to be
worn by operating | Similar, minor
wording differences
do not impact safety
or efficacy. |
| Device Characteristic | Proposed Subject
Device | Primary Predicate
Device | Comparison
Analysis: |
| | professional from
transfer of
microorganisms,
body fluids, and
particulate material.
The Altor Safety 4-
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. | room personnel and
other general
healthcare workers
to protect both
patients and
healthcare workers
against transfer of
microorganisms,
blood and body
fluids, and airborne
particulates. The
Cardinal Health™
Level 3 surgical
masks are single use,
disposable devices
provided non-sterile. | |
| Device Generic Raw
Materials | 2 Outer Facing
Layers: Spunbond
nonwoven
polypropylene
Middle Layer: Melt
Blown nonwoven
polypropylene filter
Inner facing layer:
Spunbond nonwoven
polypropylene
Ear loop: Spandex /
Nylon | Spunbond
Polypropylene
Melt Blown
Polypropylene Filter
Ear loop: Spandex /
Nylon
Nose Wire -plastic, | Similar materials
based on publicly
available details |
| Device Characteristic | Proposed Subject
Device | Primary Predicate
Device | Comparison
Analysis: |
| | Nose Wire - Virgin
polyethylene plastic,
24 gauge
soft annealed carbon
steel, and kraft paper
(nominal basis
weight of 25 lbs.
/ream) | | |
| Color (outward facing
Layer) | Blue | White | Different - |
| Patient Anatomical
Site for Use of Device | Nose and Mouth | Nose and Mouth | Same |
| Mode of Operation | Protective Mask | Protective Mask | Same |
| Reusable or Single
Use | Single Use | Single Use | Same |
| Sold Sterile or Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Prescription Status | OTC | OTC | Same |
| Fluid Resistance
Performance ASTM
F1862-13 | 32 out of 32 pass at
160mmHg | 31 out of 32 pass at
120mmHg | Similar |
| Particulate Filtration
Efficiency ASTM
F2299 | ≥99% | ≥98% | Similar |
7
8
9
| Device Characteristic | Proposed Subject
Device | Primary Predicate
Device | Comparison
Analysis: |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Bacterial Filtration
Efficiency ASTM
F2101 | 99.60% | ≥ 98% | Similar- |
| Differential Pressure
(Delta P) EN 14683 | 3.5mmH 2 0/cm 2
(The average of 3
lots with means of
4.2,3.2 and 3.1)) |