(209 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device is a surgical face mask, an infection control barrier, not a tool for diagnosing medical conditions.
No
The device description clearly outlines a physical surgical face mask made of various materials (polypropylene, polyester Spandex, steel core wire) and includes dimensions and physical components like ear loops, tie-on strings, and a nosepiece. The performance studies also focus on physical properties and filtration efficiency, not software validation.
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 device is for protecting operating room personnel and patients from the transfer of microorganisms, body fluid, and particulate material during surgical procedures. This is a physical barrier function.
- Device Description: The description details a surgical face mask made of various materials designed to filter airborne particles and fluids.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, and biocompatibility). These are tests related to the mask's ability to act as a barrier and filter.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
This device is a surgical face mask, which is a type of personal protective equipment (PPE) and a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel during surgical procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed.
- ASTM 2100: Meets requirements for Level 3.
- Fluid Resistance Performance ASTM F1862: Pass - 32 out of 32 passed at 160 mm Hg for three non-consecutive lots.
- Particulate Filtration Efficiency ASTM F2299: Pass - Mean for three non-consecutive lots = 99.88%, 99.89%, and 98.50%.
- Bacterial Filtration Efficiency ASTM F2101: Pass - Mean for three non-consecutive lots = 98.9%, 98.5%, and 98.4%.
- Differential Pressure (Delta P) EN 14683: Pass - Mean for three non-consecutive lots = 2.11, 2.57, and 4.60 mm H2O/cm².
- Flammability 16 CFR 1610: Pass - 3 non-consecutive lots of each mask model.
- Biocompatibility Testing (ISO 10993-5, ISO 10993-10): Non-Cytotoxic, Non-Sensitizing, Non-Irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- ASTM F1862 Fluid Resistance Performance: 32 out of 32 pass at 160 mm Hg for each of three lots
- ASTM F2299 Particulate Filtration Efficiency: Mean for three lots = 99.88%, 99.89%, and 98.50%, respectively
- ASTM F2101 Bacterial Filtration Efficiency: Mean for three lots = 98.9%, 98.5%, and 98.4%
- Differential Pressure (Delta P): Mean for three lots = 2.11, 2.57, and 4.60 mm H2O/cm²
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 8, 2021
MAF Clothing Pvt Ltd Unit-3 Thomas Knott Senior Regulatory Advisor Benjamin L. England and Associates, LLC 810 Landmark Dr. Suite 126 Glen Burnie, Maryland 21061
Re: K211487
Trade/Device Name: MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 11, 2021 Received: November 15, 2021
Dear Thomas Knott:
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 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.
For Clarence W. Murray III, Ph.D. 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) K211487
Device Name
MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521)
Indications for Use (Describe)
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
| 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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510(k) SUMMARY
Date of Summary Prepared: November 30, 2021 510(k) Number: K211487
| Submitted By: | Benjamin L. England And Associates, LLC |
|---|---|
| Address: | 810 Landmark Drive |
| Suite 126 | |
| Glen Burnie, MD 21061 | |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@englandlawgroup.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
| On Behalf of: | MAF CLOTHING PVT LTD UNIT-3 |
| Address | Sy. No59/3, 59/4. Rajathadripura, Near K B Cross |
| Tiptur Taluk, Tumkur District - 572114. | |
| Karnataka, India. | |
| Phone: | +91- 9513696166 |
| Fax: | None |
| E-Mail: | faizal@mafclothing.com / kirit@mafclothing.com |
| Contact: | Mr. Kirit Jagani (Business Head) |
1. Regulatory Information
| Proprietary Name: | MAF Guard (Ear Loop model SM3P-MB25-2511; Tie-on
model SM3P-MB25-2521) |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Surgical Face Mask, Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Panel | General Surgery Devices |
| Regulation: | 21 CFR 878.4040 |
2. Predicate Device
| 510(k) Number: | K173062 |
|---|---|
| Device Name: | Non Woven Face Mask (Models: VQN0185W (earloop) and |
| VQN0185B (ties)) | |
| Recalls: | A search of the recall database revealed no design-related recalls. |
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3. Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
4. Indications for Use
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
5. Summary of Comparison and Technological Characteristics
| CLASSIFICATION INFORMATION | |||
|---|---|---|---|
| 510(k) Number | K211487 | K173062 | N/A |
| Manufacturer | MAF Clothing Pvt. Ltd. | V&Q Manufacturing Corporation | N/A |
| Proprietary | |||
| Name | MAF Guard (Models Ear Loop – | ||
| SM3P-MB25-2511, Tie-on – | |||
| SM3P-MB25-2521. | Non Woven Face Mask (Models: | ||
| VQN0185W (earloop) and | |||
| VQN0185B (ties)) | N/A | ||
| Common | |||
| Name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II | Class II | Same |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for | |||
| Use | MAF Guard is a device | ||
| intended to be worn by | |||
| operating room personnel | |||
| during surgical procedures to | |||
| protect both the surgical patient | |||
| and the operation room | |||
| personnel from transfer of | |||
| microorganisms, body fluid and | |||
| particulate material. These face | |||
| masks are intended for use in | |||
| infection control practices to | |||
| reduce potential exposure to | |||
| blood and body fluids. The face | |||
| mask is single use, disposable | |||
| device, provided non-sterile. | Non Woven Face Mask (Models: | ||
| VQN0185W (ear loop) and | |||
| VQN0185B (ties)) is intended for | |||
| single use by operating room | |||
| personnel and other general | |||
| healthcare workers to protect | |||
| both patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, blood and body | |||
| fluids, and particulate materials. | Similar | ||
| Model | Three ply, flat pleated with ear | ||
| loops and ties | 3 Ply, Flat-Pleated Style with ear | ||
| loops and ties | Same |
Table 1 - General Comparison
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| MATERIALS | |||
|---|---|---|---|
| Outer Layer | Spunbond Polypropylene | Same | |
| Middle Layer | Melt Blown Polypropylene Filter | Same | |
| Inner Layer | Spunbond Polypropylene | Same | |
| Nose Piece | Steel core wire coated with Polyethylene resin | White aluminum strip covered by PP covering | Different |
| Ear Loops | Polyester Spandex | Urethane elastic fiber | Different |
| Tie strips: | Spunbond polypropylene | Spunbond polypropylene | Same |
| Color | Blue outer layer | Blue | Same |
| Width | 95 ± 3 mm | 95 mm | Same |
| Length | 175 ± 5 mm | 175 mm | Same |
| OTC Use? | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use? | Yes | Yes | Same |
| ASTM F2100 | Level 3 | Level 2 | Different |
| ASTM F1862 Fluid Resistance Performance | 32 out of 32 pass at 160 mm Hg for each of three lots | Pass at 120 mm Hg | Different |
| ASTM F2299 Particulate Filtration Efficiency | Mean for three lots = 99.88%, 99.89%, and 98.50%, respectively | Average 99.74% at 0.1µm | Similar |
| ASTM F2101 Bacterial Filtration Efficiency | Mean for three lots = 98.9%, 98.5%, and 98.4% | Average 99.4% | Similar |
| Differential Pressure (Delta P) | Mean for three lots = 2.11, 2.57, and 4.60 mm H2O/cm² | Average 2.7 mm H2O/cm² | Similar |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility Testing | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Same |
Differences in technological characteristics do not raise different questions of safety and effectiveness.
6. Non-clinical Tests Performed on the Proposed Device
The proposed 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.
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Table 2 - Performance Testing
| Test
| Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM 2100 | Meets | ||
| requirements for | |||
| Level 3 | |||
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | To evaluate the resistance to | ||
| penetration by synthetic | |||
| blood, minimum pressure in | |||
| mm Hg | Level 3 requirement: 29 out | ||
| of 32 passed at 160 mm Hg | Pass | ||
| 32 out of 32 | |||
| passed at 160 | |||
| mm Hg | |||
| for three non- | |||
| consecutive lots | |||
| Particulate | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2299 | To evaluate the Sub-micron | ||
| particulate filtration | |||
| efficiency at 0.1 micron (%) | Level 3 requirement: ≥ 98% | Pass | |
| Mean for three | |||
| non-consecutive | |||
| lots = 99.88%, | |||
| 99.89%, and | |||
| 98.50% | |||
| Bacterial | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2101 | To evaluate the BFE of the | ||
| test article using a biological | |||
| aerosol of Staphylococcus | |||
| aureus (%) | Level 3 requirement: ≥ 98% | Pass | |
| Mean for three | |||
| non-consecutive | |||
| lots = 98.9%, | |||
| 98.5%, and | |||
| 98.4% | |||
| Differential | |||
| Pressure (Delta | |||
| P) EN 14683 | To evaluate the Different | ||
| pressure (mm H2O/cm²) | Level 3 requirement: |