(152 days)
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 technology.
No
The device description and intended use state that it is a surgical face mask designed to protect from microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed for therapeutic purposes or to treat a disease.
No
Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms and body fluids. It does not diagnose any condition or disease.
No
The device description clearly outlines a physical product (face mask) with material components (four-layer folded masks, ear loops, nose piece). The performance studies focus on physical properties and filtration efficiency, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use clearly state that this is a surgical face mask worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- No mention of testing biological samples: There is no indication that this device is used to analyze or test any biological samples from a patient.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, pressure resistance, flame spread, etc.), not on the accuracy of a diagnostic test.
Therefore, based on the provided information, the 039 Medical Surgical Face Mask is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 039 Medical Surgical Face Mask is 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(s), provided non-sterile.
Product codes
FXX
Device Description
The 039 Medical Surgical Face Mask is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in blue. The 039 Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
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
healthcare personnel
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)
Performance testing was performed following ASTM F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Masks with reference to Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510k] Submission (2004). Three separate non-consecutive lots of 32 samples each were tested.
- Section 6.1 Bacterial Filtration Efficiency ASTM F2101: Measure bacterial filtration efficiency. Acceptance Criteria for Level 2 Barrier: >98% (87 of 96 pass). Results: 99.9% (96 of 96 passed).
- Section 6.1 Differential Pressure (mm H2O/cm2) EN14683:2019+AC:2019 Annex C: Determine breathability of a mask. Acceptance Criteria for Level 2 Barrier: 99% (96 of 96 passed).
- Section 6.1 Resistance to Penetration by Synthetic Blood ASTM F1862/F 1862M-2017: Evaluate the resistance to penetration by impact of small volume of synthetic blood. Acceptance Criteria for Level 2 Barrier: 120 mmHg (Visual inspection, 87 of 96 pass). Results: None seen in 91 of 96 samples.
- Section 6.2 Flame spread 16CFR Part 1610-2008: Response of materials to heat and flame. Acceptance Criteria for Level 2 Barrier: Class 1 (87 of 96). Results: 96 of 96 passed.
Bench testing was performed for Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. The results were similar.
Biocompatibility testing for Cytotoxicity, Sensitization, and Irritation was performed. The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency: 99.9%
- Differential Pressure: Average 99%
- Resistance to Penetration by Synthetic Blood: None seen in 91 of 96 samples at 120 mmHg
- Flame spread: Class 1
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.
November 23, 2021
AOK Tooling Limited % Paul Dryden Consultant AOK Tooling Limited % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K211956
Trade/Device Name: 039 Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 19, 2021 Received: October 22, 2021
Dear Paul Dryden:
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); 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, 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)
K211956
Device Name
039 Medical Surgical Face Mask
Indications for Use (Describe)
The 039 Medical Surgical Face Mask is 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(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
XX_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Page 1 of 5
Date Prepared:
21-Nov-2021
AOK Tooling Limited # 101 And 1Building, 2Building, 3Building, 4Building, 5Building NO. 8 Of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District Shen Zhen, China 518122 Tel - +852-0-23101703
| Sponsor Contact: | Francis Nithyananthan
Project Director |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Paul Dryden
ProMedic Consulting LLC |
| Proprietary or Trade Name: | 039 Medical Surgical Face Mask |
| Common/Usual Name: | Mask, Surgical |
| Classification Name: | Product Code - FXX – Mask, Surgical |
| Predicate Devices: | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. -
K202605 |
| Device Description: | The 039 Medical Surgical Face Mask is single use, four-
layer folded masks with ear loops, or straps to tie behind
the user's head, and a nose piece. The ear loops are held
in place over the users' mouth and nose by two elastic
ear loops welded to the facemask. The elastic ear loops
are not made with natural rubber latex. The nose piece in
the layers of facemask is to allow the user to fit the
facemask around their nose, which is made of malleable
polyethylene wire. The surgical face masks will be
provided in blue. The 039 Surgical Face Mask is sold
non-sterile and are intended to be single use, disposable
devices. |
| Principle of Operation: | A surgical mask covers the user's nose and mouth and
provides a physical barrier to fluids and particulate
materials. |
| Indications for Use: | The 039 Medical Surgical Face Mask 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(s), provided non-sterile. |
4
510(k) Summary Page 2 of 5
| Description | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. | AOK Tooling Ltd. | |
| 510(k) Number | K202605 | K211956 | |
| Model Name | Standard Procedure Mask, Standard Surgical Mask | 039 Medical Surgical Face Mask | |
| Classification | Class II Device | ||
| FXX | |||
| 21 CFR878.4040 | Class II Device | ||
| FXX | |||
| 21 CFR878.4040 | Identical | ||
| Intended use / | |||
| Indications for Use | The device is 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 039 Medical Surgical Face Mask 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(s), provided non-sterile. | Identical | ||
| Mask Style | Flat pleated | Folded | The mask style is |
| different, but | |||
| performance is similar to | |||
| the predicate* | |||
| Materials | |||
| Cover Fabric(s) | Spunbonded nonwoven and Melt blown nonwoven | ||
| fabric | Non-woven polypropylene; Melt blown non- | ||
| woven polypropylene filter | The difference does not | ||
| impact device | |||
| performance* | |||
| Nose Piece | Plastic | Silicone | The difference does not |
| impact device | |||
| performance* | |||
| Ear Loops / Tie-on | Polyester and spandex and | ||
| Spunbonded nonwoven | Spandex | Identical | |
| Color | Blue | Blue and White | Similar |
| Design | Ear loop and tie-on | Ear loop and tie-on | Identical |
| Dimension (Width / | |||
| Length) Flat even though | |||
| subject device is folded | 175×95 mm | Small - 208x111 mm | |
| Medium - 226x124 mm | |||
| Large - 250x138 mm | |||
| Xlarge - 262x144 mm | The size difference does | ||
| not impact device | |||
| performance* | |||
| OTC Use | Yes | Yes | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| ASTM 2100 Level | Level 2 | Level 2 | Identical |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Identical |
| Particulate efficiency level | ≥98% | ≥98% | Identical |
| Bacterial filtration level | ≥98% | ≥98% | Identical |
| Differential pressure | 98% | ||
| 87 of 96 pass | 99.9% | ||
| 96 of 96 passed | |||
| Section 6.1 Differential | |||
| Pressure (mm $H_2O/cm^2$ ) | |||
| EN14683:2019+AC:2019 | |||
| Annex C | Determine | ||
| breathability of a mask | 99% | ||
| 96 of 96 passed | |||
| Section 6.1 Resistance to | |||
| Penetration by Synthetic | |||
| Blood ASTM F1862/F | |||
| 1862M-2017 | Evaluate the resistance | ||
| to penetration by | |||
| impact of small volume | |||
| of synthetic blood | 120 mmHg | ||
| Visual inspection | |||
| 87 of 96 pass | None seen in | ||
| 91 of 96 samples | |||
| Section 6.2 Flame spread | |||
| 16CFR Part 1610-2008 | Response of materials | ||
| to heat and flame | Class 1 | ||
| 87 of 96 | 96 of 96 passed |
7
510(k) Summary Page 5 of 5
Bench testing -
We performed the following tests: Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. Discussion - The results were similar.
Biocompatibility -
Both devices are considered Surface Contact, Intact Skin, Limited Duration of Use. Discussion - The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the 039 Medical Surgical Face Mask device is as safe, as effective, and performs as well as or better than the legally marketed device in K202605.