AOK 95A Medical Mask (20200049)
Device Facts
| Record ID | K220876 |
|---|---|
| Device Name | AOK 95A Medical Mask (20200049) |
| Applicant | Aok Tooling Limited |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jul 27, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The AOK 95A Medical Mask (20200049) 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.
Device Story
AOK 95A Medical Mask is a single-use, non-sterile, four-layer flat-pleated surgical mask; features ear loops or tie-on straps and a malleable polyethylene wire nose piece for fit. Constructed from non-woven polypropylene, melt-blown polypropylene filter, PET non-woven fabric, and spandex ear loops. Used in clinical settings by healthcare personnel and patients as a physical barrier to reduce exposure to blood, body fluids, and particulates. Operates by covering the nose and mouth to provide filtration and fluid resistance. Performance meets ASTM 2100 Level 2 standards. Intended for infection control; provides protection for both wearer and patient.
Clinical Evidence
Bench testing only. Performance testing included fluid resistance (120 mmHg), flammability (Class I), particulate filtration efficiency (≥98%), bacterial filtration efficiency (≥98%), and differential pressure (<6.0 mm H2O/cm2). Biocompatibility testing (cytotoxicity, sensitization, irritation) confirmed safety for surface contact with intact skin.
Technological Characteristics
Four-layer construction: 50g non-woven outer, 20g melt-blown polypropylene filter, 70g PET non-woven, 30g non-woven inner. Features: malleable polyethylene wire nose piece, spandex ear loops. Dimensions: Small (165x70mm), Medium (190x80mm), Large (210x86mm). ASTM 2100 Level 2 compliant. Non-sterile, single-use, disposable.
Indications for Use
Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- AOK Tooling Limited - 039 Surgical Face Mask (K211956)
Submission Summary (Full Text)
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July 27, 2022
AOK Tooling Limited Paul Dryden Consultant AOK Tooling Limited c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K220876
Trade/Device Name: AOK 95A Medical Mask (20200049) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2022 Received: July 22, 2022
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number (if known)
K220876
Device Name
# AOK 95A Medical Mask (20200049)
Indications for Use (Describe)
The AOK 95A Medical Mask (20200049) 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
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# Date Prepared:
20-Jul-2022
AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485 Castle Peak Road, Cheung Sha Wan, Kowloon Hong Kong, China
| Official Contact: | Jerry Teng<br>1-626-203-3809 |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name:<br>Common/Usual Name:<br>Classification Name: | AOK 95A Medical Mask (20200049)<br>Mask, Surgical<br>Product Code - FXX - Mask, Surgical |
| Predicate Device:<br>Common/Usual Name:<br>Classification Name: | AOK Tooling Limited - K211956<br>Mask, Surgical<br>Product Code - FXX - Mask, Surgical |
| Device Description: | The AOK 95A Medical Mask (20200049) is single use,<br>four-layer folded masks with ear loops, or straps to tie<br>behind the user's head, and a nose piece. The ear loops<br>are held in place over the users' mouth and nose by two<br>elastic ear loops welded to the facemask. The elastic ear<br>loops are not made with natural rubber latex. The nose<br>piece in the layers of facemask is to allow the user to fit<br>the facemask around their nose, which is made of<br>malleable polyethylene wire. The AOK 95A Medical<br>Mask will be provided in white and blue. The AOK 95A<br>Medical Mask is sold non-sterile and are intended to be<br>single use, disposable devices. |
| Principle of Operation: | The mask covers the user's nose and mouth and provides<br>a physical barrier to fluids and particulate materials. |
| Indications for Use: | The AOK 95A Medical Mask (20200049) is intended to<br>be worn to protect both the patient and healthcare<br>personnel from transfer of microorganisms, body fluids<br>and particulate material. These face masks are intended<br>for use in infection control practices to reduce the<br>potential exposure to blood and body fluids. This is a<br>single use, disposable device(s), provided non-sterile. |
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| Description | Subject Device | Predicate Device | Differences |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Manufacturer | AOK Tooling Ltd. | AOK Tooling Ltd. | |
| 510(k) Number | TBD | K211956 | |
| Model Name | AOK 95A Medical Mask (20200049) | 039 Surgical Face Mask | |
| Classification | Class II Device<br>FXX<br>21 CFR 878.4040 | Class II Device<br>FXX<br>21 CFR 878.4040 | Identical |
| Intended use | The AOK 95A Medical Mask (20200049) is intended<br>to be worn to protect both the patient and healthcare<br>personnel from transfer of microorganisms, body fluids<br>and particulate material. These face masks are intended<br>for use in infection control practices to reduce the<br>potential exposure to blood and body fluids. This is a<br>single use, disposable device(s), provided non-sterile. | The 039 Surgical Face is intended to be worn to<br>protect both the patient and healthcare personnel<br>from transfer of microorganisms, body fluids and<br>particulate material. These face masks are intended<br>for use in infection control practices to reduce the<br>potential exposure to blood and body fluids. This<br>is a single use, disposable device(s), provided non-<br>sterile. | Identical |
| Mask Style | Flat pleated | Folded | The mask style is<br>different, but<br>performance is similar to<br>the predicate |
| Materials | | | |
| Cover Fabric(s) | Non-woven polypropylene; Melt blown non-woven<br>polypropylene filter | Non-woven polypropylene; Melt blown non-<br>woven polypropylene filter | Identical |
| Outer Cover Fabrics | 50g Non-woven Fabric | 50g Non-woven Fabric | Identical |
| Middle Layer-1 | 20g Melt blown Non-woven | 20g Melt blown Non-woven | Identical |
| Middle Layer-2 | 70g PET Non-woven Fabric | 70g PET Non-woven Fabric | Identical |
| Inner Facing | 30g Non-woven Fabric | 30g Non-woven Fabric | Identical |
| Nose Piece | Plastic | Silicone | The difference does not<br>impact device<br>performance |
| Ear Loops / Tie-on | Spandex | Spandex | Identical |
| Color | Blue and White | Blue and White | Similar |
| Design | Ear loop and tie-on | Ear loop and tie-on | Identical |
| Dimension (Width /<br>Length) | Small - 165mm × 70mm<br>Medium - 190mm × 80mm<br>Large - 210mm × 86mm | Small - 208x111 mm<br>Medium — 226x124 mm<br>Large - 250x138 mm<br>XL - 262x144 mm | The size difference and<br>lack of a small size mask<br>does not impact device<br>performance or safety |
| | | | |
| 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 | <6.0 mm H2O/cm2 | <6.0 mm H2O/cm2 | Identical |
| Flammability | Class I | Class I | Identical |
| Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation | Cytotoxicity<br>Sensitization<br>Irritation | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
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### Indications for Use -
The indications for use are identical for the proposed device when compared to the predicate. Discussion – Each device is indicated to cover a user's nose and mouth and provides a physical barrier to fluids and particulate materials.
### Technology and construction -
The design, fabrication, shape, size, etc. are equivalent to the predicate - AOK Tooling Ltd. - 039 Surgical Face Mask - K211956.
Discussion - This mask is a flat pleated style and covers a smaller surface area of the user's face. However, the difference in mask style of pleated vs. folded does not impact the substantial equivalence of the subject device to the predicate. There is no specific language within FDA product code FXX or its guidance document on the technological characteristics for a surgical mask that would relate to and/or limit the design to a flat pleated style (subject device) vs. vertical folded style. Thus, the difference in design of a pleated vs. folded mask does not impact the substantial equivalence of the subject device to the predicate. Our performance testing demonstrated that the subject device has similar performance to the predicate.
### Environment of Use -
The environments of use are identical to predicate - AOK Tooling Ltd. -039 Surgical Face Mask -K211956.
Discussion - The environments of use are the same.
### Patient Population -
The patient population of the proposed device and predicate - AOK Tooling Ltd. - 039 Surgical Face Mask - K211956.
Discussion - The identified patient population is equivalent to the predicate.
## Non-Clinical Testing Summary -
#### 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.
## Discussion of Differences –
There are no significant differences between the subject and predicate device, both of which are made by the same manufacturer for AOK Tooling. The main differences are the mask style (flatpleated vs. folded) and the size of the mask. Testing demonstrated that we are equivalent to the predicate device despite a difference in mask size and style.
#### Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.
