(105 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 described as a surgical 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 mask intended to protect against the transfer of microorganisms and particulate material, not to diagnose any condition or disease.
No
The device description clearly outlines physical components (layers of polypropylene, ear loops, nose piece) and performance studies related to material properties and filtration, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting personnel and patients from the transfer of microorganisms, body fluids, and particulate material during medical and surgical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the mask's physical properties and barrier effectiveness (filtration, fluid resistance, breathability, etc.), as well as biocompatibility (cytotoxicity, irritation, sensitization). These are not diagnostic performance metrics.
- Key Metrics: The key metrics listed are related to the mask's filtration efficiency, fluid resistance, breathability, and safety for skin contact. These are not diagnostic metrics like sensitivity, specificity, or AUC.
In Vitro Diagnostics (IVDs) are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This surgical mask does not fit that definition.
N/A
Intended Use / Indications for Use
The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Masks, Model IIR, are non-sterile, single use, three-layers, flat-pleated style with ear loop and nose piece.
- The inner and outer layers of the Surgical Mask are made of Non-woven Spunbond Polypropylene for protection against fluid penetration that will not lint, teat or shred.
- The middle layer is made of highest quality Melt Blown Polypropylene Filter for optimal filtration and breathability, meeting ASTM Level 3 performance requirements.
- The sonically sealed ear loops are made of Polyester and Spandex to secure the mask over the user's face and mouth. They fit loosely and are attached to the mask to eliminate irritation.
- The adjustable nose piece is made of Aluminum forms strong seal for protection.
- The Surgical Masks will be provided in Blue. The device is not made from any natural rubber latex.
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
personnel during medical and 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 to demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
The tests include:
- Bacterial filtration efficiency (BFE) based on ASTM F2101-19: ≥98% acceptance criteria, Result: Pass (Average 99.9% for three lots tested).
- Sub-micron particulate efficiency at 0.1 µm (PFE) based on ASTM F2299: ≥98% acceptance criteria, Result: Pass (Average 99.74% - 99.86% for three lots tested).
- Resistant to penetration by synthetic blood based on ASTM F1862: @160 mm Hg acceptance criteria, Result: Pass (No Penetration at 160 mmHg for three lots tested).
- Differential Pressure (Δ P) based on EN 14683:2019+AC:2019:
§ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2021
BDC Dental Corporation Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K203425
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 19, 2021 Received: February 23, 2021
Dear Prithul Bom:
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 (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 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 Ryan Ortega, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203425
Device Name Surgical Mask
Indications for Use (Describe)
The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a 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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3
510(K) Summary
Date of Summary Prepared: March 3, 2021
510K Number: K203425
Establishment Registration Number (FEI): 3006985142
| Applicant: | BDC Dental Corporation Ltd.
Part 3, No.1 Guanchong Section, Shilian,
Shiqi Town, Panyu District, Guangzhou,
Guangdong CN 511450 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Jack Yang
Phone: 86-20-32052929
regulatoryaffairs@o-bdc.com |
| Official Correspondence: | Prithul Bom MBA, MS, RAC (US, EU), CSQI
Regulatory Technology Services
1000 Westgate Drive, Suite #510k,Saint Paul,
MN 55114, United States
prithul.bom@rts3pro.com
O 763 682 4139 |
| Device Name: | Surgical Mask |
| Device Classification Name: | Mask, Surgical |
| Trade name: | Surgical Mask |
| Classification: | Class II 21 CFR 878.4040 |
| Regulation Medical Specialty: | General and Plastic Surgery |
| Product Code: | FXX |
| Predicate Device: | K051291 - A. R. Medicom Inc. |
4
Indications for Use
The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a single use, disposable device, provided nonsterile.
Device Description
The Surgical Masks, Model IIR, are non-sterile, single use, three-layers, flat-pleated style with ear loop and nose piece.
- The inner and outer layers of the Surgical Mask are made of Non-woven Spunbond . Polypropylene for protection against fluid penetration that will not lint, teat or shred.
- . The middle layer is made of highest quality Melt Blown Polypropylene Filter for optimal filtration and breathability, meeting ASTM Level 3 performance requirements.
- . The sonically sealed ear loops are made of Polyester and Spandex to secure the mask over the user's face and mouth. They fit loosely and are attached to the mask to eliminate irritation.
- The adjustable nose piece is made of Aluminum forms strong seal for protection. .
- The Surgical Masks will be provided in Blue. The device is not made from any natural rubber latex.
| Features | Subject Device | Predicate Device | Comparis
on |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Manufacturer | BDC Dental Corporation Ltd. | A.R. Medicom Inc. | NA |
| Device Name | Surgical Mask | Non-Sterile Surgical Mask | NA |
| Model | IIR | Safe Mask SofSkin-2087 | NA |
| 510K | K203425 | K051291 | NA |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II , FXX (21 CFR878.4040) | Same |
| Intended Use | The surgical masks are intended to be worn by
personnel during medical and surgical
procedures to protect both the patient and the
operating personnel from transfer of
microorganisms, body fluids and particulate
material. The mask is a single use, disposable
device, provided nonsterile. | The medical/surgical mask listed below are
indicated as a protective nose and mouth
covering for health care workers and patients
involved in medical and surgical procedures.
The masks are indicated in any procedure or
situation where there is a risk of
microorganism, body fluid, and particulate
transfer. | Similar |
| Color | Blue | Blue | Same |
| Disposable | Yes | Yes | Same |
Comparison of Technological Characteristics with the Predicate Device
5
| Features | Subject Device | Predicate Device | Comparison | |||||
|---|---|---|---|---|---|---|---|---|
| Materials | Mask Body | Outer Material | Spunbond | |||||
| Polypropylene | ||||||||
| (SBPP) | Mask Body | Outer Material | Spunbond | |||||
| Polypropylene | ||||||||
| (SBPP) | Same | |||||||
| Filter Layer | Melt Blown | |||||||
| Polypropylene | ||||||||
| (MBPP) | Filter Layer | Melt Blown | ||||||
| Polypropylene | ||||||||
| (MBPP) | ||||||||
| Inner Layer | Spunbond | |||||||
| Polypropylene | ||||||||
| (SBPP) | Inner Layer | Spunbond | ||||||
| Polypropylene | ||||||||
| (SBPP) | ||||||||
| Nose-piece | Aluminum | Nose-piece | Aluminum | |||||
| Earloop | Polyester and Spandex | Earloop | Polyester and Spandex | |||||
| Earloop | ||||||||
| Style | Flat knitted earloop | Flat knitted earloop | ||||||
| Dimension | Body Size | Length | 170mm | Body Size | Length | 175 mm (6 ⅛") | Difference | |
| Width | 95mm | Width | 90,5 mm (3 ½") | |||||
| Earloop | Length | 165mm | Earloop | Length | 165 mm (6 ½") | |||
| Width | 3mm | Width | 3mm | |||||
| Pleat Depth | 14mm | Pleat Depth | 14 mm (⅝") | |||||
| Length of | ||||||||
| Nose-piece | 80mm | Length of | ||||||
| Nose-piece | 120 mm (4 ¾") |
| Performance | Subject Device | Predicate Device | Comparison | ||||
|---|---|---|---|---|---|---|---|
| ASTM | |||||||
| Requirements | ASTM LEVEL 3 | ||||||
| Test Criteria | ASTM LEVEL 3 | ||||||
| Test Results | ASTM | ||||||
| LEVEL 1 | ASTM | ||||||
| LEVEL 2 | ASTM | ||||||
| LEVEL 3 | NA | ||||||
| Bacterial filtration | |||||||
| efficiency(BFE) | ≥98% | LOT# KZ200708005 32/32 PASSED | |||||
| AVERAGE 99.9% | |||||||
| LOT# KZ200801002 32/32 PASSED | |||||||
| AVERAGE 99.9% | |||||||
| LOT# KZ200905006 32/32 PASSED | |||||||
| AVERAGE 99.9% | ≥95% | ≥98% | ≥98% | Similar | |||
| Sub-micron | |||||||
| particulate | |||||||
| efficiency at 0.1 µm | |||||||
| (PFE) | ≥98% | LOT# KZ200708005 32/32 PASSED | |||||
| AVERAGE 99.74% | |||||||
| LOT# KZ200801002 32/32 PASSED | |||||||
| AVERAGE 99.81% | |||||||
| LOT# KZ200905006 32/32 PASSED | |||||||
| AVERAGE 99.86% | ≥95% | ≥98% | ≥98% |
6
| Resistant to
penetration by
synthetic blood | @160 mm Hg | LOT# KZ200708005 32/32 PASSED
No Penetration at 160 mmHg
LOT # KZ200801002 32/32 PASSED
No Penetration at 160 mmHg
LOT# KZ200905006 32/32 PASSED
No Penetration at 160 mmHg | @80 mm
Hg | @120
mm Hg | @160
mm Hg | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|
| Differential
Pressure (Δ P) |