← Product Code [FXX](/productcode/FXX) · K203425 # Surgical Mask (K203425) _Bdc Dental Corporation , Ltd. · FXX · Mar 5, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K203425 ## Device Facts - **Applicant:** Bdc Dental Corporation , Ltd. - **Product Code:** [FXX](/productcode/FXX.md) - **Decision Date:** Mar 5, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** 3rd-Party Reviewed ## 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. ## Device Story Surgical mask (Model IIR) designed for single-use, non-sterile, disposable protection; worn by healthcare personnel during medical/surgical procedures. Construction: three-layer flat-pleated design; inner/outer layers of spunbond polypropylene; middle layer of melt-blown polypropylene filter; sonically sealed polyester/spandex ear loops; adjustable aluminum nose piece. Device functions as a physical barrier against microorganisms, body fluids, and particulates. Used in clinical settings; operated by healthcare professionals. Provides protection to both patient and wearer. Bench testing confirms ASTM Level 3 performance for bacterial/particulate filtration and fluid resistance. ## Clinical Evidence No clinical data. Bench testing only. Performance validated against ASTM F2100-20, ASTM F2101-19 (BFE ≥99.9%), ASTM F2299 (PFE ≥99.74%), ASTM F1862 (160 mmHg synthetic blood penetration), and EN 14683 (ΔP < 6.0 mm H2O/cm²). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10 (non-cytotoxic, non-irritating, non-sensitizing). ## Technological Characteristics Three-layer flat-pleated mask. Materials: Spunbond polypropylene (outer/inner), Melt-blown polypropylene (filter), Aluminum (nose piece), Polyester/Spandex (ear loops). ASTM F2100-20 Level 3 performance. Dimensions: 170mm x 95mm. Non-sterile, single-use. No natural rubber latex. ## Regulatory 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 - A. R. Medicom Inc. ([K051291](/device/K051291.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) # 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 # 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) | < 6.0 mm
H2O/cm² | LOT# KZ200708005 32/32 PASSED
AVERAGE 2.69
LOT# KZ200801002 32/32 PASSED
AVERAGE 3.28
LOT# KZ200905006 32/32 PASSED
AVERAGE 2.63 | < 4.0 mm
H2O/cm² | < 5.0 mm
H2O/cm² | < 5.0 mm
H2O/cm² | | | Flame Spread | Class I | LOT# KZ200708005 32/32 PASSED
DNI
LOT# KZ200801002 32/32 PASSED
DNI
LOT# KZ200905006 32/32 PASSED
DNI | | Class 1 | Same | | | Biocompatibility | ISO10993-5 and ISO10993-10;
Under the conditions of the studies employed, the device
is non-cytotoxic, non-sensitizing, and non-irritating. | | | ISO10993-5 and ISO10993-10;
Under the conditions of the studies
employed, the device is
non-cytotoxic, non-sensitizing, and
non-irritating. | Same | | Based on the comparison data aforementioned, the minor difference of dimension (length, width), length of nose piece and the differential pressure will not impact the safe and effectiveness of subjective device since the material, the function of the nose piece and major performance remains the same as the predicate device. # Non-clinical Test Performed The design and manufacturing process have been validated in accordance with standards and requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks –Premarket Notification [510(k)]. {7}------------------------------------------------ | Table 1 of Conformity to Standards | | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Standards | Standard Name | | [Rec# 6-425]
ASTM F2100-20 | Standard Specification for Performance of Materials Used in the
Medical Face Masks | | [Rec#6-427]
ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency
(BFE) of Medical Face Mask Materials, Using a Biological Aerosol of
Staphylococcus aureus | | [Rec#6-406]
ASTM F1862 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) | | ASTM F2299 F2299M-17 | Standard Test Method for Determining the Initial Efficiency of Materials
Used in Medical Face Masks to Penetration by Particulates Using Latex
Spheres | | [Rec#2-220]
ISO10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and
Testing. | | [Rec#2-245]
ISO10993-5 | Biological evaluation of medical devices -Part 5: Tests for in vitro
cytotoxicity. | | [Rec#2-174]
ISO10993-10 | Biological evaluation of medical devices -Part 10: Tests for irritation and
delayed-type hypersensitivity. | #### Table 2 of Performance Testing-Bench | ASTM Requirements | Acceptance Criteria- ASTM Level 3 | Result | |--------------------------------------------------------------------|-----------------------------------|--------| | Bacterial filtration
efficiency(BFE)
ASTM F2101-19 | ≥98% | Pass | | Sub-micron particulate
efficiency at 0.1 μm (PFE)
ASTM F2299 | ≥98% | Pass | | Resistant to penetration by
synthetic blood
ASTM F1862 | @160 mm Hg | Pass | | Differential Pressure (ΔP)
EN 14683:2019+AC:2019 | < 6.0 mm H2O/cm² | Pass | | Flame Spread
16 CFR part 1610(a) | Class 1 | Pass | {8}------------------------------------------------ | Item | Proposed Device | Acceptance Criteria | Result | |------------------------------|---------------------------------------------------------------------|---------------------|--------| | Cytotoxicity
ISO 10993-5 | Under the conditions of the study, the device
is non-cytotoxic. | Non-Cytotoxic | Pass | | Irritation
ISO 10993-10 | Under the conditions of the study, the device
is non-irritating | Non-Irritating | Pass | | Sensitization
ISO 10993-5 | Under the conditions of the study, the device
is non-sensitizing | Non-Sensitizing | Pass | Table 3 of Biocompatibility Testing # Summary of clinical performance data: No clinical data is required for this device. There are no major safety concerns. # Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device [K203425] is as safe, as effective, and performs as well as or better than the legally marketed predicate device [K051291] --- **Source:** [https://fda-staging.innolitics.com/device/K203425](https://fda-staging.innolitics.com/device/K203425) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com