(105 days)
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.
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.
The document is a 510(k) premarket notification for a Surgical Mask (K203425). It describes the device's acceptance criteria and the studies performed to demonstrate its performance.
1. Table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (ASTM Level 3) | Reported Device Performance (Average) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | 99.9% | Pass |
| Sub-micron Particulate Efficiency (PFE) at 0.1 µm | ≥98% | 99.74% - 99.86% | Pass |
| Resistance to Penetration by Synthetic Blood | @160 mm Hg | No Penetration at 160 mmHg | Pass |
| Differential Pressure (ΔP) | < 6.0 mm H2O/cm² | 2.63 - 3.28 mm H2O/cm² | Pass |
| Flame Spread | Class 1 | DNI (Did Not Ignite) | Pass |
| Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Pass |
| Irritation | Non-Irritating | Non-Irritating | Pass |
| Sensitization | Non-Sensitizing | Non-Sensitizing | Pass |
2. Sample size used for the test set and the data provenance
For the performance tests (BFE, PFE, Resistant to synthetic blood, Differential pressure, Flame Spread), each lot tested (KZ200708005, KZ200801002, KZ200905006) had 32/32 passing results. The exact sample size per test within those 32 samples is not explicitly stated, but it implies all samples tested met the criteria. The data provenance is not explicitly stated in terms of country of origin, but the applicant is BDC Dental Corporation Ltd. in Guangzhou, Guangdong, China. The studies are non-clinical (bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the studies are non-clinical bench tests of a physical device (surgical mask) and do not involve human interpretation or expert ground truth. The "ground truth" is established by the standardized test methods themselves.
4. Adjudication method for the test set
This information is not applicable as there is no human interpretation or subjective assessment that would require adjudication. The results are quantitative measurements against predefined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical mask and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is established by standardized test methods (e.g., ASTM F2101-19 for BFE, ASTM F2299 for PFE, ASTM F1862 for synthetic blood resistance, EN 14683:2019+AC:2019 for Differential Pressure, 16 CFR part 1610(a) for Flame Spread, and ISO 10993 series for biocompatibility). These standards define the procedures and criteria for evaluating the physical and biological properties of the device.
8. The sample size for the training set
This information is not applicable. The device is a physical product (surgical mask) and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an algorithm.
{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 YangPhone: 86-20-32052929regulatoryaffairs@o-bdc.com |
| Official Correspondence: | Prithul Bom MBA, MS, RAC (US, EU), CSQIRegulatory Technology Services1000 Westgate Drive, Suite #510k,Saint Paul,MN 55114, United Statesprithul.bom@rts3pro.comO 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 | Comparison |
|---|---|---|---|
| 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 bypersonnel during medical and surgicalprocedures to protect both the patient and theoperating personnel from transfer ofmicroorganisms, body fluids and particulatematerial. The mask is a single use, disposabledevice, provided nonsterile. | The medical/surgical mask listed below areindicated as a protective nose and mouthcovering for health care workers and patientsinvolved in medical and surgical procedures.The masks are indicated in any procedure orsituation where there is a risk ofmicroorganism, body fluid, and particulatetransfer. | 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 | SpunbondPolypropylene(SBPP) | Mask Body | Outer Material | SpunbondPolypropylene(SBPP) | Same | |
| Filter Layer | Melt BlownPolypropylene(MBPP) | Filter Layer | Melt BlownPolypropylene(MBPP) | |||||
| Inner Layer | SpunbondPolypropylene(SBPP) | Inner Layer | SpunbondPolypropylene(SBPP) | |||||
| Nose-piece | Aluminum | Nose-piece | Aluminum | |||||
| Earloop | Polyester and Spandex | Earloop | Polyester and Spandex | |||||
| EarloopStyle | 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 ofNose-piece | 80mm | Length ofNose-piece | 120 mm (4 ¾") |
| Performance | Subject Device | Predicate Device | Comparison | ||||
|---|---|---|---|---|---|---|---|
| ASTMRequirements | ASTM LEVEL 3Test Criteria | ASTM LEVEL 3Test Results | ASTMLEVEL 1 | ASTMLEVEL 2 | ASTMLEVEL 3 | NA | |
| Bacterial filtrationefficiency(BFE) | ≥98% | LOT# KZ200708005 32/32 PASSEDAVERAGE 99.9%LOT# KZ200801002 32/32 PASSEDAVERAGE 99.9%LOT# KZ200905006 32/32 PASSEDAVERAGE 99.9% | ≥95% | ≥98% | ≥98% | Similar | |
| Sub-micronparticulateefficiency at 0.1 µm(PFE) | ≥98% | LOT# KZ200708005 32/32 PASSEDAVERAGE 99.74%LOT# KZ200801002 32/32 PASSEDAVERAGE 99.81%LOT# KZ200905006 32/32 PASSEDAVERAGE 99.86% | ≥95% | ≥98% | ≥98% |
{6}------------------------------------------------
| Resistant topenetration bysynthetic blood | @160 mm Hg | LOT# KZ200708005 32/32 PASSEDNo Penetration at 160 mmHgLOT # KZ200801002 32/32 PASSEDNo Penetration at 160 mmHgLOT# KZ200905006 32/32 PASSEDNo Penetration at 160 mmHg | @80 mmHg | @120mm Hg | @160mm Hg | |
|---|---|---|---|---|---|---|
| DifferentialPressure (Δ P) | < 6.0 mmH2O/cm² | LOT# KZ200708005 32/32 PASSEDAVERAGE 2.69LOT# KZ200801002 32/32 PASSEDAVERAGE 3.28LOT# KZ200905006 32/32 PASSEDAVERAGE 2.63 | < 4.0 mmH2O/cm² | < 5.0 mmH2O/cm² | < 5.0 mmH2O/cm² | |
| Flame Spread | Class I | LOT# KZ200708005 32/32 PASSEDDNILOT# KZ200801002 32/32 PASSEDDNILOT# KZ200905006 32/32 PASSEDDNI | Class 1 | Same | ||
| Biocompatibility | ISO10993-5 and ISO10993-10;Under the conditions of the studies employed, the deviceis non-cytotoxic, non-sensitizing, and non-irritating. | ISO10993-5 and ISO10993-10;Under the conditions of the studiesemployed, the device isnon-cytotoxic, non-sensitizing, andnon-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 theMedical 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 ofStaphylococcus aureus |
| [Rec#6-406]ASTM F1862 F1862M-17 | Standard Test Method for Resistance of Medical Face Masks topenetration by Synthetic Blood (Horizontal Projection of Fixed Volumeat a Known Velocity) |
| ASTM F2299 F2299M-17 | Standard Test Method for Determining the Initial Efficiency of MaterialsUsed in Medical Face Masks to Penetration by Particulates Using LatexSpheres |
| [Rec#2-220]ISO10993-1 | Biological evaluation of medical devices - Part 1: Evaluation andTesting. |
| [Rec#2-245]ISO10993-5 | Biological evaluation of medical devices -Part 5: Tests for in vitrocytotoxicity. |
| [Rec#2-174]ISO10993-10 | Biological evaluation of medical devices -Part 10: Tests for irritation anddelayed-type hypersensitivity. |
Table 2 of Performance Testing-Bench
| ASTM Requirements | Acceptance Criteria- ASTM Level 3 | Result |
|---|---|---|
| Bacterial filtrationefficiency(BFE)ASTM F2101-19 | ≥98% | Pass |
| Sub-micron particulateefficiency at 0.1 μm (PFE)ASTM F2299 | ≥98% | Pass |
| Resistant to penetration bysynthetic bloodASTM F1862 | @160 mm Hg | Pass |
| Differential Pressure (ΔP)EN 14683:2019+AC:2019 | < 6.0 mm H2O/cm² | Pass |
| Flame Spread16 CFR part 1610(a) | Class 1 | Pass |
{8}------------------------------------------------
| Item | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, the deviceis non-cytotoxic. | Non-Cytotoxic | Pass |
| IrritationISO 10993-10 | Under the conditions of the study, the deviceis non-irritating | Non-Irritating | Pass |
| SensitizationISO 10993-5 | Under the conditions of the study, the deviceis 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]
§ 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.