(95 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of a surgical mask, with no mention of AI or ML technology.
No
The device is a surgical mask intended for barrier protection against fluids and particulates, not for treating a disease or condition.
No
The device is a surgical mask intended for barrier protection, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of materials like polypropylene, galvanized iron wire, nylon, and spandex, indicating it is a physical medical device (surgical mask) and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It's used in infection control practices to reduce exposure to blood and body fluids. This is a physical barrier function.
- Device Description: The description details the physical construction and materials of the mask, which are designed to filter airborne particles and fluids.
- Performance Studies and Key Metrics: The performance studies and metrics (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, Flammability, Cytotoxicity, Irritation and Sensitization) all relate to the physical barrier properties and biocompatibility of the mask.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
The Surgical Mask (Model: WK1701-02A, WK1701-03A and WK1701-04A) is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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.
The Model WK1701-02A is Level 1 barrier as ASTM F2100 requirements.
The Model WK1701-03A is Level 2 barrier as ASTM F2100 requirements.
The Model WK1701-04A is Level 3 barrier as ASTM F2100 requirements.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device(s) includes 3 models, which are WK1701-02A, WK1701-03A and WK1701-04A. Three of them all are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
All three models of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The proposed device(s) of Level 1, Level 2 and Level 3 have the same material. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated galvanized iron wire.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.
The proposed device(s) are 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)
Non clinical tests were conducted to verify that the proposed devices met all design specifications of the standard and test method described below for the 3 nonconsecutive lots with 32 samples per lot. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face > Masks.
- ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683-2019+AC:2019 Annex C, Medical face masks - Requirements and test methods;
- A 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;
- ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles;
- Bench Testing for the performance of Dimensions.
Key Results:
- ASTM F2101-19 (Bacterial Filtration Efficiency (BFE)):
- WK1701-02A (Level 1): 99.9% (Acceptance Criteria: >=95%)
- WK1701-03A (Level 2): 99.8 - 99.9% (Acceptance Criteria: >=98%)
- WK1701-04A (Level 3): 99.8 - 99.9% (Acceptance Criteria: >=98%)
- EN 14683-2019+AC:2019 Annex C (Differential Pressure (Delta P)):
- WK1701-02A (Level 1): Average 2.7 – 3.4 H2O/cm2 (Acceptance Criteria: =95%)
- WK1701-03A (Level 2): 99.41 - 99.98% (Acceptance Criteria: >=98%)
- WK1701-04A (Level 3): 99.58 - 99.77% (Acceptance Criteria: >=98%)
- ASTM F1862-17 (Resistance to Penetration by Synthetic Blood):
- WK1701-02A (Level 1): None Senn under 80 mmHg (Acceptance Criteria: 80 mmHg)
- WK1701-03A (Level 2): None Senn under 120 mmHg (Acceptance Criteria: 120 mmHg)
- WK1701-04A (Level 3): None Senn under 160 mmHg (Acceptance Criteria: 160 mmHg)
- 16 CFR 1610 (Flame spread performance):
- Class 1 (Ignited, but extinguished) (Acceptance Criteria: Class 1)
- ISO 10993-5: 2009 (Cytotoxicity potential):
- Under the conditions of this study, the test article have no potential toxicity to L-929 cells. (Acceptance Criteria: Non-cytotoxic)
- ISO 10993-10: 2010 (Irritation and Sensitization potential):
- The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test result showed that the response of the test article extract was categorized as negligible under the test condition. (Acceptance Criteria: Non-irritating and Non-sensitizing)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency (BFE): WK1701-02A (Level 1) 99.9%, WK1701-03A (Level 2) 99.8 - 99.9%, WK1701-04A (Level 3) 99.8 - 99.9%
Differential Pressure (Delta P): WK1701-02A (Level 1) Average 2.7 – 3.4 H2O/cm2, WK1701-03A (Level 2) Average 2.7 – 3.5 H2O/cm2, WK1701-04A (Level 3) Average 2.8 - 3.3 H2O/cm2
Sub-micron particulate filtration efficiency (PFE): WK1701-02A (Level 1) 99.45 - 99.97%, WK1701-03A (Level 2) 99.41 - 99.98%, WK1701-04A (Level 3) 99.58 - 99.77%
Resistance to Penetration by Synthetic Blood: WK1701-02A (Level 1) None Senn under 80 mmHg, WK1701-03A (Level 2) None Senn under 120 mmHg, WK1701-04A (Level 3) None Senn under 160 mmHg
Flammability: Class 1 (Ignited, but extinguished)
Cytotoxicity: No potential toxicity
Irritation: No evidence of causing delayed dermal contact sensitization, negligible response
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2021
Jiangmen Ningrui Medical Supplies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K212293
Trade/Device Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: July 19, 2020 Received: July 22, 2021
Dear Ray Wang:
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 (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.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Surgical Mask (Model:WK1701-02A, WK1701-03A and WK1701-04A)
Indications for Use (Describe)
The Surgical Mask (Model: WK1701-02A, WK1701-03A and WK1701-04A) is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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.
The Model WK1701-02A is Level 1 barrier as ASTM F2100 requirements.
The Model WK1701-03A is Level 2 barrier as ASTM F2100 requirements.
The Model WK1701-04A is Level 3 barrier as ASTM F2100 requirements.
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
The assigned 510(k) Number: K212293
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation:2021/10/25
-
- Sponsor Identification
JIANGMEN NINGRUI MEDICAL SUPPLIES CO., LTD.
F/4 & F/6, 2nd Building, No. 84, Xinning Avenue, Taicheng Town, Taishan City, Guangdong Province, 529200, CHINA.
Contact Person: Guorong Tan Position: General Manager Tel: +86-750-5522088 Fax: +86-750-5522088 Email: 13148901630@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
Common Name: Mask, Surgical
Regulatory Information Classification Name: Mask, Surgical Classification: 2 Product Code: FXX Regulation Number: 878.4040 Review Panel: General Hospital
Indication for use Statement:
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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.
The Model WK1701-02A is Level 1 barrier as ASTM F2100requirements.
The Model WK1701-03A is Level 1 barrier as ASTM F2100requirements.
The Model WK1701-04A is Level 1 barrier as ASTM F2100requirements.
Device Description: The proposed device(s) includes 3 models, which are WK1701-02A, WK1701-03A and WK1701-04A. Three of them all are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
All three models of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The proposed device(s) of Level 1, Level 2 and Level 3 have the same material. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene coated galvanized iron wire.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with nylon and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
5
| Model No. | Product
Dimension | Product Description | | Mask Style | | |
|------------|----------------------|---------------------|-----------|------------|---------|--------|
| | | Blue Mask | Ear Loops | Level 1 | Level 2 | Level3 |
| WK1701-02A | $17.5 \times 9.5$ cm | X | X | X | | |
| WK1701-03A | $17.5 \times 9.5$ cm | X | X | | X | |
| WK1701-04A | $17.5 \times 9.5$ cm | X | X | | | X |
The difference between the three models are the claimed Barrier Level.
5. Identification of Predicate Device(s)
Predicate Device K202491 Disposable Surgical Face Mask Jiangsu NewValue Medical Products Co., Ltd.
-
- Technological Characteristic Comparison
| ITEM | Proposed Device | Predicate Device K202491 | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level3 | ||
| Intended Use | The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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. | The Disposable Surgical Face Masks 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, provided non-sterile. | SAME | ||||
| Basic Design | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat-Pleated, 3 layers | SAME | ||||
| Materials | Outer Facing Layer | polypropylene spunbond fabric | Spun-bond Polypropylene | ||||
| non-woven fabric | Analysis | ||||||
| Middle Layer | polypropylene meltblown fabric | Melt-blown polypropylene | |||||
| Inner Facing Layer | polypropylene spunbond fabric | Spun-bond Polypropylene | |||||
| non-woven fabric | |||||||
| Nose Piece | polypropylene coated galvanized iron wire | Malleable iron wire with | |||||
| plastic covering | |||||||
| Ear Loops | nylon , spandex | Spandex Elastic cord | |||||
| Color | Blue | Blue | SAME | ||||
| Dimension | |||||||
| (Length, Width) | $17.5 cm ±5mm$ | 145×95mm (±5mm) | Similar | ||||
| $9.5 cm±3mm$ | 175×95mm (±5mm) | ||||||
| OTC use | Yes | Yes | SAME |
Table 1 General Comparison
6
| Single Use | Yes | Yes | SAME |
|---|---|---|---|
| Sterile | Non-sterile | Non-sterile | SAME |
Table 2 Performance Characteristic Comparison
| ITEM | Proposed Device | | | Predicate Device
K202491 | | | ASTM F2100
Requirements | | | Comparison
on |
|-----------------------------------------------|-----------------|----------|----------|---------------------------------------------------------|---------|---------|----------------------------|----------|----------|------------------|
| ASTM F2100
Level | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | SAME |
| Fluid Resistance
Performance
ASTM F1862 | 80 mmHg | 120 mmHg | 160 mmHg | Pass at 80 mmHg
Pass at 120 mmHg
Pass at 160 mmHg | | | 80 mmHg | 120 mmHg | 160 mmHg | SAME |
| Particulate
Filtration | ≥99% | ≥99% | ≥99% | Pass at >99.4% | | | ≥ 95% | ≥ 98% | ≥ 98% | |
| Efficiency ASTM
| F2299 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Bacterial | |||||||||
| Filtration | |||||||||
| Efficiency ASTM | |||||||||
| F2101 | ≥99% | ≥99% | ≥99% | Pass at ≥99.8% | ≥ 95% | ≥ 98% | ≥ 98% | ||
| Differential | |||||||||
| Pressure (Delta P) | |||||||||
| EN 14683:2019+ | |||||||||
| AC:2019 Annex C | ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity |
- A ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face > Masks.
-
ASTM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
-
EN 14683-2019+AC:2019 Annex C, Medical face masks - Requirements and test methods;
- A 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;
-
ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
-
Bench Testing for the performance of Dimensions.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F2101-19 | Verify the Bacterial | ||
| Filtration Efficiency (BFE) | |||
| performance of the subject | |||
| device. | Level 1: ≥95%; | ||
| Level 2: ≥98%; | |||
| Level 3: ≥98%; | WK1701-02A (Level 1) | ||
| 99.9% | |||
| WK1701-03A (Level 2) | |||
| 99.8 - 99.9% | |||
| WK1701-04A (Level 3) | |||
| 99.8 - 99.9% | |||
| EN 14683- | |||
| 2019+AC:2019 | |||
| Annex C | Verify the Differential | ||
| Pressure (Delta P) | |||
| performance of the subject | |||
| device. | Level 1: |