(233 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control, rather than for therapeutic intervention or treatment of disease.
No
Explanation: The device, a procedure/surgical mask, is intended to protect individuals from the transfer of microorganisms, body fluids, and particulate material. Its function is to provide a physical barrier, not to diagnose any medical condition or disease.
No
The device description clearly outlines physical components (spun-bond polypropylene, meltblown polypropylene filter, ear loops, nose wire, ties) and the performance studies focus on physical properties and filtration efficiency, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the masks (layers, materials, ear loops/ties, nose wire). This aligns with a physical barrier device, not a diagnostic device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the masks (fluid resistance, filtration efficiency, flammability), which are relevant to their intended use as a protective barrier. They do not involve evaluating diagnostic accuracy.
Therefore, based on the provided information, this device is a medical face mask intended for infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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.
Product codes
FXX
Device Description
The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.
The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green.
The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.
The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue.
The procedure masks are sold non-sterile and are intended to be single use, disposable device.
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
- 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, Standard Specification for Performance of Materials Used In Medical Face Masks
- ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks—Requirements and Test Methods;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
Key Metrics
Level 1 Masks (Model 68-8506-G & 68-8536-B):
Fluid Resistance: 32 out of 32 passed at 80 mmHg (3 lots) - PASS
Particulate Filtration Efficiency: 97.4%, 97.5%, 97.5% (Model 68-8506-G); 97.2%, 97.1%, 97.1% (Model 68-8536-B) - PASS (Acceptance criteria: ≥95%)
Bacterial Filtration Efficiency: 99.9% (3 lots) for both models - PASS (Acceptance criteria: ≥95%)
Differential Pressure: 2.9, 2.8, 2.7 mmH₂O/cm² (Model 68-8506-G); 3.7, 3.4, 3.7 mmH₂O/cm² (Model 68-8536-B) - PASS (Acceptance criteria:
§ 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
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May 20, 2021
Kenpax International Limited % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202899
Trade/Device Name: Procedure Mask/Surgical Mask (Ear loops and Tie-on) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2021 Received: February 11, 2021
Dear Ivy 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 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 Clarence W. Murray III, 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) K202899
Device Name Procedure Mask/ Surgical Mask Ear loops and Tie-on
Indications for Use (Describe)
The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
KENPAX INTERNATIONAL LIMITED Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China
510(K) Summary K202899
Date of summary prepared: 2021-05-20
A. Applicant:
KENPAX INTERNATIONAL LIMITED Address: Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
US agent: Solomon Chen 17947 PASEO DEL SOL Chino Hills, CA, US 91709 Phone: 909 4387898 Ext Email: Solomon@Aplusgroup.Net
B. Device:
Trade Name: Procedure mask/ Surgical Mask Common Name: SURGICAL MASK Model: ear loops & Tie-on
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K133070 Surgical Face Mask, Ear Loops, Model 101B, 101G, 136B, 136G, 137B, 137G Surgical Face Mask, Tie-on, Model 145B, 145G, 143B, 138G, 138G, 142B, 142G, 151B, 151G BH Medical Products Co., Ltd.
4
KENPAX INTERNATIONAL LIMITED Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China
D. Indications for use of the device:
The Procedure Masks/ Surgical 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(s), provided non-sterile.
E. Device Description:
The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.
The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green.
The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter.
The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue.
The procedure masks are sold non-sterile and are intended to be single use, disposable device. The difference
| Product Model | Feature | Layers (components) | Nose Wire | Earloop | Colorant |
|---|---|---|---|---|---|
| 68-8506-G | |||||
| ASTM Level 1 | Green | ||||
| Earloop | Outer: 22gsm SPP | Polyethylene | |||
| Coated Steel Wire | Polyester | Green | |||
| masterbatch | |||||
| PCG861 | |||||
| Middle: 22gsm MB | |||||
| Inner: 22gsm SPP | |||||
| 68-8508-G | |||||
| ASTM Level 3 | Green | ||||
| Earloop | Outer: 25gsm SPP | Polyethylene | |||
| Coated Steel Wire | Polyester | Green | |||
| masterbatch | |||||
| PCG861 | |||||
| Middle: 25gsm MB | |||||
| Inner: 25gsm SPP | |||||
| 68-8536-B | |||||
| ASTM Level 1 | Blue | ||||
| Tie-on | Outer: 22gsmSPP | Polyethylene | |||
| Coated Steel Wire | 40gsm SPP | Blue | |||
| masterbatch | |||||
| PCB1628 | |||||
| Middle: 22gsmMB | |||||
| Inner: 22gsmSPP | |||||
| 68-8538-B | |||||
| ASTM Level 3 | Blue | ||||
| Tie-on | Outer: 25gsmSPP | Polyethylene | |||
| Coated Steel Wire | 40gsm SPP | Blue | |||
| masterbatch | |||||
| PCB1628 | |||||
| Middle: 25gsmMB | |||||
| Inner: 25gsmSPP |
Detailed information of the four models please see below table.
F. Comparison with predicate device
The procedure masks/surgical masks are essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics.
5
| Table 1 General Comparison | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
| 510K # | K202899 | K133070 | |
| Manufacturer | KENPAX INTERNATIONAL LIMITED | BH Medical Products Co., Ltd. | |
| Model | |||
| Name | Procedure Mask/ Surgical Mask | ||
| Ear loops & tie-on | Surgical Face Mask, Ear Loops, Model | ||
| 101B, 101G, 136B, 136G, 137B, 137G | |||
| Surgical Face Mask, Tie-on, Model 145B, | |||
| 145G, 143B, 143G, 138B, 138G, 142B, | |||
| 142G, 151B, 151G | Similar | ||
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend Use/ | |||
| Indications | |||
| for Use | The Procedure Masks/ Surgical 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(s), provided non-sterile. | The 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(s), provided non-sterile. | Same | ||
| Materials | |||
| Outer layer | Spunbond Polypropylene | ||
| Level 1: 22gsm | |||
| Level 3: 25gsm | Spunbond Polypropylene | Same | |
| Inner layer | Spunbond Polypropylene | ||
| Level 1: 22gsm | |||
| Level 3: 25gsm | Spunbond Polypropylene | Same | |
| Filter layer | Melt-blown Polypropylene | ||
| Level 1: 22gsm | |||
| Level 3: 25gsm | Meltblown Polypropylene | Same | |
| Nose wire | Polyethylene Coated Steel Wire | Aluminum Wire | Different |
| Ear loops | Nylon, spandex | Polyester | Different |
| Tie-on | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Design | |||
| Features | Ear Loops, Tie-on | Ear Loops, Tie-On | Same |
| Mask style | Flat Pleated | Flat Pleated | Same |
| Color | Blue, green | Blue, Green | Same |
| Dimension | |||
| (Length) | 178±5mm | 3.5"+/-0.25" | |
| 4.2"+/-0.25" | Similar | ||
| Dimension | |||
| (Width) | 95±5mm | 6.8"+/-0.25" | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, non-irritating | Non-cytotoxic, Non-sensitizing, non-irritating | Same |
| Performance Testing (see Table 2) | |||
| ASTM level | Level 1, Level 3 | Level 1, Level 2, Level 3 | Similar |
| Fluid | |||
| Resistance | Meet ASTM F1862-17 | Meet ASTM F1862-07 | similar |
| Particulate | |||
| Filtration | |||
| Efficiency | Meet ASTM F2299-17 | Meet ASTM F2299-03 | Similar |
| Bacterial | |||
| Filtration | |||
| Efficiency | Meet ASTM F2101-19 | Meet ASTM F2101-07 | Similar |
| Differential | |||
| Pressure | Meet EN 14683: 2019, Annex C | Meet MIL-M36945C | Different |
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Similar |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, non-irritating | Non-cytotoxic, Non-sensitizing, non-irritating | Same |
6
KENPAX INTERNATIONAL LIMITERNATIONAL LIMITED
Flat 5, 5/F, Wing On Plaza, 62 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong, China
Table 2 Comparison of Performance testing
| Item | Proposed device (K202899) | Predicate device (K133070) | Acceptance criteria (Level 1) | Result | |
|---|---|---|---|---|---|
| Model 68-8506-G | Model 68-8536-B | ||||
| Fluid Resistance | 32 out of 32 passed at 80 mmHg, 3 lots | 32 out of 32 passed at 80 mmHg, 3 lots | Meet the ASTM F2100 Requirements for Level 1 Classification | 29 out of 32 pass at 80 mmHg | PASS |
| Particulate Filtration Efficiency | 97.4%, 97.5%, 97.5% | 97.2%, 97.1%, 97.1% | Meet the ASTM F2100 Requirements for Level 1 Classification | ≥95% | PASS |
| Bacterial Filtration Efficiency | 99.9% 3 lots | 99.9% 3 lots | Meet the ASTM F2100 Requirements for Level 1 Classification | ≥95% | PASS |
| Differential Pressure | 2.9, 2.8, 2.7 mmH₂O/cm² | 3.7, 3.4, 3.7 mmH₂O/cm² | Meet the ASTM F2100 Requirements for Level 1 Classification | 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, Standard Specification for Performance of Materials Used In Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks—Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
-
ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
H. Summary of Clinical Test
No clinical study is included in this submission.
l. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K133070.