(630 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of surgical face masks, with no mention of AI or ML.
No
The description states its purpose is for protection and infection control, not for treating or preventing a disease.
No
The device is a surgical face mask, which is used for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (pleated layers, earloops, nose piece) and performance studies relate to material properties and filtration, indicating a physical medical device, not software.
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 masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical components of a mask (layers, earloops, nose piece). There is no mention of reagents, assays, or any components used to test samples from the human body.
- Performance Studies: The performance studies listed (particulate penetration, synthetic blood resistance, bacterial filtration efficiency, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask, not diagnostic performance.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
The surqical face masks are pleated 3 plys sinqle use, disposable masks. Inner layers and outer layers are made of spun-bond polypropylene. Middle layer is made of melt blown polypropylene filter. Earloops are Knitted Elastic loops (not made with natural rubber latex). Tieon is made of spun-bond polypropylene. The nose piece is a malleable aluminum wire.
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)
The performance tests of surqical face masks were conducted.
ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F1862-07 Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
ASTM F2101-07 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (General Plastic Surgery/General Hospital)
MIL-M-36954C Military Specification - Mask, Surgical, Disposable
16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
ISO 10993-1: 2009, Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
ISO 10993-5: 2009. Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2015
BH Medical Products Co., Ltd. C/O Ms. Di Wu MEDevice Union, Ltd. Regulatory Affairs Specialist 12F Weiya Building, No. 29 Suzhou Street Haidian District Beijing 100080
Re: K133070
Trade/Device Name: 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
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: II Product Code: FXX Dated: May 17, 2015 Received: May 22, 2015
Dear Ms. Wu:
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. 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
Page 2 - Ms. Wu
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133070
Device Name
Surgical Face Mask, Ear Loops, Model 101B, 101G, 136B, 136G, 137B, 137G Surgical Face Mask, Tie-on, Model 145B, 145G, 143G, 138G, 138G, 142B, 142G, 151B, 151G,
Indications for Use (Describe)
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.
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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510(k) Summary
Summary Prepared Date: 06/12/2015
Submission Sponsor (Manufacturer):
BH Medical Products Co., Ltd. No.90 Zhangjia Industrial Area, Xiling Changzhou , Jiangsu, China 213024
Submission Correspondent (Agent):
Di Wu Requlatory Affairs Specialist
MEDevice China, Ltd. 12F Weiya Building, No.29 Suzhou Street, Haidian District Beijing, China 100080 Email: info@medevicechina.com www.medevicechina.com Tel: +086 (010) 57846520
Trade/Device Name:
Surqical 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,
Device Class: II Classification Name: Mask, Surqical Regulation Number: 21 CFR 878.4040 Product Code: FXX Review Panel: General & Plastic Surgery Predicate Device:
- K131879 ● KIMBERLY-CLARK CORP KIMBERLY-CLARK, KC300 Mask
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Device Description:
The surqical face masks are pleated 3 plys sinqle use, disposable masks. Inner layers and outer layers are made of spun-bond polypropylene. Middle layer is made of melt blown polypropylene filter. Earloops are Knitted Elastic loops (not made with natural rubber latex). Tieon is made of spun-bond polypropylene. The nose piece is a malleable aluminum wire.
Over the counter use: Yes Duration and type of contact: Direct contact, less than 24 hours, skin contact Single use disposable device: Yes Sterile: No
Intended Use:
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.
Comparison to Predicate Devices:
The surgical face masks are essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics.
| Descriptive
| Information | Proposed Device | Predicate Device | SE |
|---|---|---|---|
| 510(k) Number | K133070 | K131879 | N/A |
| Manufacturer | BH Medical Products Co., Ltd | Kimberly-Clark Corp | N/A |
| Proprietary or | |||
| Model Name | 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, | Face Masks, KC300 | N/A |
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| 151B, 151G. | |||||
|---|---|---|---|---|---|
| Indication for Use | 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 | |||||
| facemasks 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 Kimberly-Clark, Face | ||||
| Mask(s) is 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 of the | |||||
| wearer to blood and body | |||||
| fluids. The Kimberly- | |||||
| Clark, face mask(s) is a | |||||
| single use, disposable | |||||
| device(s), provided non- | |||||
| sterile. | Same | ||||
| ASTM Level | 1 | 2 | 3 | 3 | similar |
| Design feature | Tie-on/ | ||||
| earloop | Tie-on/ | ||||
| earloop | Tie-on/ | ||||
| earloop | Tie-on/earloop | same | |||
| Mask styles | 3 flat pleated | 4 flat pleated | similar | ||
| Product | |||||
| Performance | |||||
| Specifications | Meet ASTM F1862-07 | ||||
| Meet ASTM F2101-07 | |||||
| Meet ASTM F2299-03 | |||||
| Meet MIL-M-36954C | |||||
| Meet 16 CFR Part 1610 | Meet ASTM F1862-07 | ||||
| Meet ASTM F2101-07 | |||||
| Meet ASTM F2299-03 | |||||
| Meet MIL-M-36954C | |||||
| Meet 16 CFR Part 1610 | similar | ||||
| 16 CFR Part 1610 | |||||
| Flammability class | Class 1 | Class 1 | similar | ||
| Single Use | Yes | Yes | same | ||
| Disposable | Yes | Yes | same | ||
| Non-sterile | Yes | Yes | same | ||
| Outer Facing Layer | Spunbond Polypropylene | Polyethylene/Polyester, | |||
| with ink print | same | ||||
| Middle Layer | Meltblown Polypropylene | Spunbond Middle Layer: | |||
| Polypropylene spunbond | |||||
| Meltblown Middle Layer: | |||||
| Polypropylene Meltblown | similar | ||||
| Inner Facing Layer | |||||
| Binding | Spunbond Polypropylene | ||||
| Spunbond Polypropylene | Polyethylene/Polyester | ||||
| Polyester spunlace, | |||||
| or | similar |
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| Polypropylene spunbond | |||
|---|---|---|---|
| Nosepiece | Aluminum Wire | Unknown | same |
| Earloop | Polyester | Polyester/Lycra Knitted | same |
| Tieon | Spunbond Polypropylene | Polypropylene spunbond | similar |
| Offered as fog free | - | Yes | - |
| Offered with Visor | - | Yes | - |
| Color | Blue, Green | Unknown | similar |
| Dimension (width) | 6.8"+/-0.25", | 6.5"+/-0.75" | similar |
| Dimension (length) | 3.5"+/-0.25" | ||
| 4.2"+/-0.25" | 4.5"+/-0.75" | similar | |
| Over the counter | |||
| use | Yes | Yes | |
| Biocompatibility | Non-cytotoxic, Non-sensitizer, | ||
| non-irritant | Non-cytotoxic, Non- | ||
| sensitizing, non-irritating |
Discussion of Non-Clinical Tests Performed:
The performance tests of surqical face masks were conducted.
ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F1862-07 Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
ASTM F2101-07 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (Bfe) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus. (General Plastic Surgery/General Hospital)
MIL-M-36954C Military Specification - Mask, Surgical, Disposable
16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
ISO 10993-1: 2009, Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
ISO 10993-5: 2009. Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
7
ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
Therefore, we conclude that the surgical face masks are both safe and effective for its intended use.
Discussion of Clinical Tests Performed:
None
Conclusion:
The device is as safe and as effective for their intended use as the predicate device.