(181 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML technologies.
No.
The device, a disposable surgical face mask, is intended for protection from microorganisms and fluids, not for treating or preventing a disease or condition in a patient.
No
The provided text explicitly states that the device is a "Disposable Surgical Face Mask" intended for protection from the transfer of microorganisms, body fluids, and particulate material. Its purpose is to act as a barrier, not to identify or diagnose any medical condition.
No
The device description clearly outlines physical components like layers of polypropylene, a nose piece made of aluminum wire, and ties or ear loops. The performance studies also focus on physical properties and material testing, not software validation.
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 against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask, again focusing on its barrier properties.
- Performance Studies and Key Metrics: The performance studies and metrics (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Synthetic Blood Penetration, etc.) are all related to the mask's ability to filter and block substances, not to diagnose a condition or analyze a sample from the human body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide information about a person's health status or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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(s), provided non- sterile.
Product codes
FXX
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose.
The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8.
The proposed device(s) are manufactured with three layers. the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance tests of surgical face masks were conducted.
Test Methodology: 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
Test Methodology Purpose: To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids.
Acceptance Criteria: >=98%
Results: Passed
Test Methodology: 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)
Test Methodology Purpose: To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates.
Acceptance Criteria: Level 3, No penetration at 160mmHg
Results: Passed
Test Methodology: 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. (General Plastic Surgery/General Hospital)
Test Methodology Purpose: To evaluate the bacterial filtration efficiency (BFE) of mask.
Acceptance Criteria: >=98%
Results: Passed
Test Methodology: MIL-M-36954C Military Specification - Mask, Surgical, Disposable 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
Test Methodology Purpose: To evaluate the flammability of mask.
Acceptance Criteria: Class 1, Resist ignition or flame ( Burn time >=3.5 seconds, IBE, or DNI )
Results: Passed
Test Methodology: Differential Pressure (Delta P) EN14683:2019, Annex C and ASTM F2100-19
Test Methodology Purpose: To measure the differential pressure of mask which is related to breathability.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 30, 2021
Anhui Cleanpro Pharmpack Co., Ltd. Chong Xiuming , Regulatory Manager Yeshan Industrial Zone Tianchang, Anhui 239300 CHINA
Re: K211696
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 20, 2021 Received: October 25, 2021
Dear Chong Xiuming:
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 avare 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.
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
1
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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211696
Device Name Disposable Surgical Face Mask
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(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
510(K) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92
Date prepared: October 20.2021
1. Submitter Name and Address:
| Owner Name: | Anhui Cleanpro Pharmpack Co., Ltd. |
|---|---|
| Establishment Registration Number : | 3016771217 |
| Address: | Yeshan Industrial Zone, Tianchang City, Anhui, China. |
| Post Code: | 239300 |
| Contactor Name: | Chong Xiuming |
| TEL: | +86-550-7981778 |
| E-mail: | carlchong@126.com |
Manufacturer Name: Anhui Cleanpro Pharmpack Co., Ltd.
| Address: | Yeshan Industrial Zone, Tianchang City, Anhui, China. |
|---|---|
| Post Code: | 239300 |
US Agent:
| US Agent: | LI QIAN |
|---|---|
| Address: | 4319 Abbotts Bridge Rd STE 3 Duluth Duluth, GA US 30097 |
| TEL: | 404 4261248 Ext |
| Email : | Li@Carelifeusa.Com |
2. Submission Devices Information:
Trade/Proprietary Name: Disposable Surgical Face Mask Common Name: Disposable Surgical Face Mask Classification name: Surgical Apparel. Class: II. Product codes: FXX Submission Type: 510(K) Regulation Number: 21 CFR 878.4040
3. Predicate Devices Information:
Company Name: BH Medical Products Co., Ltd. Address: No.90 Zhangjia Industrial Area, Xiling, Changzhou, Jiangsu, China 213024 Trade Name: Surgical Face Mask Class: II.
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Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
510(K) Number: K133070 Product codes: FXX Submission Type: 510(K) Regulation Number: 21 CFR 878.4040
4.Devices Description:
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose.
The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8.
The proposed device(s) are manufactured with three layers. the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
5. Indications for use:
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(s), provided nonsterile.
6. Comparison of technological characteristics with the predicate:
The primary components of The Disposable Surgical Face Masks are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicate devices.
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Anhui Cleanpro Pharmpack Co., Ltd. Yeshan Industrial Zone, Tianchang City, Anhui Provice, China. [Disposable Surgical Face Mask]
Table 1 General Comparison
| Element of Comparison | Submission Device | Predicate Device
K133070 | Comparison | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------|
| Manufacturer | Anhui Cleanpro
Pharmpack Co., Ltd. | BH Medical Products
Co., Ltd. | / | |
| 510 (k) | K211696 | K133070 | / | |
| Proprietary or Model Name | Surgical Face Mask, Ear
Loops, Model:CRWKE001
Surgical Face Mask, Tie-on,
Model:CRWKT001 | 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
(21CFR878.4040) | Class II Device, FXX
(21CFR878.4040) | Same | |
| Intended use/Indications for
Use | 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(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 | |
| Ear loop model and
Tie-on model | Ear Loops, Tie-On | Ear Loops, Tie-On | Same | |
| Mask styles | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same | |
| Materials | Outer Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle Layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| | Inner Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose Piece | Malleable aluminum wire | Malleable aluminum wire | Same |
| | Ear Loops | Polyester | Polyester | Same |
| Design features | | Color : Blue | Color : Blue, Green | Similar |
| Dimension (Length) | | 17.5 cm +/- 0.5cm | 6.8"+/-0.25" | Similar |
| Dimension (Width) | | 9.5 cm +/- 0.5cm | 3.5"+/-0.25"
4.2"+/-0.25" | Similar |
| OTC use | | Yes | Yes | Same |
| Single Use | | Yes | Yes | Same |
| Sterile | | No | No | Same |
| ASTM F2100 Level | | Level 3 | Level 1、Level 2、 Level 3 | Similar |
| Element of
Comparison | Submission Device | Predicate Device
K133070 | ASTM F2100
Requirements
for Level 3
Classification | Comparison |
| Fluid Resistance
Performance
ASTM F1862 | 1、LOT NO.: CR202101
132,32 out of 32 pass at64,32 out of 32 pass at
160 mmHg
2、LOT NO.: CR202102
33
160 mmHg
3、LOT NO.: CR202103
6596,32 out of 32 pass at32: ≥ 99%
160 mmHg | Pass | 29 out of 32 pass
at
160 mmHg | Same |
| Particulate
Filtration
Efficiency ASTM
F2299 | 1、LOT NO.: CR202101
1
2、LOT NO.: CR202102
3364: ≥ 99%96: ≥ 99% | ≥ 98% | ≥ 98% | Same |
3、LOT NO.: CR202103
65
| Bacterial Filtration
Efficiency ASTM
F2101 | 1、LOT NO.: CR202101
132: ≥ 99%64: ≥ 99%
2、LOT NO.: CR202102
33
3、LOT NO.: CR202103
6596: ≥ 99% | ≥98% | ≥98% | Same |32:
| Differential
Pressure (DeltaP)
MIL-M-36954C | 1、LOT NO.: CR202101
1