(127 days)
Not Found
No
The device is a simple disposable surgical mask with no mention of AI/ML capabilities in its description, intended use, or performance studies.
No
The device is a surgical mask intended for infection control and protection from microorganisms and fluid transfer, rather than for treating a disease or condition.
No
The device, Purism Disposable Surgical Masks, is intended to protect against transfer of microorganisms and particulate material, and reduce exposure to blood and body fluids. It is a physical barrier and performs no diagnostic function.
No
The device is a physical surgical mask made of non-woven and melt-blown fabric, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Purism Disposable Surgical Mask is a physical barrier intended to protect against the transfer of microorganisms, body fluids, and particulate material. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states its purpose is for protection and infection control by being worn on the face.
- Device Description: The description details the physical construction of the mask, not any diagnostic testing components.
- Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Purism Disposable Surgical Mask is a medical device, but it falls under the category of a personal protective equipment (PPE) or a barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Purism Disposable 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, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Purism Disposable Surgical Masks are manufactured with 3 layers, the inner facing layer and outer facing layer are composed of non-woven fabric, the middle layer is made up of melt-blown fabric. The surgical masks are single use, flat-folded with ear loops. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The Surgical Masks are sold non-sterile and are intended to be disposable mask.
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 following testing was conducted to demonstrate that the subject device met the acceptance criteria or the performance specification of the test methodology or standard provided in the tables below:
Performance Testing Standard: Fluid Resistance Performance ASTM F1862
Purpose: To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood.
Acceptance Criteria: At least 29 out of 32 specimens per lot show passing results at 160 mmHg
Results: 94 out of 96 pass at 160mmHg
Performance Testing Standard: Particulate Filtration Efficiency ASTM F2299
Purpose: To determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex. Spheres
Acceptance Criteria: ≥ 98% Average PFE for all samples tested
Results: 96/96 Samples Pass at Average of 99.90%
Performance Testing Standard: Bacterial Filtration Efficiency ASTM F2101
Purpose: To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
Acceptance Criteria: ≥ 98% Average BFE for all samples tested
Results: 96/96 Samples Pass at Average of 99.88%
Performance Testing Standard: Differential Pressure (Delta P) EN 14683
Purpose: To determine the pressure required to breathe through the final manufactured face mask.
Acceptance Criteria: Samples must be
§ 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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28, 2021
Chuzhou Daddy's Choice Science and Technology Co., Ltd. % Nickita Alexiades Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck. New York 11021
Re: K210856
Trade/Device Name: Purism Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021
Dear Nickita Alexiades:
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.
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
1
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, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210856
Device Name Purism Disposable Surgical Mask
Indications for Use (Describe)
The Purism Disposable 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, 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
The assigned 510(k) number is K210856
1. Submitter's Identification:
| Manufacturer: | Chuzhou Daddy's Choice Science and Technology Co., Ltd. |
|---|---|
| Address: | Middle of Nanjing Road,Langya District,Chuzhou City,Anhui,China |
| Contact Person: | Chaozhong Song |
| Tel: | +8618310114997 |
| Email: | scz1976@163.com |
| Date Summary Prepared: | March 18, 2021 |
| Official Correspondent: | Mr. Nickita Alexiades |
| Mdi Consultants, Inc. | |
| Address: | 55 Northern Blvd. Suite 200, Great Neck, NY, United States |
| Tel: | 201-220-2152 |
| Email: | nickita@mdiconsultants.com |
2. Name of the Device:
Device Trade Name: Purism Disposable Surgical Mask Classification Name: Surgical Face Mask Regulatory Class: II Product Code: FXX Regulation Name: Surgical Apparel Regulation Number: 878.4040
3. Information for the 510(k) Cleared Device (Predicate Device):
K182514 Disposable Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd
4. Device Description:
The Purism Disposable Surgical Masks are manufactured with 3 layers, the inner facing layer and outer facing layer are composed of non-woven fabric, the middle layer is made up of melt-blown fabric. The surgical masks are single use, flat-folded with ear loops. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The Surgical Masks are sold non-sterile and are intended to be disposable mask.
5. Indications for Use:
4
The Purism Disposable 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, provided non-sterile.
| Table 1: Technological Characteristics Comparison | ||||
|---|---|---|---|---|
| Device | Proposed device | Predicate device | Result | |
| 510(k) | K210856 | K182514 | - | |
| Manufacturer | Chuzhou Daddy's Choice Science and Technology Co., Ltd | Xiantao Zhibo Non-woven Products Co., Ltd | - | |
| Product Name | Purism Disposable Surgical Mask | Surgical Face Mask | Similar | |
| Classification | Class II Device FXX (21 CFR878.4040) | Class II Device FXX (21 CFR878.4040) | Similar | |
| Indications for Use | The Purism Disposable 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, 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. | Similar | |
| Material | Outer facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Similar | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
6. Technological Characteristics Comparison:
| Nose
piece | Polyethylene
and iron wire | Malleable aluminum
wire | Similar |
| --------------- | ------------------------------- | ---------------------------- | --------- |
|---|
5
| | Ear loops | Nylon / Polyurethane
composites | Polyester | Similar |
|-----------------------------|-----------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------|
| Model | | Ear
loops 3-layers
Flat Pleated | Ear loops
3-layers
Flat Pleated | Similar |
| Color | | Blue | White | Different |
| Dimension(width) | | $17.5cm±0.5cm$ | $17.5cm±1cm$ | Similar |
| Dimension(length) | | $9.5cm±0.5cm$ | $9.5cm±1cm$ | Similar |
| OTC use | | Yes | Yes | Similar |
| Sterility | | Non-sterile | Non-sterile | Similar |
| Use | | Single Use,
Disposable | Single Use,
Disposable | Similar |
| ASTM F2100 Level | | Level 3 | Level 2 | Similar |
| Non-Clinical Testing | | ASTM
F1862
ASTM
F2299
ASTM
F2100
ASTM
F2101
EN14683
16 CFR 1610 | ASTM F1862
ASTM F2299
ASTM F2100
ASTM F2101
16 CFR 1610 | Similar |
| Biocompatibility
Testing | | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | Similar |
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7. Summary of Non-Clinical Tests:
The following testing was conducted to demonstrate that the subject device met the acceptance criteria or the performance specification of the test methodology or standard provided in the tables below:
| Performance Testing
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | To evaluate the resistance | ||
| of medical face masks to | |||
| penetration by the impact | |||
| of a small volume (~2 | |||
| mL) of a high-velocity | |||
| stream of synthetic blood. | At least 29 out of 32 | ||
| specimens per lot | |||
| show passing results | |||
| at 160 mmHg | 94 out of 96 pass at | ||
| 160mmHg | |||
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | To determine the Initial | ||
| Efficiency of Materials | |||
| Used in Medical Face | |||
| Masks to Penetration by | |||
| Particulates Using Latex. | |||
| Spheres | ≥ 98% Average PFE | ||
| for all samples tested | 96/96 Samples Pass at Average | ||
| of 99.90% | |||
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | To measure the bacterial | ||
| filtration efficiency (BFE) | |||
| of medical face mask | |||
| materials, employing a | |||
| ratio of the upstream | |||
| bacterial challenge to | |||
| downstream residual | |||
| concentration to determine | |||
| filtration efficiency of | |||
| medical face mask | |||
| materials. | ≥ 98% Average BFE | ||
| for all samples tested | 96/96 Samples Pass at Average | ||
| of 99.88% | |||
| Differential Pressure | |||
| (Delta | |||
| P) | |||
| EN 14683 | To determine the pressure | ||
| required to breathe | |||
| through the final | |||
| manufactured face mask. | Samples must be |