← Product Code [FXX](/productcode/FXX) · K210856 # Purism Disposable Surgical Mask (K210856) _Chuzhou Daddy'S Choice Science and Technology Co., Ltd. · FXX · Jul 28, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K210856 ## Device Facts - **Applicant:** Chuzhou Daddy'S Choice Science and Technology Co., Ltd. - **Product Code:** [FXX](/productcode/FXX.md) - **Decision Date:** Jul 28, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Device Story Purism Disposable Surgical Mask; 3-layer flat-pleated design; inner/outer layers non-woven fabric; middle layer melt-blown polypropylene filter; polyethylene/iron wire nose piece; elastic ear loops (non-latex). Device worn over mouth and nose to provide physical barrier against microorganisms, body fluids, and particulates. Used in clinical settings for infection control. Output is a protective barrier; helps reduce cross-contamination risk between patient and healthcare personnel. ## Clinical Evidence No clinical data. Bench testing only. Performance testing included fluid resistance (ASTM F1862, 94/96 pass at 160 mmHg), particulate filtration efficiency (ASTM F2299, 99.90% average), bacterial filtration efficiency (ASTM F2101, 99.88% average), differential pressure (EN 14683, 4.1 mmH2O/cm2), and flammability (16 CFR 1610, Class 1). Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed the device is non-cytotoxic, non-irritating, and non-sensitizing. ## Technological Characteristics 3-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (middle). Nose piece: polyethylene/iron wire. Ear loops: nylon/polyurethane composites. Dimensions: 17.5cm x 9.5cm. Non-sterile, single-use. ASTM F2100 Level 3 performance. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Disposable Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd ([K182514](/device/K182514.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### 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}------------------------------------------------ ## 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 | {6}------------------------------------------------ ## 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 <
6.0 mm H2O/cm² | 96/96 Samples Pass at Average
of 4.1mmH2O/cm2 | | Flammability
16 CFR 1610 | The purpose of this
standard is to reduce
danger of injury and loss
of life by providing, on a
national basis, standard
methods of testing and
rating the flammability of
textiles and textile
products for clothing use,
thereby prohibiting the use
of any dangerously | All samples must be
Class I | 96/96 Samples Pass for Class 1 | {7}------------------------------------------------ | flammable clothing
textiles. | | | | |---------------------------------|--|--|--| |---------------------------------|--|--|--| | Performance
testing
(Biocompatibility) | Purpose | Acceptance Criteria | Results | |------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------| | Cytotoxicity
ISO 10993-5: Biological
evaluation of medical devices
- Part 5: Tests for in vitro
cytotoxicity | Under the research
conditions,
determine
whether the target
device extract is
cytotoxic. | The sample is non-cytotoxic. | Under the conditions of
the study, the device is
noncytotoxic. | | Irritation
ISO 10993-10: Biological
evaluation of medical devices
-Part 10: Tests for irritation
and skin sensitization | Under the research
conditions,
determine whether
the non-polar and
polar extracts of the
target device are
sensitive. | The sample is non-irritating. | Under the conditions of
the study, the device is
nonirritating. | | Sensitization
ISO 10993-10: Biological
evaluation of medical
devices-Part 10: Tests for
irritation and skin
sensitization | Under the research
conditions,
determine whether
the non-polar and
polar extracts of the
target device are
irritating. | The sample is non-sensitizing. | Under the conditions of
the study, the device is
non-sensitizing | ### Table 3 Biocompatibility testing # 8. Discussion of Clinical Tests Performed: No clinical study is included in this submission. ## 2. Conclusions: Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Xiantao Zhibo Medical Product Disposable Face Mask cleared under K182514. --- **Source:** [https://fda-staging.innolitics.com/device/K210856](https://fda-staging.innolitics.com/device/K210856) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com