(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of surgical masks, with no mention of AI or ML.
No.
The device is intended to protect against the transfer of microorganisms, body fluids, and particulate material, which is a preventative rather than a therapeutic function.
No
Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms and body fluids. It does not perform any diagnostic function.
No
The device description clearly outlines physical components made of materials like polypropylene, polyester, spandex, PP, metal, and polyethylene terephthalate film (PET). It also details the construction of a three-layer mask with ear loops or ties, a nose piece, and optional anti-fog foam strips and eye shields. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical 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 function.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection. There is no mention of components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's ability to filter particles, resist fluid penetration, and its flammability and biocompatibility. These are all related to its barrier and protective function, not diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of any reagents, assays, or analytical processes that are characteristic of IVD devices.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
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
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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 Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
Bacterial Filtration Efficiency (ASTM F2101): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: >=98%; Lot 2: >=98%; Lot 3: >=98%.
Differential Pressure (EN 14683:2019 Annex C): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: =98%; Lot 2: >=98%; Lot 3: >=98%.
Resistance to Penetration by Synthetic Blood (ASTM F1862-17): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 32 out of 32 pass at 160 mmHg; Lot 2: 32 out of 32 pass at 160 mmHg; Lot 3: 32 out of 32 pass at 160 mmHg.
Flammability (16 CFR Part 1610-2008): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: Class 1; Lot 2: Class 1; Lot 3: Class 1.
Biocompatibility Testing (ISO 10993-1:2018):
Cytotoxicity (ISO 10993-5): Non-cytotoxic. Passed.
Sensitization (ISO 10993-10): Non-sensitizing. Passed.
Irritation (ISO 10993-10): Negligibly irritating. Passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency: >=98%
Differential Pressure: =98%
Resistance to Penetration by Synthetic Blood: 29 out of 32 pass at 160 mmHg (Acceptance Criteria), 32 out of 32 pass at 160 mmHg (Result)
Flammability: Class I
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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September 26, 2022
Jingzhou Haixin Green Cross Medical Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K222266
Trade/Device Name: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 28, 2022 Received: July 28, 2022
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.
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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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
Submission Number (if known)
K22266
Device Name
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 21st, July, 2022
A. Applicant:
Name: JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD. Address: YONGXING NORTH ROAD NO.2 JINGZHOU HUBEI, CHINA Contact: Lei Da Title: General Manager Tel: 86-27-82836722 Fax: 86-27-82770267 Email: inquiry@hh-greencross.com
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
B. Device: Trade Name: Surgical Mask Model: GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device: (Primary)
K210147 Proprietary Name: Unico High Performance Surgical Mask Unico High Performance Surgical Mask with Face Shield Common Name: Surgical Mask Classification Name: Surgical Mask (21 CFR 878.4040)
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Regulatory Class: II Product Code: FXX
D. Indications for use of the device:
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
F. Non-clinical Test Conclusion
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The Surgical Masks were tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Test Methodology | Purpose | Acceptance Criteria
for Level 3 Barrier | Result |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial Filtration
Efficiency
ASTM F2101 | Measure bacterial
filtration efficiency | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 32/lot
Lot 1: ≥98%
Lot 2: ≥98%
Lot 3: ≥98% |
| Differential Pressure
(mmH2O/cm²)
EN 14683:2019
Annex C | Determine breathability
of the mask | 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)
-
EN 14683, Medical Face Masks - Requirements and Test Methods
- A 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
Clinical Test Conclusion I.
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Medical Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210147.