(296 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the mask is for protection and infection control, not for treating any specific medical condition or disease.
No
This device is a medical face 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 a physical, multi-layer surgical mask made of materials like polypropylene, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, filter, nose piece, ear loops). It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as filtration efficiency, fluid resistance, flammability, and biocompatibility (cytotoxicity, irritation, sensitization). These are tests of the device's ability to function as a barrier, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
In summary, the GD Disposable Medical Face Mask is a personal protective equipment (PPE) designed to prevent the spread of contaminants, not a device used to diagnose diseases or conditions by testing samples.
N/A
Intended Use / Indications for Use
The GD Disposable Medical Face Mask 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The GD Disposable Medical Face Mask is a single use multi-layer Level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel / Healthcare setting (implied by "healthcare personnel" and "infection control practices")
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)
Nonclinical tests were performed.
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity: Safety Testing, Non-Cytotoxic, Pass
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: Safety Testing, Non-Irritating and Non-Sensitizing, Pass
- 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): Barrier Testing, Pass at 120mm Hg, Pass
- 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;: Barrier Testing, ≥98%, Pass
- ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;: Barrier Testing, ≥98%, Pass
- EN 14683: European standard for face masks: Physical Testing, 99.9%
- Flammability Class: Class I
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
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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April 16, 2021 Jiangsu Guangda Medical Material Group Co., Ltd. % W. Victoria Rogers Regulatory Affairs Consultant Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K201718
Trade/Device Name: GD Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 12, 2021
Dear W. Victoria Rogers:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 15, 2021. Specifically, FDA is updating this SE Letter as an administrative correction due to omission of the signature in the original SE letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarence W. Murray III, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-0270 or Clarence.Murray@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
For Clarence W. Murray III, Ph.D. Acting 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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
Image /page/1/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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 15, 2021
Jiangsu Guangda Medical Material Group Co., Ltd. % W. Victoria Rogers Regulatory Affairs Consultant Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K201718
Trade/Device Name: GD Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 12, 2021
Dear W. Victoria Rogers:
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.
2
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 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, Ph.D. Acting 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
3
Indications for Use
510(k) Number (if known)
K201718
Device Name GD Disposable Medical Face Mask
Indications for Use (Describe)
The GD Disposable Medical Face Mask 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 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)
| Residential Use (Part 21 CFR 601 Subpart E) | |
|---|---|
| Over-The-Counter Use (21 CFR 601 Subpart C) |
__ 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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the GD Disposable Medical Face Mask 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| 510(k) Number: | K201718 |
|---|---|
| Sponsor: | Jiangsu Guangda Medical Material Group Co., Ltd. |
| No. 18 Baochang Road North Libao Town, Haian County, | |
| Jiangsu Province, China | |
| Contact Person: | George Zhang |
| President | |
| Telephone: 86-513-88219002 | |
| Designated Submission | |
| Correspondent: | W. Victoria Rogers |
| Rogers Consulting | |
| 11110 Arranmore Cove | |
| Roanoke, Indiana 46783 | |
| 574-265-8356 | |
| Date: | 6 April 2021 |
| Subject Device: | Trade Name: GD Disposable Medical Face Mask |
| Common Name: Surgical Facemask | |
| Classification Name: | |
| • FXX- Surgical Apparel (21 CFR 878.4040) | |
| Predicate Device(s): | K160269 Surgical Face Masks (Ear Loops and Tie-on) SAN-M Package Co., LTD. |
5
| Purpose and Device Description: | The GD Disposable Medical Face Mask is a single use multi-layer Level 2 surgical mask. It houses a meltblown polypropylene filter between an outer and inner layer of spunbond polypropylene that covers the nose and mouth of the end user and held in place by a pliable nose piece and ear loops. Contact duration is less than 24 hours. |
|---|---|
| Intended Use and Indications for Use: | The GD Disposable Medical Face Mask 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 to blood and body fluids. This is a single use, disposable device, provided non-sterile. |
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
| | GD Level 2 Mask
K201718 | Surgical Face Masks
(Ear Loops and Tie-on),
K160269 | Remark |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use/
Indications for
Use | The GD Disposable Medical
Face Mask 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 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 |
| | Materials | | |
| Outer Materials | Polypropylene spunbond | Polypropylene | Similar |
| Filter Media | Polypropylene meltdown | 1. Polypropylene
spunbond | Similar |
6
| | | 2. Polypropylene
meltdown | |
|--------------------------------------------------|------------------------------|-----------------------------------------------------------|---------|
| Inner Material | Polypropylene spunbond | Polypropylene | Similar |
| Nose Piece | Malleable aluminum wire | Polyethylene coated
steel wire | Similar |
| Ear Loops | Polyester | Polyester | Similar |
| Specifications | Length: 175mm
Width: 95mm | Length: $175 \pm 5$ mm
Width: $90 \pm 3$ mm | Similar |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Design Features | White | White or Blue
Visor option: Polyester | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Performance Testing | | | |
| | ASTM F2100 – Level 2 | | |
| | | | |
| | GD Level 2 Mask | Surgical Face Masks
(Ear Loops and Tie-on),
K160269 | Remarks |
| Fluid resistance
ASTM F1862 | Pass at 120 mmHg | Pass at 120 mmHg | Same |
| Particle Filtration
Efficiency
ASM F2299 | Pass at 99.4% | Pass at 99.6% | Similar |
| Bacterial Filtration
Efficiency
ASTM F2101 | Pass at >99.9% | Pass at >98% | Similar |
| Flammability Class
16 CFR 1610 | Class I | Class I | Same |
| Biocompatibility Testing | |||
|---|---|---|---|
| GD Level 2 Mask | Surgical Face Masks (Ear Loops and Tie-on), K160269 | Results | |
| Cytotoxicity | |||
| ISO 10993-5 | Comply with ISO 10993-5. | ||
| Under the conditions of the | |||
| study, the proposed device | |||
| extract was determined to be | |||
| non-cytotoxic | Comply with ISO 10993-5. | ||
| Under the conditions of the | |||
| study, the proposed device | |||
| extract was determined to be | |||
| non-cytotoxic | Non- | ||
| cytotoxic | |||
| Irritation | |||
| ISO 10993-10 | Comply with ISO 10993-10. | ||
| Under the conditions of the | |||
| study, the proposed device | |||
| extract was determined to be | |||
| non-irritating | Comply with ISO 10993-10. | ||
| Under the conditions of the | |||
| study, the proposed device | |||
| extract was determined to be | |||
| non-irritating | Non- | ||
| irritating |
7
| Sensitization
ISO 10993-10 | Comply with ISO 10993-10.
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing | Comply with ISO 10993-10.
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing | Non-
sensitizing |
| ------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- | --------------------- |
|---|
Summary of Performance Data
(Nonclinical and/or Clinical)
| Name of the Test
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5: 2009 | |||
| Biological Evaluation Of | |||
| Medical Devices -- Part 5: | |||
| Tests For In Vitro | |||
| Cytotoxicity | Safety Testing | Non-Cytotoxic | Pass |
| ISO 10993-10: 2010 | |||
| Biological Evaluation Of | |||
| Medical Devices - Part 10: | |||
| Tests For Irritation And | |||
| Skin Sensitization | Safety Testing | Non-Irritating and | |
| Non-Sensitizing | Pass | ||
| ASTM F2100-19, Standard Specification For Performance Of Materials | |||
| Used In Medical Face Masks | |||
| 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) | Barrier Testing | Pass at 120mm Hg | Pass |
| 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; | Barrier Testing | ≥98% | Pass |
| ASTM F2299-03, Stand | |||
| test method for | |||
| determining the initial | Barrier Testing | ≥98% | Pass |
| efficiency of materials used | |||
| in medical face masks to | |||
| penetration by particulates | |||
| using latex spheres; | |||
| EN 14683: European | |||
| standard for face masks | Physical Testing |