(54 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties and material composition of a medical mask, with no mention of AI or ML capabilities.
No.
The device is intended to protect against the transfer of microorganisms and fluids, which is a preventive measure rather than a treatment for a disease or condition.
No
This device is a medical protective mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its function is to act as a barrier, not to diagnose any condition or disease.
No
The device description clearly outlines physical components (polypropylene, polyester, wire) and performance testing relates to material properties and physical barriers, not software functionality.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of the mask and its materials. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, pressure resistance, and biocompatibility. These are not diagnostic performance metrics like sensitivity, specificity, or accuracy in detecting a specific analyte.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
This device is a medical protective mask, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
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)
Performance Testing summary:
- Test item: Bacterial filtration efficiency; Test method: 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 according to ASTM F2100: 2019; Pass criteria: Level 1: >= 95%, Level 2: >= 98%, Level 3: >= 98%; Test results/Verdict: Pass.
- Test item: Differential pressure (Delta-P); Test method: EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100: 2019; Pass criteria: Level 1: = 95%, Level 2: >= 98%, Level 3: >= 98%; Test results/Verdict: Pass.
- Test item: Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result; Test method: ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) according to ASTM F2100:2019; Pass criteria: Level 1: Pass at 80 mm Hg, Level 2: Pass at 120 mm Hg, Level 3: Pass at 160 mm Hg; Test results/Verdict: Pass.
- Test item: Flame spread; Test method: 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019; Pass criteria: Level 1: Class 1, Level 2: Class 1, Level 3: Class 1; Test results/Verdict: Pass.
Biocompatibility Testing:
- Test: In vitro Cytotoxicity Test; Purpose: Under the research conditions, determine whether the target device extract is cytotoxic.; Reference for Test method: ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity; Acceptance criteria: Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.; Test results: Pass.
- Test: Skin Sensitization Test; Purpose: Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive.; Reference for Test method: ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization; Acceptance criteria: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be nonsensitizing.; Test results: Pass.
- Test: Skin Irritation Test; Purpose: Under the research conditions, determine whether the non-polar and polar extracts of the target device are irritating.; Reference for Test method: ISO 10993-10:2010 Biological evaluation of medical devices - Part 23: Tests for irritation and skin sensitization; Acceptance criteria: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.; Test results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
November 23, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Guangdong Golden Leaves Technology Development Co., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 523000 China
Re: K223068
Trade/Device Name: Medical Protective Mask (model: 8862, 8862B, 8862C, 8862D, 8862E) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 28, 2022 Received: September 30, 2022
Dear Cassie Lee:
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,
Anne D. Talley -S
for
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
2
Indications for Use
510(k) Number (if known) K223068
Device Name
Medical Protective Mask (model: 8862, 8862A, 8862C, 8862C, 8862D, 8862E)
Indications for Use (Describe)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
For activities where HUD funding is NOT being directly obligated or expended
For activities where HUD funding IS being directly obligated or expended
| | 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 of K223068
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Guangdong Golden Leaves Technology Development Co., Ltd. Address: 5F, BLDG 2, #8, Qiaolonghe East Rd, Tangxia Town, Dongguan, Guangdong, 523730, China Post Code: 523730 Contact name: Wenhong Zhou Tel: +86-13416994806 E-mail: info@gdgoldenleaves.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
2. Date of the summary prepared: Jun 26, 2022
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: Medical Protective Mask Model Name: 8862, 8862A, 8862B, 8862C, 8862D, 8862E Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
4. Predicate Device Information
Predicate Device:
Sponsor: Jiangxi Hongda Medical Equipment Group Co., Ltd. Trade Name: Single-Use Medical Face Mask Classification Name: Mask, Surgical
4
510(K) Number: K210622 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
5. Device Description
The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
| Type
| Level | Ear Loop | Headband |
|---|---|---|
| Level 1 | 8862B | 8862E |
| Level 2 | 8862A | 8862D |
| Level 3 | 8862 | 8862C |
Both the ear loop and headband masks are available in level 1, level 2 and level 3:
All models are made of the same material and have identical performance, meeting the performance requirements of three levels at the same time.
The device is provided non-sterile.
6. Intended Use / Indications for Use
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Verdict |
|---|---|---|---|
| Company | Guangdong Golden Leaves | ||
| Technology Development Co., | Jiangxi Hongda Medical | ||
| Equipment Group Co., Ltd. | -- | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Verdict |
| Ltd. | |||
| 510 (k) | K223068 | K210622 | -- |
| Trade Name | Medical Protective Mask | Single-Use Medical Face Mask | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Same |
| Product Code | FXX | FXX | Same |
| Intended use | The Medical Protective Mask | ||
| is intended to be worn to | |||
| protect both the patient and | |||
| healthcare personnel from | |||
| transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. These 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, | |||
| provide non-sterile. | The single-use medical 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, | |||
| provided sterile and non-sterile. | Same | ||
| Mask style | Flat-folded | Flat-pleated | Same |
| Design feature | Ear loop, headband | Ear loop or tie-on | Similar |
| Note 1 | |||
| Color | Green | White | Different |
| Note 1 | |||
| Dimension | Mask body: 205x80mm | ||
| Nose clip: 100mm | |||
| Ear loop: 150mm | |||
| Headband: 350mm | Mask body: 175x95mm | ||
| Nose Clip: 80~105mm | |||
| Ear loop: 140~150mm | |||
| Ties: 330~400mm | Similar | ||
| Note 1 | |||
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Materials | |||
| Outer facing layer | Polypropylene Spunbonded | ||
| Nonwoven | Polypropylene Spunbonded | ||
| Nonwoven | Same | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Verdict |
| Filter layer | Polypropylene Melt-blown | ||
| Nonwoven | Polypropylene Melt-blown | ||
| Nonwoven | Same | ||
| Inner facing layer | Polypropylene Spunbonded | ||
| Nonwoven | Polypropylene Spunbonded | ||
| Nonwoven | Same | ||
| Nose Clip | Polypropylene and wire | Polypropylene and iron | Similar |
| Note 1 | |||
| Ear | |||
| loops/headband | Polyester | Polyester and spandex | Similar |
| Note 1 | |||
| Performance Characteristics | |||
| ASTM F2100 | |||
| Level | Level 1, Level 2, Level 3 | Level 1, Level 2, Level 3 | Same |
| Fluid resistance | Level 1: Pass at 80 mmHg | ||
| Level 2: Pass at 120 mmHg | |||
| Level 3: Pass at 160 mmHg | Level 1: Pass at 80 mmHg | ||
| Level 2: Pass at 120 mmHg | |||
| Level 3: Pass at 160 mmHg | Same | ||
| Particulate | |||
| filtration | |||
| efficiency | Level 1: ≥95% | ||
| Level 2: ≥98% | |||
| Level 3: ≥98% | Level 1: | ||
| Ear loop (Non-sterile): ≥95% | |||
| Level 2: | |||
| Ear loop (Non-sterile): ≥98% | |||
| Level 3: | |||
| Ear loop (Non-sterile): ≥98% | Same | ||
| Bacterial filtration | |||
| efficiency | Level 1: ≥95% | ||
| Level 2: ≥98% | |||
| Level 3: ≥98% | Level 1: | ||
| Ear loop (Non-sterile): ≥95% | |||
| Level 2: | |||
| Ear loop (Non-sterile): ≥98% | |||
| Level 3: | |||
| Ear loop (Non-sterile): ≥98% | Same | ||
| Differential | |||
| pressure | Level 1: 24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: |
| Title of the test | Purpose of the
test | Reference
for
Test method | Acceptance
criteria | Test
results |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| In vitro
Cytotoxicity Test | Under the research
conditions.
determine whether
the target device
extract is cytotoxic. | ISO 10993-5:2009
Biological evaluation
of medical devices-
Part 5: Tests for in
vitro cytotoxicity | Under the
conditions of the
study, the subject
device extract was
determined to be
non-cytotoxic. | Pass |
| Skin
Sensitization
Test | Under the research
conditions,
determine whether
the non-polar and
polar extracts of
the target device
are sensitive. | ISO 10993-10:2010
Biological evaluation
of medical devices-
Part 10: Tests for
irritation and skin
sensitization | Under the
conditions of the
study, the subject
device non-polar
and polar extracts
were determined to
be non-sensitizing. | Pass |
| Skin Irritation
Test | Under the research
conditions,
determine whether
the non-polar and
polar extracts of
the target device
are irritating. | ISO 10993-10:2010
Biological evaluation
of medical devices-
Part 23: Tests for
irritation and skin
sensitization | Under the
conditions of the
study, the subject
device non-polar
and polar extracts
were determined to
be non-irritating. | Pass |
9. Summary of Clinical Performance Test
10
No clinical study is included in this submission.
10. Final Conclusion
The subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210622.