(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
A therapeutic device is used to treat or prevent a disease or condition, whereas this device is a surgical mask intended to protect from transfer of microorganisms and body fluids.
No
Explanation: The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (polypropylene layers, ear loops, nose piece) and performance testing related to material properties and physical barriers, indicating it is a hardware device.
Based on the provided information, 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. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask. There are no components or mechanisms described that would be used for testing samples or diagnosing conditions.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration efficiency, resistance to penetration) and biocompatibility. These are relevant to a protective device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical mask does not fit that description.
N/A
Intended Use / Indications for Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
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)
Performance Testing Summary:
- Test item: Bacterial filtration efficiency, Test method: ASTM F2101-19, Pass criteria (Level 1): >= 95%, Pass criteria (Level 3): >= 98%, Test results/Verdict: Pass
- Test item: Differential pressure (Delta-P), Test method: EN 14683: 2019, Annex C, Pass criteria (Level 1): = 95%, Pass criteria (Level 3): >= 98%, Test results/Verdict: Pass
- Test item: Resistance to penetration by synthetic blood, minimum pressure in mmHg for pass result, Test method: ASTM F1862/F1862M-17, Pass criteria (Level 1): Pass at 80 mm Hg, Pass criteria (Level 3): Pass at 160 mm Hg, Test results/Verdict: Pass
- Test item: Flame spread, Test method: 16 CFR Part 1610, Pass criteria (Level 1): Class 1, Pass criteria (Level 3): Class 1, Test results/Verdict: Pass
Biocompatibility Testing Summary:
- Test: In vitro Cytotoxicity Test, Purpose: determine whether the target device extract is cytotoxic, Reference: ISO 10993-5:2009, Acceptance criteria: non-cytotoxic, Test results: Pass
- Test: Skin Sensitization Test, Purpose: determine whether the non-polar and polar extracts of the target device are sensitive, Reference: ISO 10993-10:2010, Acceptance criteria: non-sensitizing, Test results: Pass
- Test: Skin Irritation Test, Purpose: determine whether the non-polar and polar extracts of the target device are irritating, Reference: ISO 10993-10:2010, Acceptance criteria: non-irritating, Test results: Pass
No clinical study is included in this submission.
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
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 FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
July 6, 2022
Jiangxi SanHao Medical Instruments Co., Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K221173
Trade/Device Name: Surgical Mask (Model: 0868F, 0866F) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 14, 2022 Received: April 25, 2022
Dear Ms. 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.
1
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 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
2
Indications for Use
510(k) Number (if known) K221173
Device Name Surgical Mask (Model: 0868F, 0866F)
Indications for Use (Describe)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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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3
510(k) Summary
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: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wangfenfang (General Manager) Tel: +86 0796-3256750 Phone: +86-151 7966 0192 E-mail: 1218060588@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com
Date of the summary prepared: July 1, 2022
2. Subject Device Information
Common Name: Surgical Mask Classification Name: Mask, Surgical Trade Name: Surgical Mask Model Name: 0868F, 0866F Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: Class II
3. Predicate Device Information
Predicate Device 1 (Primary predicate device): Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd. Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
4
Classification Name: Mask, Surgical 510(k) Number: K212293 Review Panel: General Hospital Product Code: FXX Requlation Number: 21 CFR 878.4040 Requlation Class: II
Predicate Device 2 (Additional predicate device):
Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask Classification Name: Mask, Surgical 510(k) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
4. Device Description
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.
5. Intended Use / Indications for Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Surgical Mask is 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.
Comparison to predicate device and conclusion 6.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Elements of
Comparison | Subject Device | Predicate Device 1 (Primary
predicate device) | Predicate
Device 2
(Additional
predicate
device) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Jiangxi SanHao
Medical
Instruments Co.,Ltd | Jiangmen Ningrui Medical
Supplies Co., Ltd. | Shandong
Shengquan
New Materials
Co., Ltd. | -- |
| 510 (k) | K221173 | K212293 | K211552 | -- |
| Trade Name | Surgical Mask | Surgical Mask | Surgical mask | -- |
| Model | 0868F, 0866F | WK1701-02A, WK1701-03A,
WK1701-04A | SMDP20608 | -- |
| Classification
Name | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| Product
Code | FXX | FXX | FXX | Same |
| Intended use | The Surgical Mask
is intended to be
worn to protect
both the patient
and healthcare
personnel from
transfer of
microorganisms,
body fluids, and
particulate material.
The Surgical Mask
is intended for use
in infection control
practices to reduce
the potential
exposure to blood
and body fluids.
This is a single- | The Surgical Mask is intended
to be worn to protect both the
patient and healthcare
personnel from the transfer of
microorganisms, body fluids,
and particulate material. The
Surgical Mask is 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
masks are
intended to be
worn to protect
both the patient
and healthcare
personnel from
transfer of
microorganisms,
body fluids and
particulate
material. These
surgical masks
are intended for
use in infection
control practices
to reduce the
potential | Same |
| Elements of
Comparison | Subject Device | Predicate Device 1 (Primary
predicate device) | Predicate
Device 2
(Reference
predicate
device) | Remark |
| | use, disposable
device, provided
non-sterile. | | exposure to
blood and body
fluids. This is a
single use,
disposable
device, and
provided non-
sterile. | |
| Materials | | | | |
| Outer facing
layer | Polypropylene
spunbond | Polypropylene spunbond
fabric | Polypropylene
Spunbond | Same |
| Middle filter
layer | Melt blown
polypropylene | Polypropylene spunbond
fabric | Melt blown
polypropylene
filter | Same |
| Inner facing
layer | Polypropylene
spunbond | Polypropylene spunbond
fabric | Polypropylene
Spunbond | Same |
| Nose piece | Polyethylene
coated iron wire | Polypropylene coated
galvanized iron wire | Malleable
polyethylene | Similar
Note 1 |
| Ear loops | Spandex | Nylon, spandex | Spandex,
Polyester | Similar
Note 1 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| Color | Blue (0866F),
Black (0868F) | Bule | Black and White | Similar
Note 1 |
| Dimensions | 175mm x 95mm
(±5mm)
Ear loop: 175mm
Nose piece: 80 ±
2mm | Length: 17.5 cm ±5mm
Width: 9.5 cm±3mm | Length:
17.5cm±0.88cm
Width:
9.5cm±0.48cm | Same
Note 1 |
| | OTC use | Yes | Yes | Yes |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single-use | Yes | Yes | Yes | Same |
6
7
| Elements of
Comparison | Subject Device | Predicate Device 1 (Primary
predicate device) | Predicate Device 2
(Reference predicate
device) | Remark | | | |
|------------------------------------------------------------|----------------------------------|--------------------------------------------------|-------------------------------------------------------|-----------------------------|-------------------------------|-----------------------------------------------|-------------------|
| Performance
Testing | Level 1
(0868F) | Level 3
(0866F) | Level 1 | Level 2 | Level 3 | Level 3 | Same |
| Fluid
Resistance
Performance
(ASTM
F1862) | Pass at
80 mmHg | Pass at
160 mmHg | Pass at
80 mm Hg | Pass at
120 mm Hg | Pass at
160 mm Hg | Passed at 29
out of 32 pass
at 160 mmHg | Same |
| Particulate
Filtration
Efficiency
(ASTM
F1215) | Pass at
$\ge$ 95% | Pass at
$\ge$ 98% | Pass at
$\ge$ 99% | Pass at $\ge$
99% | Pass at
$\ge$ 99% | $\ge$ 98% | Similar
Note 2 |
| Bacterial
Filtration
Efficiency
(ASTM
F2101) | Pass at
$\ge$ 95% | Pass at
$\ge$ 98% | Pass at
$\ge$ 99% | Pass at $\ge$
99% | Pass at
$\ge$ 99% | $\ge$ 98% | Similar
Note 2 |
| Differential
Pressure
(ASTM
F2100) | Pass at
$