← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K210524
# Surgical Mask (K210524)
_Changzhou Holymed Products Co., Ltd. · FXX · Jul 7, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210524
## Device Facts
- **Applicant:** Changzhou Holymed Products Co., Ltd.
- **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md)
- **Decision Date:** Jul 7, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## 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-use, disposable device, provided non-sterile.
## Device Story
Three-layer flat-pleated surgical mask; nonwoven polypropylene construction. Outer/inner layers: spunbonded polypropylene; middle layer: melt-blown polypropylene. Malleable polyethylene-laminated aluminum nosepiece; knitted polyester/elastane ear-loops. Single-use, disposable, non-sterile. Worn by healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulates. Provides infection control in clinical settings.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration efficiency >99.9%), ASTM F2101-19 (bacterial filtration efficiency ≥99.9%), and 16 CFR 1610 (flammability Class 1). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation and sensitization).
## Technological Characteristics
Three-layer nonwoven polypropylene (spunbonded/melt-blown/spunbonded). Malleable polyethylene-laminated aluminum nosepiece. Knitted polyester/elastane ear-loops. Flat-pleated form factor. Non-sterile. ASTM F2100 Level 3 compliant. No software or electronic components.
## 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
- Level 3 Surgical Face Masks by San-M Package Co., Ltd. ([K160269](/device/K160269.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2021
Changzhou Holymed Products Co., Ltd. Shan Shang Regulatory Correspondent 525 Changwu Road South Changzhou, Jiangsu 213167 China
Re: K210524
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 15, 2021 Received: April 20, 2021
Dear Shan Shang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
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 Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
K210524
Device Name
Surgical Mask
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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Image /page/3/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue plus sign made up of rounded squares. The company name is in all caps and in a dark gray color.
#### 510(k) Summary
# 510(k) Summary
Pursuant to 21 CFR 807.92
Prepared on April 14, 2021
#### 1. Submitter
| Manufacturer Name and Address: | Changzhou Holymed Products Co., Ltd.
525 Changwu Road South
Wujin District, Changzhou
Jiangsu, China 213167 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Shan Shang |
| Telephone Number: | +86 183 5120 0602 |
| Email Address: | shan.shang@gogii.ca |
2. Device Name
| Device Name: | Surgical Mask |
|--------------|---------------|
| Common Name: | Surgical Mask |
Regulatory Information:
| Classification Name: | Mask, Surgical |
|----------------------|-----------------|
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
#### 3. Predicate
K160269 Level 3 Surgical Face Masks by San-M Package Co., Ltd. Particularly, the following model:
| Model # | Style |
|---------|----------|
| EL30000 | Ear-loop |
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Image /page/4/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol that resembles a plus sign with rounded edges, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left side of the logo, and the word "HOLYMED" is on the right side.
#### 4. Device Description
The surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, provided non-sterile.
| Product # | Style | Color |
|-----------|----------|-------|
| HM-02-01 | Ear-loop | Blue |
#### 5. Intended Use/ Indication 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.
#### 6. Comparison to Predicate
#### (a) Technological Characteristics
Summarized in Table 1 below is the comparison of the technological characteristics between the proposed and the predicate devices.
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Image /page/5/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol on the left and the word "HOLYMED" in gray on the right. The symbol is a stylized cross made up of rounded squares and a circle in the center.
| Table 1 - Technological Characteristics Comparison | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Description | Proposed Device | Predicate Device | Comparison |
| 510(k) Number | K210524 | K160269 (EL30000) | N/A |
| Manufacturer | Changzhou Holymed Products
Co., Ltd. | San-M Package Co., Ltd. | N/A |
| Common Name | Surgical Mask | Surgical Mask | Identical |
| Classification | Class II | Class II | Identical |
| Product Code | FXX | FXX | Identical |
| 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-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
materials. 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. | Identical |
| Material Composition | | | |
| Outer Cover | Polypropylene spunbonded | Polypropylene | Similar |
| Middle Layer | Polypropylene melt-blown | 1. Polypropylene spunbond
2. Polypropylene meltblown | Similar |
| Inner Facing | Polypropylene spunbonded | Polypropylene | Similar |
| Nosepiece | Polyethylene laminated
aluminum | Polyethylene coated steel wire | Similar |
| Ear-loop | Knitted polyester/ elastane | Polyester, polyurethane. Side
tapes: Polyester spunbond
(ear loops mask only) | Similar |
| Colorant | Polypropylene masterbatch | Unknown | Similar |
| Dimensions | | | |
| Length | $95 \pm 3mm$ | $90 \pm 3 mm$ | Similar |
| Width | $175 \pm 3mm$ | $175 \pm 5 mm$ | Similar |
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Image /page/6/Picture/0 description: The image shows the logo for HOLYMED. The logo consists of a blue and white symbol resembling a stylized plus sign or a network of interconnected nodes, followed by the word "HOLYMED" in gray, block letters. The symbol is on the left, and the text is on the right.
| Design Features | Ear-loop | Ear-loop | Identical |
|-----------------|------------------------|------------------------|-----------|
| Color | Blue | White or blue | Similar |
| Mask Style | Flat-pleated | Flat-pleated | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Use Frequency | Single-use, disposable | Single use, disposable | Identical |
| ASTM 2100 Level | Level 3 | Level 3 | Identical |
#### (b) Performance
- (i) Clinical Test: Not applicable.
- (ii) Non-Clinical Test:
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the performance acceptance criteria and performed as effective as the predicate device.
Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology.
#### Table 2: Non-Clinical Performance Testing Table
| Test
Methodology | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance
ASTM F1862 | Determine the
ability of the
mask's material
to resist
penetration of
blood and body
fluids. | Pass/fail basis at any
of three velocities
corresponding to the
range of human blood
pressure
Level 1 – 80 mmHg
Level 2 – 120 mmHg
Level 3 - 160 mmHg | Level 3
Passed at 160 mmHg.
All 3 lots tested passed with no
synthetic blood penetration
observed at 160 mmHg, under
the conditions of the test. |
| Particulate
Filtration
Efficiency
ASTM F2299 | Determine the
ability of the
mask's material
to prevent
passage of
aerosolized
submicron
particulates. | Pass/fail basis
Level 1 – 95%
Level 2 – 98%
Level 3 – 98% | Level 3
Passed at > 99.9%
Average Filtration Efficiency:
AMSB-LOT202010007: >99.979%
AMSB-LOT202011002:
>99.9814%
AMSB-LOT202011005: >99.984% |
| Bacterial
Filtration
Efficiency
ASTM F2101-19
| Determine the
ability of the
mask's material
to prevent
passage of
aerosolized
bacteria.
Determine the
resistance of
the surgical
facemask to air
flowing through
the mask. | Pass/fail basis
Level 1 - 95%
Level 2 – 98%
Level 3 – 98%
Pass/fail basis
Level 1 – <5 mm
H2O/cm²
Level 2 – <6 mm
H2O/cm²
Level 3 – <6 mm
H2O/cm² | Level 3
Passed at ≥ 99.9%
All samples tested passed with a
filtration efficiency percentage of
at least 99.9%, under the
conditions of the test.
Level 1
Passed, < 5 mm H2O/cm².
AMSB-LOT202010007: ≤ 3.7 mm
H2O/cm2.
AMSB-LOT202011002: ≤ 3.7 mm
H2O/cm2.
AMSB-LOT202011005: ≤ 4.9 mm
H2O/cm2. |
| Flammability
16 CFR Part 1610 | Determine the
ability of the
mask to resist
ignition to an
externally
applied ignition
source. | Pass/fail basis
Class 1, normal
flammability specified
in 16 CFR Part 1610. | Passed at Class 1
All samples tested achieved a
Class 1 flammability rating under
the conditions of the test. |
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Image /page/7/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is written in gray, block letters.
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Image /page/8/Picture/0 description: The image shows the logo for HOLYMED. To the left of the company name is a blue and white symbol that resembles a plus sign. The company name is in all caps and in a dark gray color.
## (c) Safety
To address the safety risks from wearing of the surgical mask, biocompatibility tests were performed according to the standard ISO 10993 as referenced in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions posted on July 14, 2004. All samples met the test criteria and are as safe as the predicate device. Test results are summarized in Table 3 below.
| Table 3: Summary of Biocompatibility Test Result and Comparison | | | | | | | |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------|--|--|--|--|
| Test
Methodology | Purpose | Acceptance Criteria | Results | | | | |
| Cytotoxicity
ISO 10993-5 | Determine the biological
response of mammalian
cells in-vitro | Non-cytotoxic | Under the conditions of
the study, non-
cytotoxicity effect | | | | |
| Skin-irritation
ISO 10993-10 | Assess the potential of a
medical device and its
constituent materials to
produce skin irritation | Non-irritating | Under the conditions of
the study, non-irritation | | | | |
| Sensitization
ISO 10993-10 | Assess the potential of a
medical device and its
constituent materials to
produce host sensitization | Non- sensitizing | Under the conditions of
the study, non-
sensitization | | | | |
### (d) Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K210524, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
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