← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K201691
# Single-Use Surgical Mask With Ear Loop (K201691)
_Qiqihar Hengxin Medical Supplies, Ltd. · FXX · Sep 17, 2020 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201691
## Device Facts
- **Applicant:** Qiqihar Hengxin Medical Supplies, Ltd.
- **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md)
- **Decision Date:** Sep 17, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Intended Use
The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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.
## Device Story
Single-use, disposable surgical face mask; flat-pleated design; three-layer construction (inner/outer layers: PP spun-bond non-woven fabric; middle layer: melt-blown non-woven fabric). Features malleable aluminum nose piece for fit and polyester elastic ear loops for securement. Used in clinical settings by healthcare personnel and patients to provide barrier protection against blood, body fluids, and microorganisms. Device is non-sterile; provides Level 2 barrier protection per ASTM F2100. Clinical benefit derived from physical filtration of particulates and fluid resistance, reducing cross-contamination risk.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration >99%), ASTM F2101 (bacterial filtration >99%), MIL-M-36954C (differential pressure <5.0 mmH2O/cm²), and 16 CFR 1610 (flammability Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
## Technological Characteristics
Three-layer non-woven construction: PP spun-bond outer/inner layers, melt-blown polypropylene middle filter layer. Malleable aluminum nose wire. Polyester elastic ear loops. Dimensions: Model M (14x9cm), Model L (18x9cm). ASTM F2100 Level 2 barrier performance. Non-sterile, single-use, disposable.
## 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
- Disposable Surgical Face Mask ([K153496](/device/K153496.md))
## Submission Summary (Full Text)
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September 17, 2020
Qiqihar Hengxin Medical Supplies, Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K201691
Trade/Device Name: Single-Use Surgical Mask With Ear Loop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 18, 2020 Received: August 21, 2020
Dear Ray 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.
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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 (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 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 CAPT Elizabeth Claverie, M.S. 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
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## Indications for Use
510(k) Number (if known) K201691
Device Name Single-Use Surgical Mask with Ear Loop
#### Indications for Use (Describe)
The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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.
Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.
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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# K201691
## 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
- 1. Date of Preparation: 2020/09/17
- 2. Sponsor Identification
### Qiqihar Hengxin Medical Supplies, Ltd.
10th Beijiang Road in Tiefeng Industrial Park, North Shuguang Ave. Tiefeng District, Qiqihar, Heilongjiang Province, China, 161000
Contact Person: Sihui Xiong Position: Commercial Manager Tel: +86-452-5656959 Email: 476923513@qq.com
- 3. Designated Submission Correspondent
Mr. Ray Wang
### Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang(@believe-med.com
- 4. Identification of Proposed Device
Trade Name: Single-Use Surgical Mask with Ear Loop Common Name: Surgical Face Mask Model(s): M, L;
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Regulatory Information Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
### Indication for use Statement:
The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 nonsterile. Model: M and L, blue color, Level 2 barrier level as ASTM F2100.
### Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is bule masterbatch.
The Single-Use Surgical Mask with Ear Loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask.
The elastic ear loops are made with Polyester.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The only difference is the dimension.
#### Identification of Predicate Device(s) న్.
Predicate Device K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Itd.
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#### Substantially Equivalent (SE) Comparison 6.
| ITEM | Proposed Device K201691 | Predicate Device K153496 | Remark | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------|
| Intended Use | The Single-Use Surgical Mask with Ear
Loop is intended to be worn to protect both
the patient and healthcare personnel from
the transfer of microorganisms, body fluids,
and particulate material. The Single-Use
Surgical Mask with Ear Loop 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 Disposable 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 | |
| Basic Design | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | SAME | |
| Materials | Outer Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | SAME |
| | Middle Layer | Melt blown non-woven fabric | Melt blown polypropylene filter | |
| | Inner Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | |
| | Nose Piece | Malleable aluminum wire | Malleable aluminum wire | |
| | Ear Loops | Polyester | Polyester | |
| Color | Blue | Blue | SAME | |
| Dimension (Length) | Model M: 14 cm +/- 1cm
Model L: 18 cm +/- 1cm | 17.5 cm +/- 1cm | SIMILAR | |
| Dimension (Width) | 9 cm +/- 1cm | 9.5 cm +/- 1cm | | |
| OTC use | Yes | Yes | SAME | |
| Single Use | Yes | Yes | SAME | |
| Sterile | No | No | SAME | |
| ASTM F2100 Level | Level 2 | Level 2 | SAME | |
Table 2 General Comparison
Table 3 Performance Characteristic Comparison
| ITEM | Proposed
Device
K201691 | Predicate Device
K153496 | ASTM F2100
Requirements for
Level 2 Classification | Remark |
|----------------------------------------------------|-------------------------------|-------------------------------|----------------------------------------------------------|---------|
| Fluid Resistance
Performance ASTM
F1862 | 31 out of 32 pass at 120 mmHg | 31 out of 32 pass at 120 mmHg | 29 out of 32 pass at 120 mmHg | SIMILAR |
| Particulate Filtration
Efficiency ASTM
F2299 | >99% | 98.46% | $\geq$ 98% | |
| Bacterial Filtration
Efficiency ASTM | >99% | 98.7% | $\geq$ 98% | |
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| F2101 | | | | |
|-----------------------------------------------------|-----------------|---------------|-----------------|------|
| Differential Pressure
(Delta P) MIL-M-
36954C | < 5.0 mmH2O/cm² | 4.2 mmH2O/cm² | < 6.0 mmH2O/cm² | |
| Flammability
16 CFR 1610 | Class 1 | Class 1 | Class 1 | SAME |
## Table 4 Biocompatibility Comparison
| ITEM | Proposed Device K201691 | Predicate Device K153496 | Remark |
|---------------|--------------------------------------------------------------|--------------------------|--------|
| Cytotoxicity | Under the conditions of the study, no
cytotoxicity effect | Comply with ISO 10993-5 | SAME |
| Irritation | Under the conditions of the study, no
irritation effect | Comply with ISO 10993-10 | SAME |
| Sensitization | Under conditions of the study, no
sensitization effect | | SAME |
#### 7. Summary of Non-Clinical Testing
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
| Name of the Test
Methodology/standard | Purpose | Acceptance Criteria | Results |
|------------------------------------------|------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| ASTM F1862 | Resistance to penetration
by synthetic blood | 120 mm Hg | 120 mm Hg |
| ASTM F2299 | Sub-micron particulate
filtration efficiency at 0.1
micron | ≥ 98% | >99% |
| ASTM F2101 | Bacterial Filtration
Efficiency | ≥ 98% | >99% |
| MIL-M-36954C | Differential Pressure | < 6.0 mm H2O/cm² | < 5.0 mm H2O/cm² |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ISO 10993-5 | Irritation | No irritation effect | Under the conditions
of the study, no
irritation effect |
| | Sensitization | No sensitization
effect | Under conditions of
the study, no
sensitization effect |
| ISO 10993-10 | Cytotoxicity | No cytotoxicity effect | Under the conditions
of the study, no
cytotoxicity effect |
Table 1 Non-Clinical Testing
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#### 8. Summary of Clinical Testing
No clinical study is included in this submission.
#### 9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Single-Use Surgical Mask with Ear Loop, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Face Mask (K153496).
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201691](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201691)
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