← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K211696
# Disposable Surgical Face Mask (K211696)
_Anhui Cleanpro Pharmpack Co., Ltd. · FXX · Nov 30, 2021 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211696
## Device Facts
- **Applicant:** Anhui Cleanpro Pharmpack Co., Ltd.
- **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md)
- **Decision Date:** Nov 30, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Intended Use
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.
## Device Story
Disposable surgical face mask; flat-pleated, three-layer design. Outer/inner layers: spun-bond polypropylene; middle layer: melt-blown polypropylene filter. Features malleable aluminum nose piece for fit; available in tie-on or elastic ear-loop configurations. Used in clinical settings for infection control; protects wearer and patient from fluid/particulate transfer. Single-use, non-sterile device.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM F2299 (particulate filtration ≥99%), ASTM F1862 (fluid resistance at 160 mmHg), ASTM F2101 (bacterial filtration ≥99%), differential pressure (breathability <6.0 mmH2O/cm²), and 16 CFR 1610 (flammability Class 1). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).
## Technological Characteristics
Three-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter). Malleable aluminum nose piece. Tie-on or polyester elastic ear loops. Non-sterile. ASTM F2100 Level 3 performance. No electronic components or software.
## 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
- Surgical Face Mask ([K133070](/device/K133070.md))
## Submission Summary (Full Text)
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November 30, 2021
Anhui Cleanpro Pharmpack Co., Ltd. Chong Xiuming , Regulatory Manager Yeshan Industrial Zone Tianchang, Anhui 239300 CHINA
Re: K211696
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 20, 2021 Received: October 25, 2021
Dear Chong Xiuming:
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 avare 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K211696
Device Name Disposable Surgical Face Mask
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.
| 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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#### 510(K) Summary
#### This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92
#### Date prepared: October 20.2021
#### 1. Submitter Name and Address:
| Owner Name: | Anhui Cleanpro Pharmpack Co., Ltd. |
|-------------------------------------|-------------------------------------------------------|
| Establishment Registration Number : | 3016771217 |
| Address: | Yeshan Industrial Zone, Tianchang City, Anhui, China. |
| Post Code: | 239300 |
| Contactor Name: | Chong Xiuming |
| TEL: | +86-550-7981778 |
| E-mail: | carlchong@126.com |
#### Manufacturer Name: Anhui Cleanpro Pharmpack Co., Ltd.
| Address: | Yeshan Industrial Zone, Tianchang City, Anhui, China. |
|------------|-------------------------------------------------------|
| Post Code: | 239300 |
#### US Agent:
| US Agent: | LI QIAN |
|-----------|-----------------------------------------------------------|
| Address: | 4319 Abbotts Bridge Rd STE 3 Duluth Duluth, GA US 30097 |
| TEL: | 404 4261248 Ext |
| Email : | Li@Carelifeusa.Com |
#### 2. Submission Devices Information:
Trade/Proprietary Name: Disposable Surgical Face Mask Common Name: Disposable Surgical Face Mask Classification name: Surgical Apparel. Class: II. Product codes: FXX Submission Type: 510(K) Regulation Number: 21 CFR 878.4040
#### 3. Predicate Devices Information:
Company Name: BH Medical Products Co., Ltd. Address: No.90 Zhangjia Industrial Area, Xiling, Changzhou, Jiangsu, China 213024 Trade Name: Surgical Face Mask Class: II.
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Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
510(K) Number: K133070 Product codes: FXX Submission Type: 510(K) Regulation Number: 21 CFR 878.4040
### 4.Devices Description:
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose.
The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8.
The proposed device(s) are manufactured with three layers. the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of 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 device.
### 5. Indications for use:
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 nonsterile.
### 6. Comparison of technological characteristics with the predicate:
The primary components of The Disposable Surgical Face Masks are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicate devices.
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### Anhui Cleanpro Pharmpack Co., Ltd. Yeshan Industrial Zone, Tianchang City, Anhui Provice, China. [Disposable Surgical Face Mask]
### Table 1 General Comparison
| Element of Comparison | Submission Device | Predicate Device
K133070 | Comparison | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------|
| Manufacturer | Anhui Cleanpro
Pharmpack Co., Ltd. | BH Medical Products
Co., Ltd. | / | |
| 510 (k) | K211696 | K133070 | / | |
| Proprietary or Model Name | Surgical Face Mask, Ear
Loops, Model:CRWKE001
Surgical Face Mask, Tie-on,
Model:CRWKT001 | Surgical Face Mask, Ear
Loops, Model 101B, 101G,
136B, 136G, 137B, 137G
Surgical Face Mask, Tie-on,
Model 145B, 145G, 143B,
143G,
138B, 138G, 142B, 142G,
151B, 151G. | Similar | |
| Classification | Class II Device, FXX
(21CFR878.4040) | Class II Device, FXX
(21CFR878.4040) | Same | |
| Intended use/Indications for
Use | 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. | 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 | |
| Ear loop model and
Tie-on model | Ear Loops, Tie-On | Ear Loops, Tie-On | Same | |
| Mask styles | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same | |
| Materials | Outer Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle Layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| | Inner Facing Layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose Piece | Malleable aluminum wire | Malleable aluminum wire | Same |
| | Ear Loops | Polyester | Polyester | Same |
| Design features | | Color : Blue | Color : Blue, Green | Similar |
| Dimension (Length) | | 17.5 cm +/- 0.5cm | 6.8"+/-0.25" | Similar |
| Dimension (Width) | | 9.5 cm +/- 0.5cm | 3.5"+/-0.25"
4.2"+/-0.25" | Similar |
| OTC use | | Yes | Yes | Same |
| Single Use | | Yes | Yes | Same |
| Sterile | | No | No | Same |
| ASTM F2100 Level | | Level 3 | Level 1、Level 2、 Level 3 | Similar |
| Element of
Comparison | Submission Device | Predicate Device
K133070 | ASTM F2100
Requirements
for Level 3
Classification | Comparison |
| Fluid Resistance
Performance
ASTM F1862 | 1、LOT NO.: CR202101
1~32,32 out of 32 pass at
160 mmHg
2、LOT NO.: CR202102
33~64,32 out of 32 pass at
160 mmHg
3、LOT NO.: CR202103
65~96,32 out of 32 pass at
160 mmHg | Pass | 29 out of 32 pass
at
160 mmHg | Same |
| Particulate
Filtration
Efficiency ASTM
F2299 | 1、LOT NO.: CR202101
1~32: ≥ 99%
2、LOT NO.: CR202102
33~64: ≥ 99%
3、LOT NO.: CR202103
65~96: ≥ 99% | ≥ 98% | ≥ 98% | Same |
| Bacterial Filtration
Efficiency ASTM
F2101 | 1、LOT NO.: CR202101
1~32: ≥ 99%
2、LOT NO.: CR202102
33~64: ≥ 99%
3、LOT NO.: CR202103
65~96: ≥ 99% | ≥98% | ≥98% | Same |
| Differential
Pressure (DeltaP)
MIL-M-36954C | 1、LOT NO.: CR202101
1~32: <6.0 mmH2O/cm²
2、LOT NO.: CR202102
33~64: <6.0 mmH2O/cm²
3、LOT NO.: CR202103
65~96: <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Same |
| Flammability
16 CFR 1610 | 1、LOT NO.: CR202101
1~32: IBE
2、LOT NO.: CR202102
33~64: IBE
3、LOT NO.: CR202103
65~96: IBE | Class 1
Non Flammable | Class 1
(Burn time
≥3.5 seconds.
IBE, or DNI) | Same |
| Element of Comparison | Submission Device | Predicate Device
K133070 | Comparison | |
| Cytotoxicity | Under the conditions of the
study, not cytotoxicity
effect (Comply with ISO
10993-5) | Under the conditions of
the study, not
cytotoxicity effect
(Comply with ISO
10993-5 ) | Same | |
| Irritation | Under the conditions of the
study, not an Irritant
(Comply with ISO 10993-
10) | Under the conditions of
the study, not an Irritant
(Comply with ISO
10993-10 ) | Same | |
| Sensitization | Under conditions of the
study, not a sensitizer.
(Comply with ISO 10993-
10) | Under conditions of the
study, not a sensitizer.
(Comply with ISO
10993-10 ) | Same | |
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# Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
{7}------------------------------------------------
Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
#### Table 2 Performance Characteristic Comparison
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# Anhui Cleanpro Pharmpack Co., Ltd. Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
# Table 3 Biocompatibility Comparison
# 7.Summary non-Clinical Test:
### Discussion of Non-Clinical Tests Performed:
The performance tests of surgical face masks were conducted.
| Test Methodology | Test Methodology
Purpose | Acceptance Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------|
| ASTM F2299-03 Standard
Test Method for
Determining the Initial
Efficiency of Materials Used
in Medical Face Masks to
Penetration by Particulates
Using Latex Spheres | To evaluate the
effectiveness of the
test article in protecting
the user from possible
exposure to body
fluids. | ≥98% | Passed |
| 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) | To evaluate the
effectiveness of the
test article in protecting
the user from possible
exposure to
particulates. | Level 3, No
penetration at
160mmHg | Passed |
| ASTM F2101-19 Standard
Test Method For Evaluating
The Bacterial Filtration
Efficiency (Bfe) Of Medical | To evaluate the
bacterial filtration
efficiency (BFE) of
mask. | ≥98% | Passed |
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### Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
| Face Mask Materials, Using
A Biological Aerosol Of
Staphylococcus Aureus.
(General Plastic
Surgery/General Hospital) | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| MIL-M-36954C Military
Specification - Mask,
Surgical, Disposable 16
CFR Part 1610 STANDARD
FOR THE FLAMMABILITY
OF CLOTHING TEXTILES | To evaluate the
flammability of mask. | Class 1, Resist
ignition or flame
( Burn time ≥3.5
seconds, IBE, or
DNI ) | Passed |
| Differential Pressure (Delta
P) EN14683:2019, Annex C
and ASTM F2100-19 | To measure the
differential pressure
of mask which is
related to
breathability. | <6.0 mmH20/cm² | Passed |
| ISO 10993-5: 2009,
Biological Evaluation Of
Medical Devices -- Part 5:
Tests For In Vitro
Cytotoxicity.
(Biocompatibility) | To evaluate the
biological safety of
the product which has
direct contact with
intact skin. | The test article should
not have potential
toxicity to L-929 in the
MTT method. | Passed |
| ISO 10993-10: 2010,
Biological Evaluation Of
Medical Devices-Part 10:
Tests For Irritation And Skin
Sensitization.
(Biocompatibility) | To evaluate the
biological safety of
the product which has
direct contact with
intact skin. | The test article should
not cause delayed
dermal contact
sensitization in the
guinea pig.
The dermal irritation
response category in
the rabbit should be
negligible. | Passed |
### Discussion of Clinical Tests Performed: None
### 8. Conclusion:
Based on the comparison and analysis above, the Anhui Cleanpro Pharmpack Co., Ltd. Disposable Surgical Face Mask is as safe, as effective, and performs as well as the legally marketed predicate device, BH Medical Products Co., Ltd. Surgical Face Mask cleared under K133070.
### END
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211696](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K211696)
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