(181 days)
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 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.
The provided document primarily details the substantial equivalence determination for a Disposable Surgical Face Mask (K211696) to a predicate device (K133070). The acceptance criteria and "study" mentioned in the document refer to a series of non-clinical performance and biocompatibility tests conducted on the proposed device to demonstrate that it meets established standards for surgical masks, specifically ASTM F2100 Level 3 requirements.
Here's the breakdown of the information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology (Non-Clinical) | Acceptance Criteria | Reported Device Performance (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 (Particulate Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| 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) (Fluid Resistance Performance) | Level 3, No penetration at 160mmHg | Passed at 160 mmHg (for 3 lots) |
| 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. (Bacterial Filtration Efficiency) | ≥98% | ≥ 99% (Passed for 3 lots) |
| Differential Pressure (Delta P) EN14683:2019, Annex C and ASTM F2100-19 (Breathability) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² (Passed for 3 lots) |
| MIL-M-36954C Military Specification - Mask, Surgical, Disposable 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES (Flammability) | Class 1, (Burn time ≥3.5 seconds, IBE, or DNI) | IBE (Passed for 3 lots) |
| ISO 10993-5: 2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility - Cytotoxicity) | Not cytotoxicity effect to L-929 in the MTT method | Not cytotoxicity effect (Passed) |
| ISO 10993-10: 2010, Biological Evaluation Of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility - Irritation) | Negligible dermal irritation in rabbit | Not an Irritant (Passed) |
| ISO 10993-10: 2010, Biological Evaluation Of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility - Sensitization) | Not cause delayed dermal contact sensitization in guinea pig | Not a sensitizer (Passed) |
2. Sample Size Used for the Test Set and Data Provenance:
- For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The document mentions testing across 3 product lots (LOT NO.: CR202101, CR202102, CR202103). For each lot, 32 samples were tested for Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability.
- For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The document does not specify a numerical sample size but states "Under the conditions of the study" for each. However, these are standard biological evaluation tests that would have followed specific sample size requirements outlined in the referenced ISO standards.
- Data Provenance: The device is manufactured by Anhui Cleanpro Pharmpack Co., Ltd. in Tianchang, Anhui, China. The testing was conducted as part of their submission to the FDA. The tests are non-clinical (laboratory-based) and are likely retrospective in the context of this 510(k) submission, as they were performed to demonstrate compliance of an already manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to this submission. The "ground truth" here is defined by established international and national standards (ASTM, MIL-M, ISO) for medical device performance and biocompatibility. The tests are objective measurements against these predefined criteria, not subjective expert interpretations of clinical images or findings. Therefore, no "experts" for establishing ground truth in the traditional sense of clinical studies (e.g., radiologists) were involved.
4. Adjudication Method for the Test Set:
This is not applicable. The tests performed are objective, quantitative measurements against specified thresholds, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This is not applicable. This submission is for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. This submission is for a physical medical device.
7. The Type of Ground Truth Used:
The "ground truth" is based on established standard specifications and thresholds for surgical face masks as defined by:
- ASTM F2299-03
- ASTM F1862-17
- ASTM F2101-19
- MIL-M-36954C / 16 CFR 1610
- EN14683:2019
- ISO 10993-5: 2009
- ISO 10993-10: 2010
These standards define the acceptable performance limits for fluid resistance, filtration efficiency, breathability, flammability, and biocompatibility.
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical device like a surgical mask based on non-clinical performance and biocompatibility testing. This concept applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reason stated above.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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 DeviceK133070 | Comparison | |
|---|---|---|---|---|
| Manufacturer | Anhui CleanproPharmpack Co., Ltd. | BH Medical ProductsCo., Ltd. | / | |
| 510 (k) | K211696 | K133070 | / | |
| Proprietary or Model Name | Surgical Face Mask, EarLoops, Model:CRWKE001Surgical Face Mask, Tie-on,Model:CRWKT001 | Surgical Face Mask, EarLoops, Model 101B, 101G,136B, 136G, 137B, 137GSurgical 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 forUse | The Disposable Surgical FaceMasks are intended to beworn to protect both thepatient and healthcarepersonnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile. | The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | Same | |
| Ear loop model andTie-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 polypropylenefilter | Melt blown polypropylenefilter | 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 ofComparison | Submission Device | Predicate DeviceK133070 | ASTM F2100Requirementsfor Level 3Classification | Comparison |
| Fluid ResistancePerformanceASTM F1862 | 1、LOT NO.: CR2021011 | Pass | 29 out of 32 passat160 mmHg | Same |
| ParticulateFiltrationEfficiency ASTMF2299 | 1、LOT NO.: CR2021011 | ≥ 98% | ≥ 98% | Same |
| Bacterial FiltrationEfficiency ASTMF2101 | 1、LOT NO.: CR2021011 | ≥98% | ≥98% | Same |
| DifferentialPressure (DeltaP)MIL-M-36954C | 1、LOT NO.: CR2021011 | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Same |
| Flammability16 CFR 1610 | 1、LOT NO.: CR2021011 | Class 1Non Flammable | Class 1(Burn time≥3.5 seconds.IBE, or DNI) | Same |
| Element of Comparison | Submission Device | Predicate DeviceK133070 | Comparison | |
| Cytotoxicity | Under the conditions of thestudy, not cytotoxicityeffect (Comply with ISO10993-5) | Under the conditions ofthe study, notcytotoxicity effect(Comply with ISO10993-5 ) | Same | |
| Irritation | Under the conditions of thestudy, not an Irritant(Comply with ISO 10993-10) | Under the conditions ofthe study, not an Irritant(Comply with ISO10993-10 ) | Same | |
| Sensitization | Under conditions of thestudy, not a sensitizer.(Comply with ISO 10993-10) | Under conditions of thestudy, not a sensitizer.(Comply with ISO10993-10 ) | 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 MethodologyPurpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F2299-03 StandardTest Method forDetermining the InitialEfficiency of Materials Usedin Medical Face Masks toPenetration by ParticulatesUsing Latex Spheres | To evaluate theeffectiveness of thetest article in protectingthe user from possibleexposure to bodyfluids. | ≥98% | Passed |
| ASTM F1862-17 StandardTest Method ForResistance Of Medical FaceMasks To Penetration BySynthetic Blood (HorizontalProjection Of Fixed VolumeAt A Known Velocity) | To evaluate theeffectiveness of thetest article in protectingthe user from possibleexposure toparticulates. | Level 3, Nopenetration at160mmHg | Passed |
| ASTM F2101-19 StandardTest Method For EvaluatingThe Bacterial FiltrationEfficiency (Bfe) Of Medical | To evaluate thebacterial filtrationefficiency (BFE) ofmask. | ≥98% | Passed |
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Yeshan Industrial Zone, Tianchang City, Anhui Provice, China.
[Disposable Surgical Face Mask]
| Face Mask Materials, UsingA Biological Aerosol OfStaphylococcus Aureus.(General PlasticSurgery/General Hospital) | |||
|---|---|---|---|
| MIL-M-36954C MilitarySpecification - Mask,Surgical, Disposable 16CFR Part 1610 STANDARDFOR THE FLAMMABILITYOF CLOTHING TEXTILES | To evaluate theflammability of mask. | Class 1, Resistignition or flame( Burn time ≥3.5seconds, IBE, orDNI ) | Passed |
| Differential Pressure (DeltaP) EN14683:2019, Annex Cand ASTM F2100-19 | To measure thedifferential pressureof mask which isrelated tobreathability. | <6.0 mmH20/cm² | Passed |
| ISO 10993-5: 2009,Biological Evaluation OfMedical Devices -- Part 5:Tests For In VitroCytotoxicity.(Biocompatibility) | To evaluate thebiological safety ofthe product which hasdirect contact withintact skin. | The test article shouldnot have potentialtoxicity to L-929 in theMTT method. | Passed |
| ISO 10993-10: 2010,Biological Evaluation OfMedical Devices-Part 10:Tests For Irritation And SkinSensitization.(Biocompatibility) | To evaluate thebiological safety ofthe product which hasdirect contact withintact skin. | The test article shouldnot cause delayeddermal contactsensitization in theguinea pig.The dermal irritationresponse category inthe rabbit should benegligible. | 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
§ 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.