(312 days)
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose. The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm. The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Surgical Mask (Model: Flat-type) (K202126):
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Level 1 ASTM F2100-19) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 95% | ≥ 95% |
| Differential Pressure (Delta-P) | < 5.0 mm H2O/cm² | < 5 mm H2O/cm² |
| Particulate Filtration Efficiency | ≥ 95% (at 0.1 µm) | ≥ 95% |
| Resistance to Synthetic Blood | Fluid resistant at 80 mmHg | 80 mmHg |
| Flammability | Class 1 | Class 1 |
| In vitro Cytotoxicity Test | Non-cytotoxic | Non-cytotoxic |
| Skin Sensitization Test | Non-sensitizing | Non-sensitizing |
| Skin Irritation Test | Non-irritating | Non-irritating |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states "32/32 Passed" for all performance tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Resistance to Synthetic Blood, and Flammability). This indicates a sample size of 32 units for each of these performance tests.
For biocompatibility tests (Cytotoxicity, Sensitization, Irritation), no specific number of samples is provided beyond the statement "Under the conditions of the study," which is typical for such assessments and does not usually involve a large numerical sample count for establishing non-toxicity/irritation/sensitization.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that these are laboratory performance tests conducted by the manufacturer for regulatory submission, they are almost certainly prospective tests performed on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and therefore not provided in the document. The "ground truth" for device performance in this context is established through objective, standardized laboratory tests (e.g., ASTM F2101-14 for BFE, ASTM F2299-03 for PFE, ASTM F1862/F1862M-17 for fluid resistance). These tests have defined methodologies and pass/fail criteria, and their results are quantitative or qualitative based on the test method itself, not on expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., image analysis by radiologists) where disagreements between evaluators need to be resolved to establish ground truth. For standardized laboratory performance tests, the results are objectively measured according to the test method and do not require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and therefore not provided in the document. An MRMC study is relevant for diagnostic devices where human readers interpret data, and the study assesses the impact of an AI alongside human readers. This submission is for a physical medical device (surgical mask) and involves laboratory performance testing, not diagnostic interpretation.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable and therefore not provided in the document. This device is a physical product (surgical mask), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used
For the performance and biocompatibility tests, the "ground truth" is established by objective measurements and results from standardized laboratory test methods (e.g., ASTM F2100-19, ASTM F2101-14, EN 14683: 2019, ASTM F2299-03, ASTM F1862/F1862M-17, 16 CFR Part 1610 for performance testing; ISO 10993-5:2009, ISO 10993-10:2010 for biocompatibility). These methods have predefined criteria for what constitutes a "Pass" or "Fail."
8. Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. The product is a physical medical device (surgical mask) and does not involve AI or machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided in the document, as there is no training set for this type of device.
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June 8, 2021
Shenzhen Peninsula Medical Co. Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K202126
Trade/Device Name: Disposable Surgical Mask (Model: Flat-type) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 11, 2021
Dear Cassie 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.
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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 (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,
Ryan Ortega, PhD Acting 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) K202126
Device Name Disposable Surgical Mask (Model: Flat-type)
Indications for Use (Describe)
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
| 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 for K202126
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
510(k) Owner's Name: Shenzhen Peninsula Medical Co. Ltd. Establishment Registration Number: 3016746323 Address: 3F Block A, Building F2, Changfeng Industrial Park, Liuxian 3rd Road, 68# Xin'an Street, Bao'an District, Shenzhen, 518100, P.R.China. Contact Person: Zhang Sudi Email: 283068426@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: June 8, 2021
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Surgical Mask Model Name: Flat-type Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
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4. Predicate Device Information
Sponsor: Acme Filter Mask Inc. Trade Name: Surgical Face Mask with Ear-Loop Classification Name: Mask, Surgical Common name: Surqical Mask 510(K) Number: K123115 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
5. Device Description
The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose.
The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.
6. Intended Use / Indications for Use
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
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| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Shenzhen Peninsula Medical Co.Ltd. | Acme Filter Mask Inc. | -- |
| 510 (k) | K202126 | K123115 | -- |
| Trade Name | Disposable Surgical Mask | Surgical Face Mask with Ear-Loop | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21CFR 878.4040) | Class II Device, FXX (21CFR 878.4040) | Same |
| Intended use | Disposable Surgical Mask isDevice that is intended to be wornby operating room personnelduring surgical procedures toprotect both the surgical patientand the operation room personnelfrom transfer of microorganisms,body fluids and particulatematerial. | Surgical Face Mask is Device thatis intended to be worn by operatingroom personnel during surgicalprocedures to protect both thesurgical patient and the operationroom personnel from transfer ofmicroorganisms, body fluids andparticulate material. | Same |
| Material | |||
| Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Same |
| Ear loops | Polyester | Polyester | Same |
| Design | Color: Blue | Color: Blue | Same |
| features | Ear loops | Ear loops | Same |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification | Length: 17.5cm+1cm | Length: 17.5cm+1cm | Same |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| andDimension | Width: 9.5cm±1cm | Width: 9.5cm±1cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| PerformanceTesting | Level 1 | Level 1 | Same |
| FluidResistancePerformance | Pass at 80 mmHg | Fluid Resistance | DifferentNote 1 |
| ParticulateFiltrationEfficiency | ≥ 95% | Average 94.79% for Solid AerosolFiltration EfficiencyEfficiency More than 99.5% forViral Filtration Efficiency | DifferentNote 1 |
| BacterialFiltrationEfficiency | ≥ 95% | pass at 99.9% | DifferentNote 1 |
| DifferentialPressure | < 5.0 mm H2O/cm² | pass at 3.3 mm H2O/cm² | DifferentNote 1 |
| Flammability | Class 1 | Class 1 | Same |
| Shelf life | 2 years | Not public | DifferentNote 2 |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study,the subject device extract wasdetermined to be non-cytotoxic. | Under the conditions of the study,the subject device extract wasdetermined to be non-cytotoxic. | Same |
| Irritation | Under the conditions of the study,the subject device non-polar andpolar extracts were determined tobe non-irritating. | Under the conditions of the study,the subject device non-polar andpolar extracts were determined tobe non-irritating. | Same |
| Sensitization | Under the conditions of the study,the subject device non-polar and | Under the conditions of the study,the subject device non-polar and | Same |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| polar extracts were determined tobe non-sensitizing. | polar extracts were determined tobe non-sensitizing. |
7. Comparison to predicate device and conclusion
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Comparison in Detail(s):
Note 1:
Although the "Fluid Resistance Performance", "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM F2100-19 level 1. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device when used as labeled.
Note 2:
Although the "Shelf life" of the subject device is different from the predicate device, the aging test showed that the requirements of essential performance standard ASTM F2100-19 level 1. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
8. Summary of Non-Clinical Performance Testing
- Performance Testing summary
| Test item(PerformanceLevel 1) | Test method | Pass criteria | Test results/Verdict |
|---|---|---|---|
| Bacterial filtrationefficiency | ASTM F2101-14Standard TestMethod forEvaluating theBacterial FiltrationEfficiency (BFE) ofMedical FaceMask Materials,Using a BiologicalAerosol of | ≥ 95% | 32/32 Passed at≥95% / Pass |
| Staphylococcusaureus accordingto ASTMF2100:2019 | |||
| Differentialpressure (Delta-P) | EN 14683: 2019,Annex C Medicalface masks -Requirements andtest methodsaccording to ASTMF2100:2019 | <5.0 mm H2O/cm² | 32/32 Passed at<5 mmH2O/cm² /Pass |
| Sub-micronparticulate filtrationefficiencyat 0.1 µm ofPolystyrene LatexSpheres | ASTM F2299-03Standard TestMethod forDetermining theInitial Efficiency ofMaterials Used inMedical FaceMasks toPenetration byParticulates UsingLatex Spheresaccording to ASTMF2100:2019 | ≥ 95% | 32/32 Passed at≥95% / Pass |
| Resistance topenetration bysyntheticblood, minimumpressure in mm Hgfor pass result | ASTMF1862/F1862M-17Standard TestMethod forResistance ofMedical Face Masksto Penetration bySynthetic Blood(Horizontal Projectionof Fixed Volume at a | Fluid resistantclaimedat 80 mm Hg | 32/32 Passed at80 mmHg/ Pass |
| Known Velocity)according to ASTMF2100:2019 | |||
| Flame spread | 16 CFR Part 1610Standard for theFlammability ofClothing accordingto ASTMF2100:2019 | Class 1 | 32/32 Passed ≥3Seconds burnTime-Class 1 /Pass |
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● Biocompatibility Testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|---|---|---|---|---|
| In vitro Cytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive. | ISO 10993-10:2010Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Under the research conditions, determine whether the non-polar and polar | ISO 10993-10:2010Biological evaluation of medical devices— Part 10: Tests for irritation | Under the conditions of the study, the subject device non-polar and polar | Pass |
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| extracts of the target | and skin sensitization | extracts were | ||
|---|---|---|---|---|
| device are irritating. | determined to be | |||
| non-irritating. |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202126, the Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K123115.
§ 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.