(162 days)
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, provided non-sterile.
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.
However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.
1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:
The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."
Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)
| Test Item & Purpose | Acceptance Criteria (Level 2) | Reported Performance (Level 2) | Acceptance Criteria (Level 3) | Reported Performance (Level 3) | Result (Both Levels) |
|---|---|---|---|---|---|
| Performance Test: Flammability | Class 1 (ASTM F2100) | Class 1 | Class 1 (ASTM F2100) | Class 1 | Pass |
| Purpose: Testing the characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion. | |||||
| Performance Test: Bacterial Filtration Efficiency (BFE) | ≥ 98% (ASTM F2100) | Average at 99.66% | ≥ 98% (ASTM F2100) | Average at 99.58% | Pass |
| Purpose: Testing the effectiveness of medical face mask material in preventing the passage of aerosolized bacteria. | |||||
| Performance Test: Differential Pressure (mm H2O/cm²) | < 6.0 (ASTM F2100) | 4.4 mm H2O/cm² | < 6.0 (ASTM F2100) | 5.06 mm H2O/cm² | Pass |
| Purpose: Measuring the pressure drop across a medical face mask material. | |||||
| Performance Test: Sub-Micron Particle Filtration Efficiency (PFE) | ≥ 98% (ASTM F2100) | Average at 99.54% | ≥ 98% (ASTM F2100) | Average at 99.67% | Pass |
| Purpose: Testing the efficiency of the filter material in capturing aerosolized particles smaller than one micron. | |||||
| Performance Test: Resistance to Penetration by Synthetic Blood | Pass at 120 mmHg (ASTM F2100) | Passed at 120 mmHg (≥29 out of 32 samples passed) | Pass at 160 mmHg (ASTM F2100) | Passed at 160 mmHg (≥29 out of 32 samples passed) | Pass |
| Purpose: Testing the efficiency of resistance to penetration by synthetic blood. | |||||
| Biocompatibility: Cytotoxicity | Grade ≤ 2 (ISO 10993-5) | Not explicitly stated as "Pass" but under "Comparison Table" it says "Fail" for both levels against the predicate's "not cytotoxic" | Grade ≤ 2 (ISO 10993-5) | Not explicitly stated as "Pass" but under "Comparison Table" it says "Fail" for both levels against the predicate's "not cytotoxic" | Fail |
| Purpose: Determining the cytotoxicity of proposed device. | |||||
| Biocompatibility: Sensitization | Sensitization classification grade < 3 (ISO 10993-10) | Not a sensitizer | Sensitization classification grade < 3 (ISO 10993-10) | Not a sensitizer | Pass |
| Purpose: Determining whether the proposed device has sensitization potential. | |||||
| Biocompatibility: Skin Irritation | Reaction score is 1, 0 or less (ISO 10993-10) | Not an irritant | Reaction score is 1, 0 or less (ISO 10993-10) | Not an irritant | Pass |
| Purpose: Determining whether the proposed device has irritation potential. | |||||
| Biocompatibility: Acute Systemic Toxicity | Less than 2 animals appear clinical abnormal and body weight loss ≤ 10% (ISO 10993-11) | No systemic toxicity from the device | Less than 2 animals appear clinical abnormal and body weight loss ≤ 10% (ISO 10993-11) | No systemic toxicity from the device | Pass |
| Purpose: Determining whether the proposed device has systemic toxicity potential. | |||||
| Simulated Transportation | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | No damage on packaging and products after DC 13 procedure of ASTM D4169 | Pass |
| Purpose: Determining the ability of shipping units to withstand the distribution environment. |
Note on Cytotoxicity: The comparison table explicitly states "Fail" for cytotoxicity, even though the reported result in the detailed performance tables states "show potential cytotoxicity" and a criterion of "Grade ≤ 2". This is a critical point of difference from the predicate device which was "not cytotoxic." The FDA's clearance likely implies that this difference did not raise new questions of safety or effectiveness given the overall risk-benefit profile for this type of device.
2. Sample size used for the test set and the data provenance:
- Sample Size: For Flammability, Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particle Filtration Efficiency, and Resistance to Penetration by Synthetic Blood, the testing was conducted on samples from "3 non-consecutive lots." The number of individual samples tested per lot is indicated for Flammability and Resistance to Penetration by Synthetic Blood, showing 32 out of 32 pass for flammability and ≥29 out of 32 pass for synthetic blood penetration. The exact sample sizes for BFE, Differential Pressure, and PFE for each lot are not explicitly stated as a count, but they are implied to be sufficient for generating the reported average percentages/values from the 3 lots.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission from "Foshan Nanhai Plus Medical CO LTD" in China. The testing appears to be retrospective as it is presented as completed performance data for a device already manufactured.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the tests described. The "ground truth" for the performance tests (e.g., BFE, PFE) is established by the standardized testing protocols (e.g., ASTM F2100) and laboratory measurements, not by expert consensus or interpretation of images/clinical data. For biocompatibility, it's based on standard biological evaluation protocols (e.g., ISO 10993 series).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests are laboratory-based measurements with defined pass/fail criteria, not subjective assessments requiring expert 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:
- Not applicable. This document pertains to a physical medical device (surgical face mask) and its performance characteristics, not an AI/Machine Learning algorithm. No MRMC study was conducted or is relevant to this device's evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is derived from standardized physical and chemical testing methods using established protocols (e.g., ASTM F2100 for filtration, differential pressure, flammability, synthetic blood penetration; ISO 10993 for biocompatibility). The results are quantitative measurements against predefined criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device; thus, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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January 26, 2022
Foshan Nanhai Plus Medical CO LTD % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K212610
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 21, 2021 Received: December 27, 2021
Dear Olivia Meng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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 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 Clarence W. Murray, III, Ph.D. 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) K212610
Device Name Surgical Face Mask
Indications for Use (Describe)
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, provided non-sterile.
Level 2 Surgical Face Mask Models: Tie strap type: 522-001, 522-003, 522-005 Ear loop type: 522-002, 522-004, 522-006 Level 3 Surgical Face Mask Models: Tie strap type: 533-001, 533-003, 533-005 Ear loop type: 533-002, 533-004, 533-006
| 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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K212610
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Foshan Nanhai Plus Medical CO LTD Shijiang Industrial Zone, Shatou, Jiujiang Town, Nanhai, Foshan City, Guangdong, China Phone: +86-757-86914198 Fax: +86-755-27343466
| Primary Contact Person: | Olivia MengRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical Service Co., Ltd.Tel: (+86)-20-6231 6262Fax: (+86)-20-8633 0253 |
|---|---|
| Secondary Contact Person: | Suyi LiRegulatory Affairs ManagerFoshan Nanhai Plus Medical CO LTDPhone: +86-757-86914198Fax: +86-755-27343466 |
| Date prepared | Dec 19th , 2021 |
| 2. DEVICE | |
| Device Name: | Surgical face mask |
| Common name: | Mask, Surgical |
| Model: | 522-001, 522-002, 522-003, 522-004, 522-005, 522-006, 533-001, 533-002, 533-003, 533-004, 533-005, 533-006 |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FXX |
3. PREDICATE DEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall.
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4. DEVICE DESCRIPTION
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use.
The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free.
lt is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
| Model# | Ear Type | ASTM F2100 Level |
|---|---|---|
| 522-001 | Tie strap | |
| 522-002 | Ear loop | Level 2 |
| 522-003 | Tie strap | |
| 522-004 | Ear loop | |
| 522-005 | Tie strap | |
| 522-006 | Ear loop | |
| 533-001 | Tie strap | |
| 533-002 | Ear loop | Level 3 |
| 533-003 | Tie strap | |
| 533-004 | Ear loop | |
| 533-005 | Tie strap | |
| 533-006 | Ear loop |
Twelve models are included in this submission, the differences listed below:
Six models including 522-001, 522-002, 522-004, 522-005, 522-005, 522-006 are level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- Bacterial filtration efficiency (BFE) ≥98%
- Sub-micron particle filtration efficiency ≥98%
- Different pressure: <6.0 mm H2O/cm2
- Flammability: class 1
- Resistance to penetration by synthetic blood: 120 mmHg
Six models including 533-001, 533-002, 533-003, 533-005, 533-006 are level 3 according to ASTM F2100-19. The main parameters of the product are listed as followed:
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- Bacterial filtration efficiency (BFE) ≥98%
- Sub-micron particle filtration efficiency ≥98%
- Different pressure: <6.0 mm H2O/cm²
- Flammability: class 1
- Resistance to penetration by synthetic blood: 160 mmHg
INDICATIONS FOR USE 5.
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, provided non-sterile.
| Item | Proposed device | Predicate device | Comparison result | |
|---|---|---|---|---|
| Manufacturer | Foshan Nanhai Plus Medical CO LTD | San-M Package Co., Ltd. | NA | |
| 510K Number | K212610 | K160269 | NA | |
| Product Common Name | Surgical face mask | Surgical Face Masks (Ear loops and Tie-on) | NA | |
| Intended Use | 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, 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, provided non-sterile. | Same | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Ear loop, tie strapColors: white or blueNo visor option | Ear loop, tie-onColors: white or blueVisor option: polyester | Similar | |
| Material of outer facing layer | Polypropylene nonwoven | Polypropylene | Same | |
| Material of middle layer | Polypropylene meltblown nonwoven | Polypropylene meltblown and polypropylene spunbond | Similar | |
| Material of inner facing layer | Polypropylene nonwoven | Polypropylene | Same | |
| Nosepiece | Galvanized iron wire wrapped with polyethylene(PE) | Polypropylene coated steel wire | Similar | |
| Attachment | Ear loops: Spandex elasticTie strap: Polypropylenenonwoven | Ear loops: Polyester, polyurethaneSide tapes: Polyester spunbond(ear loops mask only)Tie tapes: Polypropylenespunbond or polyester spunbond | Similar | |
| Dimension(Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm18.0 cm × 9.0 cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Single use | Yes | Yes | Same | |
| ASTM F 2100level | Level 2Level 3 | Level 1Level 2Level 3 | Similar | |
| Flammability | For 3 non-consecutive lots,32 out of 32 pass.Level 2: Class 1Level 3: Class 1 | Level 1: Class 1Level 2: Class 1Level 3: Class 1 | Similar | |
| BacterialFiltrationEfficiency | For 3 non-consecutive lots,32 out of 32 pass.Level 2: average at 99.66%Level 3: average at 99.58% | Level 1: > 98%Level 2: > 98%Level 3: > 99% | Similar | |
| DifferentialPressure | For 3 non-consecutive lots,32 out of 32 pass.Level 2: 4.4 mm $H_2O/cm^2$Level 3: 5.06 mm $H_2O/cm^2$ | Level 1: pass at 2.0 mm $H_2O/cm^2$Level 2: pass at 1.6 mm $H_2O/cm^2$Level 3: pass at 2.5 mm $H_2O/cm^2$ | Similar | |
| Sub-MicronParticle FiltrationEfficiency | For 3 non-consecutive lots,32 out of 32 pass.Level 2: average at 99.54%Level 3: average at 99.67% | Level 1: 99.6%Level 2: 99.6%Level 3: 99.7% | Similar | |
| Resistance toPenetration bySynthetic Blood | For 3 non-consecutive lots,≥29 out of 32 pass(which met the requirements).Level 2: at 120 mmHgLevel 3: at 160 mmHg | Level 1: pass at 80 mmHgLevel 2: pass at 120 mmHgLevel 3: pass at 160 mmHg | Similar | |
| Biocompatibility | ||||
| Cytotoxicity | Under the conditions of thestudy, show potential cytotoxicity. | Under the conditions of the study,not cytotoxic. | Different | |
| Irritation | Under the conditions of thestudy, not an irritant. | Under the conditions of the study,not an irritant. | Same | |
| Sensitization | Under conditions of the study,not a sensitizer. | Under conditions of the study, nota sensitizer. | Same | |
| Acute systemictoxicity | Under the conditions of thestudy, no systemic toxicity fromthe device. | -- | Similar | |
| Test item | Test purpose | Acceptance criteria | Results | |
| Performancetest | Flammability | Testing the characteristics of amaterial that pertain to its relative ease of ignition and relativeability to sustain combustion. | Class 1ASTM F2100 | Pass |
| Bacterial FiltrationEfficiency | Testing the effectiveness ofmedical face mask material inpreventing the passage ofaerosolized bacteria. | Level 2: ≥ 98%ASTM F2100 | Pass | |
| Different Pressure,mm H2O/cm² | Measuring the pressure ofdropping across a medical facemask material. | Level 2: < 6.0ASTM F2100 | Pass | |
| Sub-MicronParticle FiltrationEfficiency | Testing the efficiency of thefilter material in capturingaerosolized particles smallerthan one micron. | Level 2: ≥ 98%ASTM F2100 | Pass | |
| Resistance toPenetration bysynthetic blood | Testing the efficiency ofresistance to penetration bysynthetic blood. | Level 2: pass at120 mmHgASTM F2100 | Pass | |
| Biocompatibility | Cytotoxicity | Determining the cytotoxicity ofproposed device. | Grade ≤ 2ISO 10993-5 | Fail |
| Sensitization | Determining whether theproposed device hassensitization potential. | Sensitizationclassification grade < 3ISO 10993-10 | Pass | |
| Skin Irritation | Determining whether theproposed device has irritationpotential. | Reaction score is 1,0 orlessISO 10993-10 | Pass | |
| Acute systemictoxicity | Determining whether theproposed device has systemictoxicity potential. | Less than 2 animalsappear clinicalabnormal and bodyweight loss ≤ 10%ISO 10993-11 | Pass | |
| Test item | Test purpose | Acceptance criteria | Results | |
| Performancetest | Flammability | Testing the characteristics of amaterial that pertain to its relative ease of ignition and relative ability to sustain combustion. | Class 1ASTM F2100 | Pass |
| Bacterial FiltrationEfficiency | Testing the effectiveness ofmedical face mask material inpreventing the passage ofaerosolized bacteria. | Level 3: ≥ 98%ASTM F2100 | Pass | |
| Different Pressure,mm H2O/cm² | Measuring the pressure ofdropping across a medical facemask material. | Level 3: < 6.0ASTM F2100 | Pass | |
| Sub-MicronParticle FiltrationEfficiency | Testing the efficiency of thefilter material in capturingaerosolized particles smallerthan one micron. | Level 3: ≥ 98%ASTM F2100 | Pass | |
| Resistance toPenetration bysynthetic blood | Testing the efficiency ofresistance to penetration bysynthetic blood. | Level 3: pass at160 mmHgASTM F2100 | Pass | |
| Biocompatibility | Cytotoxicity | Determining the cytotoxicity ofproposed device. | Grade ≤ 2ISO 10993-5 | Fail |
| Sensitization | Determining whether theproposed device hassensitization potential. | Sensitizationclassification grade < 3ISO 10993-10 | Pass | |
| Skin Irritation | Determining whether theproposed device has irritationpotential. | Reaction score is 1,0 orlessISO 10993-10 | Pass | |
| Acute systemictoxicity | Determining whether theproposed device has systemictoxicity potential. | Less than 2 animalsappear clinicalabnormal and bodyweight loss ≤ 10%ISO 10993-11 | Pass | |
| Simulated transportation | Determining the ability ofshipping units to withstand thedistribution environment. | No damage onpackaging andproducts after DC 13procedure of ASTMD4169 | Pass |
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The differences between the Surgical face mask and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Surgical face mask should perform as intended in the specified use conditions.
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Level 2 product:
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Level 3 product:
8. SUMMARY of CLINICAL TESTING
Clinical testing is not applicable to the subject device.
9. CONCLUSION
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.