(60 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
This document is a 510(k) Premarket Notification for a Surgical Mask, specifically models GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, and GFM 80, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.
The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K210147). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical testing conducted to show the device meets specific requirements for surgical masks and is equivalent to the predicate.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria for Level 3 Barrier | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥98% | Passed (Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%) |
| Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask | <6.0 mmH2O/cm² | Passed (Lot 1: <6.0, Lot 2: <6.0, Lot 3: <6.0) |
| Sub-micron Particulate Filtration Efficiency (ASTM F2299-17) | Measure initial particle filtration efficiency | ≥98% | Passed (Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%) |
| Resistance to Penetration by Synthetic Blood (ASTM F1862-17) | Evaluate resistance to penetration by impact of synthetic blood | 29 out of 32 pass at 160 mmHg | Passed (Lot 1: 32 out of 32 pass, Lot 2: 32 out of 32 pass, Lot 3: 32 out of 32 pass) |
| Flammability (16 CFR Part 1610-2008) | Response of materials to heat and flame | Class I | Passed (Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1) |
| Biocompatibility Evaluation: | |||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Passed (Non-cytotoxic) | |
| Sensitization (ISO 10993-10) | Non-sensitizing | Passed (Non-sensitizing) | |
| Irritation (ISO 10993-10) | Negligibly irritating | Passed (Negligibly irritating) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Bacterial Filtration, Differential Pressure, Particulate Filtration, Synthetic Blood Penetration, Flammability), 3 non-consecutive lots were tested, using a sample size of 32 devices per lot.
- Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the independent labs were located). It mentions the applicant's address as "JINGZHOU HUBEI, CHINA." The study is a non-clinical study, which typically means lab testing, not patient-derived data, so the terms "retrospective" or "prospective" are not applicable in their usual clinical sense. The tests were performed to demonstrate compliance with recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is a non-clinical device performance and safety study, not a study involving medical imaging or clinical diagnosis where experts establish ground truth.
- The "ground truth" for these tests is defined by the established ASTM, EN, ISO, and CFR standards themselves (e.g., a specific filtration efficiency percentage, a specific pressure drop value, etc.). The tests are quantitative measurements against these predefined objective criteria.
- The document does not mention the number or qualifications of experts involved in "establishing ground truth" in the way one would for diagnostic AI. The expertise would lie in the accredited labs and personnel performing the standardized tests.
4. Adjudication Method for the Test Set
- Not applicable. This is a non-clinical, quantitative performance testing of a physical device against specified standards. Results are direct measurements, not subject to human adjudication or consensus in the way clinical interpretations are.
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 submission is for a surgical mask, a physical medical device, not an AI or diagnostic imaging device that assists human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm. The "standalone" performance here refers to the intrinsic physical properties and performance of the mask as measured by the specified tests.
7. The Type of Ground Truth Used
- The "ground truth" for these non-clinical tests are the quantitative performance specifications defined by internationally recognized standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610 for performance, and ISO 10993-5, ISO 10993-10 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this context.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. The "training set" concept is relevant for machine learning/AI models. For device manufacturing, the "training" involves process control and quality assurance to meet specifications, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above (physical device, not an AI model). Quality control and manufacturing processes ensure the device is produced to meet the established performance specifications.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2022
Jingzhou Haixin Green Cross Medical Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K222266
Trade/Device Name: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 28, 2022 Received: July 28, 2022
Dear Ivy Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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
Submission Number (if known)
K22266
Device Name
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 21st, July, 2022
A. Applicant:
Name: JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD. Address: YONGXING NORTH ROAD NO.2 JINGZHOU HUBEI, CHINA Contact: Lei Da Title: General Manager Tel: 86-27-82836722 Fax: 86-27-82770267 Email: inquiry@hh-greencross.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device: Trade Name: Surgical Mask Model: GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device: (Primary)
K210147 Proprietary Name: Unico High Performance Surgical Mask Unico High Performance Surgical Mask with Face Shield Common Name: Surgical Mask Classification Name: Surgical Mask (21 CFR 878.4040)
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Regulatory Class: II Product Code: FXX
D. Indications for use of the device:
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
F. Non-clinical Test Conclusion
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The Surgical Masks were tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Test Methodology | Purpose | Acceptance Criteriafor Level 3 Barrier | Result |
|---|---|---|---|
| Bacterial FiltrationEfficiencyASTM F2101 | Measure bacterialfiltration efficiency | ≥98% | Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: ≥98%Lot 2: ≥98%Lot 3: ≥98% |
| Differential Pressure(mmH2O/cm²)EN 14683:2019Annex C | Determine breathabilityof the mask | <6.0 mmH2O/cm² | Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: <6.0Lot 2: <6.0Lot 3: <6.0 |
| Sub-micronParticulate FiltrationEfficiency ASTMF2299-17 | Measure initial particlefiltration efficiency | ≥98% | Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: ≥98%Lot 2: ≥98%Lot 3: ≥98% |
| Resistance toPenetration bySynthetic BloodASTM F1862-17 | Evaluate the resistance topenetration by impact ofsmall volume of syntheticblood | 29 out of 32 pass at160 mmHg | Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: 32 out of 32 pass at 160 mmHgLot 2: 32 out of 32 pass at 160 mmHgLot 3: 32 out of 32 pass at 160 mmHg |
| Flammability16 CFR Part1610-2008 | Response of materials toheat and flame | Class I | Passed3 non-consecutive lots tested, using asample size of 32/lotLot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
Biocompatibility Testing
The biocompatibility evaluation for the Surgical Mask was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Medical Surgical Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
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| JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD. |
|---|
| YONGXING NORTH ROAD NO.2 JINGZHOU HUBEI, CHINA |
| Biocompatibility Evaluation | ||||
|---|---|---|---|---|
| Biological Effect | Standard | Result | ||
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
G. Summary of Technological Characteristics
Table 1 Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | - | K210147 | - |
| Manufacturer | JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD. | Unicoglobal, Inc. | - |
| Product Name and Models | Surgical MaskGFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80 | Unico High Performance Surgical Mask with Face ShieldUnico High Performance Surgical Mask | Similar |
| Design Feature | GFM 96 - three-layer, flat-pleated with ear loopsGFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clipGFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shieldGFM 88 - three-layer, flat-pleated with tiesGFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clipGFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield | Ear loops or tie-on, flat pleated, 4 layers with eye shied and anti-glare strip | Different |
| Level | Level 3 | Level 3 | Same |
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for use | The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection | The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and | Same |
| control practices to reduce the potential | particulate material. These facemasks are intended for use in | ||
| exposure to blood and body fluids. This asingle use, disposable device(s), providednon-sterile. | infection control practices to reducepotential exposure to blood and bodyfluids. The face masks are single use, disposable device, providednon-sterile. | ||
| Color | Blue | Blue and Green | Similar |
| Dimension | Length: $17.5\pm0.5$ cmWidth: $9.5\pm0.5$ cm | Length: 6.9" $\pm$ 0.2"Width: 3.74" $\pm$ 0.2" | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Material | |||
| Outer layer | Spunbond polypropylene | Polypropylene Spunbond | Same |
| Middle layer | Melt-blown polypropylene | Polypropylene Spunbond andPolypropylene Meltblown | Different |
| Inner layer | Spunbond polypropylene | Polypropylene Spunbond | Same |
| Nose clip | Polypropylene wrapped metalWith or without additional foam strip | PVC Coated Zinc Wire | Different |
| Ear loops | polyester and spandex | Cotton 50%Spandex 50% cord | Different |
| Tie Strings | Spunbond polypropylene | Polypropylene Spunbond | Same |
| Eye Shield | Polyethylene terephthalate | Protective film: Polyethylene 100%Film: Polyethylene terephthalate100% | Different |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3 | |||
| ParticulateFiltrationEfficiency (PFE) | Passed at ≥98%ASTM F2299 | Passed at ≥98%ASTM F2299 | Same |
| FluidResistance | Passed at 160mm HgASTM F1862 | Passed at 160mm HgASTM F1862 | Same |
| BacterialFiltrationEfficiency (BFE) | Passed at ≥98%ASTM F2101 | Passed at ≥98%ASTM F2101 | Same |
| DifferentialPressure | Passed at <6 mmH2O/cm²MIL-M36954C | Passed at <6 mmH2O/cm²MIL-M36954C | Same |
| Flammability | Class I | Class I | Same |
| Biocompatibility | |||
| Result | Non-cytotoxic, Nonsensitizing,Non-irritating | Non-cytotoxic, Nonsensitizing,Non-irritating | Same |
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Difference Analysis:
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The proposed device has different product models to the predicate device. The proposed device has six models. The model with the most complex configuration, which has anti-fog foam strip attached to nose clip and eye shield, is similar to the predicate device in regards of design. Other models of the proposed device has no foam strip attached to nose clip or eye shield, which will not raise any concern in safety and effectiveness.
The proposed device has different layer number and materials of middle layer, nose clip and shield. But non-clinical performance tests and the biocompatibility tests have been performed on the proposed device according to ASTM F2100, ISO 10993-5 and ISO 10993-10 respectively and the results do not show any adverse effect.
The subject device and the predicate device have the same indications for use and dimension, and has similar design and technological characteristics. Therefore, the above-mentioned differences will not affect the safety and effectiveness between the proposed device and the predicate device.
H. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
- A ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
-
ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
EN 14683, Medical Face Masks - Requirements and Test Methods
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials. Using a Biological Aerosol of Staphylococcus Aureus
-
ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
Clinical Test Conclusion I.
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Medical Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210147.
§ 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.