(29 days)
The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The TotalShield™ Surgical Helmet System is comprised of the TotalShield™ Zippered Surgical Toga, TotalShield™ Surgical Hood, TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED lighting and various accessories. The TotalShield™ Zippered Surgical Toga and/or TotalShield™ Surgical Hood are used with the TotalShield™ Helmet and/or TotalShield™ Advanced Surgical Helmet with LED lighting as the TotalShield™ Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED lighting have a battery powered fan, which provides a continuous flow of air in the TotalShield™ Surgical Hood or Zippered Surgical Toga. The TotalShield™ Surgical Hood is a stand-alone head cover that may be worn with a separate surgical gown, while the TotalShield™ Zippered Surgical Toga is a one-piece head and body cover. The stand-alone TotalShield™ Surgical Hood is identical to the hood that is incorporated into the TotalShield™ Zippered Surgical Toga. The TotalShield™ Surgical Hood or Zippered Surgical Toga must be worn over a TotalShield™ Surgical Helmet or Advanced Surgical Helmet with LED lighting. The TotalShield™ Zippered Surgical Toga has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2003 standard.
Here's a breakdown of the acceptance criteria and the study information for the TotalShield Surgical Helmet System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance criteria primarily through compliance with various industry standards and internal testing metrics. The key change highlighted is the barrier performance level of the Toga.
| Property | Acceptance Criteria (Predicate) | Reported Device Performance (Modified Device) |
|---|---|---|
| TotalShield™ Zippered Surgical Toga and Surgical Hood | ||
| Flammability of Clothing Textiles | Class 1 Compliant (ASTM F2100-07 reference 16 CFR-1610.4) | Class 1 Compliant - pass |
| Biological Evaluation on Skin Contact | Compliant (ISO-10993-10, ISO-10993-5, ISO-10993-10) | Compliant - pass |
| Sterility Method | Compliant (ISO 11607-2, ISO 11135-1, ISO 10993-7) | Compliant - pass |
| Tear Resistance | Compliant (ASTM D5733 MD Trap Tear), AAMI Level 3 | Compliant - pass |
| Tensile Strength | Compliant (ASTM D5034 Grab Tensile Strength) | Compliant - pass |
| Seam Strength | Compliant (ASTM D1683) | Compliant - passed seam test |
| Lint | Compliant (ISO 9073; EN 13795-2) | Compliant - pass |
| Water Vapor Transmission Rate | Compliant (ASTM E96 with Water) | Compliant - pass |
| Water resistance: Impact penetration | Compliant Level 3 (AAMI/ANSI PB70) | Compliant Level 4 (AAMI/ANSI PB70) |
| Hydrostatic pressure | Compliant Level 3 (AAMI/ANSI PB70) | Compliant Level 4 (AAMI/ANSI PB70) |
| Consensus Standards for barrier performance | Level 3 Barrier Performance AAMI/ANSI PB70:2003/(R)2009 | Level 4 Barrier Performance AAMI/ANSI PB70:2003/(R)2009 |
| Sterility Assurance Level | 10^-6 | Same (10^-6) |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED Lighting | ||
| Airflow Testing | Pass Acceptance Criteria (Internal Fan Performance Test Method) | Pass Acceptance Criteria |
| Helmet Noise Testing | Pass Acceptance Criteria (Internal Noise Measurement Test Method) | Pass Acceptance Criteria |
| Battery Life Testing | Pass Acceptance Criteria (Internal Battery Performance Test Method) | Pass Acceptance Criteria |
| Electrical safety and Environmental testing | Not explicitly stated as "acceptance criteria", but tests performed to IEC 60601-1 and IEC 60601-1-2 | Completed and passed |
| Device Usability testing | Not explicitly stated as "acceptance criteria", but tests conducted per IEC 60601-1-6 and IEC 62366:2007 | Conducted and passed |
| Sterilization Validation testing | Not explicitly stated as "acceptance criteria", but tests conducted per AAMI/ANSI/ISO 11607-1, 11607-2 and AAMI/ANSI/ISO 11135-1 | Conducted and passed |
| Shipping Validation | Not explicitly stated as "acceptance criteria", but tests conducted per ASTM D4169-09 | Conducted and passed |
| Biocompatibility Testing | Not explicitly stated as "acceptance criteria", but conducted per ISO 10993-1, ISO 10993-10, ISO 10993-5 and ISO 10993-7 | Conducted and passed |
| ASTM F2407-06 specifications | Adherence to specifications for requirements for performance, documentation, and labeling | Adheres to specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test. It refers to various ASTM, ISO, and AAMI standards, implying that the sample sizes were consistent with those standards.
- Sample Size: Not explicitly stated for individual tests. The tests were performed on the device components (Toga, Hood, Helmet).
- Data Provenance: Not specified, but generally, regulatory submissions like this involve data generated by the manufacturer or their contracted testing labs, typically within the country of manufacture or where the company operates (in this case, Zimmer Surgical, Inc. is based in Dover, OH, USA). The study is prospective in the sense that the testing was performed on the new device (modified device) to demonstrate its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a surgical helmet system, which is a physical barrier device, not an AI/software device that requires human expert review for "ground truth" establishment in the typical sense of medical image analysis or diagnostic AI. The "ground truth" for this device's performance is established by objective engineering and material science testing standards.
- Number of Experts: Not applicable in the context of establishing "ground truth" for a performance study of this type (physical device testing).
- Qualifications of Experts: The "experts" would be the certified testing laboratories and their personnel who conducted the tests according to the specified international standards (e.g., AAMI, ASTM, ISO). Their qualifications are inherent in their accreditation to perform such tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance is determined by objective measurements against established standard criteria, not by subjective human interpretation or consensus that would require 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 is not an AI/software device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the physical device's adherence to performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements against established performance standards (e.g., AAMI/ANSI PB70 for barrier performance, ISO standards for biocompatibility and sterility, ASTM standards for material strength and flammability). The device either passes or fails these pre-defined criteria.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Zimmer Surgical, Incorporated C/O Mr. Michael T. Wolford Regulatory Affairs Specialist 200 West Ohio Avenue Dover, OH 44622
Re: K142166
Trade/Device Name: TotalShield Surgical Helmet System Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 17, 2014 Received: July 30, 2014
Dear Mr. Wolford:
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. 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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Page 2 - Mr. Wolford
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K142166
Device Name TotalShield Surgical Helmet System
Indications for Use (Describe)
The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a bold, sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller, lighter font.
200 West Ohio Avenue Dover, Ohio 44622 330.343.8801
| 510(k)Summary | Sponsor: | Zimmer Surgical, Inc.200 West Ohio AvenueDover, OH 44622Phone: (330) 343-8801 | |
|---|---|---|---|
| Contact: | Michael T. WolfordRegulatory Affairs SpecialistPhone: (330) 364-9411 | ||
| Date: | July 17, 2014 | ||
| Trade Name: | TotalShield™ Surgical Helmet System | ||
| Product Code/Device: | FYA - Gown, Surgical | ||
| Regulation Number andDescription: | 21 CFR 878.4040 – Surgical Apparel | ||
| Predicate Device | TotalShield™ Surgical Helmet System K132386, clearedDecember 23, 2013. | ||
| Device Description | The TotalShield™ Surgical Helmet System is comprisedof the TotalShield™ Zippered Surgical Toga,TotalShield™ Surgical Hood, TotalShield™ SurgicalHelmet and Advanced Surgical Helmet with LEDlighting and various accessories. | ||
| The TotalShield™ Zippered Surgical Toga and/orTotalShield™ Surgical Hood are used with theTotalShield™ Helmet and/or TotalShield™ AdvancedSurgical Helmet with LED lighting as the TotalShield™Surgical Helmet System to provide a barrier between theoperating environment and the surgical personnel in orderto protect against contamination and/or exposure ofinfectious body fluids and harmful microorganisms. | |||
| The TotalShield™ Surgical Helmet and Advanced |
510(k) Summary of Safety and Effectiveness
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a white "Z" inside. Below the circle, the word "zimmer" is written in lowercase letters, with a line underneath. Below the line, the word "surgical" is written in smaller lowercase letters.
| Surgical Helmet with LED lighting have a batterypowered fan, which provides a continuous flow of air inthe TotalShield™ Surgical Hood or Zippered SurgicalToga. | |
|---|---|
| The TotalShield™ Surgical Hood is a stand-alone headcover that may be worn with a separate surgical gown,while the TotalShield™ Zippered Surgical Toga is a one-piece head and body cover. | |
| The stand-alone TotalShield™ Surgical Hood is identicalto the hood that is incorporated into the TotalShield™Zippered Surgical Toga. The TotalShield™ SurgicalHood or Zippered Surgical Toga must be worn over aTotalShield™ Surgical Helmet or Advanced SurgicalHelmet with LED lighting. | |
| The TotalShield™ Zippered Surgical Toga has beentested to meet the applicable AAMI PB70 standards forlevel 4 compliance. The AAMI standard does not coverapparel for the head, face, and eyes. Therefore, the hoodsand lens are exempt from classification under the AAMIPB70:2003 standard. | |
| Intended Use: | The TotalShield™ Zippered Surgical Toga and/orTotalShield™ Surgical Hood is for use with theTotalShield™ Surgical Helmet and/or TotalShield™Advanced Surgical Helmet with LED lighting as theTotalShield™ Surgical Helmet System that is intended tobe worn by surgical personnel to provide a barrierbetween the operating environment and the surgicalpersonnel in order to protect against contamination and/orexposure of infectious body fluids and harmfulmicroorganisms. |
| TechnologicalCharacteristics | The TotalShield Surgical Helmet System is substantiallyequivalent to the predicate device in that the devices havethe same technological characteristics, including:Has the same intended use, target population andindications for use as the predicate Uses the same operating principles Incorporates the same basic design of durablehelmet and single-use hoods and togas Hood and toga are sterilized using the same mode Both are sterilized to SAL 10-6 Reusable helmets are provided non-sterile Is manufactured of similar materials |
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue letter Z inside of a blue circle. Below the circle, the word "zimmer" is written in a blue, sans-serif font. Below the word "zimmer", the word "surgical" is written in a smaller, sans-serif font.
The TotalShield™ Surgical Helmet System is Comparison to Predicate: substantially equivalent to the legally marketed predicate device, TotalShield™ Surgical Helmet System, in that these devices have the same intended use and are similar in design. The following tables provide a comparison between the predicate device and modified device:
| Property | Predicate: TotalShield™ Surgical HelmetSystem | Modified Device: TotalShield™Surgical Helmet System |
|---|---|---|
| Intended Use | The TotalShield™ Zippered Surgical Togaand /or TotalShield™ Surgical Hood is foruse with the TotalShield™ Surgical Helmetand/or TotalShield™ Advanced SurgicalHelmet with LED Lighting as theTotalShield™ Surgical Helmet System thatis intended to be worn by surgicalpersonnel to provide a barrier betweenthe operation environment and thesurgical personnel in order to protectagainst contamination and/or exposure ofinfectious body fluids and harmfulmicroorganisms. | Same |
| TargetPopulation | Operating Room Personnel | Same |
Materials of Construction
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Image /page/6/Picture/0 description: The image contains the logo for Zimmer Surgical. The logo features a stylized blue letter "Z" enclosed in a circle. Below the circle, the word "zimmer" is written in a sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.
| Property | Predicate: TotalShield TM Surgical HelmetSystem K132386 | Modified Device: TotalShield TM Surgical Helmet System |
|---|---|---|
| Toga and Hood | SMS nonwoven fabric | BVB nonwoven fabric |
| Lens/Face Shield | PETG Clear Copolyester | Same |
| Filter | Blended Synthetic Fiber SpunboundPolypropylene | Same |
| Helmet | Plastic | Same |
| LED Components | Aluminum, Stainless Steel | Same |
Technology and Product Features
| Property | Predicate: TotalShield™ SurgicalHelmet System | Modified Device: TotalShield™ SurgicalHelmet System |
|---|---|---|
| TotalShield™ Zippered Surgical Toga and Hood | ||
| OperatingPrinciple | The TotalShield™ Zippered Surgical Togahas been designed to properly fit theTotalShield™ Surgical Helmet andAdvanced Surgical Helmet with LEDLighting in order to be used together asthe TotalShield™ Surgical HelmetSystem. The TotalShield™ ZipperedSurgical Toga or Surgical Hood isfastened to either the TotalShield™Surgical Helmet or Advanced SurgicalHelmet with LED Lighting with aid ofhook-and-loop fasteners and mechanicalslot. The device acts as a barrierbetween the operating environment andthe surgical personnel. | Same |
| AdjustableLength (Toga) | Tear away feature (12" from length) | Same |
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Image /page/7/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.
| ConsensusStandards | Level 3 Barrier Performance AAMI/ANSIPB70:2003/(R)2009ASTM F2407-06 Standard Specificationfor Surgical Gowns Intended for Use inHealthcare Facilities | Level 4 Barrier Performance AAMI/ANSIPB70:2003/(R)2009ASTM F2407-06 Standard Specificationfor Surgical Gowns Intended for Use inHealthcare Facilities |
|---|---|---|
| SterilityAssurance Level | $10^{-6}$ | Same |
| Condition of Use | Single Use/Disposable | Same |
| Closure | Toga Neck tie/waist tieHood pull over | Same |
| Toga Sizes | Regular, Large, Extra Large | Same |
| Color | Blue | Same |
| TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED Lighting | ||
| Method of HoodAttachment | Mechanical slot and hook-and-loop | Same |
| Lighting Option | LED | Same |
Performance Comparison
| Property orCharacteristic | Testing Method | Predicate:TotalShield™Surgical HelmetSystem | Modified Device:TotalShield™Surgical HelmetSystem |
|---|---|---|---|
| TotalShield™ Zippered Surgical Toga and Surgical Hood | |||
| Flammability ofClothing Textiles | ASTM F2100-07 reference 16CFR-1610.4 | Class 1 Compliant-pass | Class 1 Compliant-pass |
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Image /page/8/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.
| BiologicalEvaluationon Skin Contact | ISO-10993-10 IntracutaneousReactivity TestISO-10993-5 MEM Elution Assaywith L-929 MouseFibroblast CellsISO-10993-10 Guinea PigMaximization Sensitization Test | Compliant- pass | Compliant- pass |
|---|---|---|---|
| Sterility Method | ISO 11607-2 PackagingValidationISO 11135-1 EO ValidationISO 10993-7 EO Residual Test | Compliant- pass | Compliant- pass |
| Tear Resistance | ASTM D5733 MD Trap TearCompliant- pass AAMI Level 3 | Compliant- pass | Compliant- pass |
| Tensile Strength | ASTM D5034 Grab TensileStrength | Compliant- pass | Compliant- pass |
| Seam Strength | ASTM D1683 | Compliant- passedseam test | Compliant- passedseam test |
| Lint | ISO 9073; EN 13795-2 Testmethods for surgicaldrapes, gowns and clean airsuits, used as medicaldevices for patients, clinicalstaff and equipment | Compliant- pass | Compliant- pass |
| Water VaporTransmission Rate | ASTM E96 with Water | Compliant- pass | Compliant- pass |
| Water resistance:ImpactpenetrationHydrostaticpressure | AAMI/ANSI PB70 | Compliant Level 3 | Compliant Level 4 |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED Lighting |
| Airflow Testing | Internal Fan Performance TestMethod | Pass AcceptanceCriteria | Pass AcceptanceCriteria |
|---|---|---|---|
| Helmet NoiseTesting | Internal Noise MeasurementTest Method | Pass AcceptanceCriteria | Pass AcceptanceCriteria |
| Battery LifeTesting | Internal Battery PerformanceTest Method | Pass AcceptanceCriteria | Pass AcceptanceCriteria |
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Image /page/9/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue letter Z inside of a circle. Below the circle is the word "zimmer" in blue, and below that is the word "surgical" in gray.
| Non-Clinical PerformanceDescription: | During the design and development of the TotalShield™Surgical Helmet System, the following tests werecompleted: |
|---|---|
| Electrical safety and Environmental testing (IEC60601-1 and IEC 60601-1-2) Device Usability testingwas conducted in accordance with requirements of IEC60601-1-6 and IEC 62366:2007. | |
| Sterilization Validation testing was conducted inaccordance with AAMI/ANSI/ISO 11607-1, 11607- 2and AAMI/ANSI/ISO 11135-1. Shipping Validation wasconducted according to ASTM D4169-09. | |
| Biocompatibility Testing was conducted on skin contactmaterial in accordance with ISO 10993-1, ISO 10993-10,ISO 10993-5 and ISO 10993-7. | |
| Non-Clinical testing was conducted to demonstrate thatthe subject device performed as intended and met allacceptance criteria, including:• Airflow Testing• Helmet Noise Testing• Battery Life Testing• Liquid Barrier testing (per AAMI/ANSIPB70 Level 4, for Surgical Zippered Toga only) | |
| The TotalShield™ Surgical Helmet System adheres to thespecifications for requirements for performance,documentation, and labeling per ASTM F2407-06. | |
| Clinical Performance | No Clinical evaluations necessary for this device |
| Conclusion | All tests passed according to predetermined acceptancecriteria, thus demonstrating equivalent performance of thesubject device to the predicate 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.