(144 days)
The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood is for use with the TotalShield Surgical Helmet and/or TotalShield Advanced Surgical Helmet with LED lighting as the TotalShield 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 Zippered Surgical Toga and/or TotalShield Surgical Hood are used with the TotalShield Surgical 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 3 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.
The TotalShield™ Surgical Helmet System, including the TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood, is designed to be worn by surgical personnel to create a barrier and protect against contamination and exposure to infectious body fluids and harmful microorganisms. The device's performance was evaluated through a series of internal and consensus standard tests, demonstrating its equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Property or Characteristic | Acceptance Criteria / Testing Method | Reported Device Performance (TotalShield Surgical Helmet System) | Reported Device Performance (Predicate: Freedomaire ®III Surgical Helmet System) |
|---|---|---|---|
| Surgical Toga and Surgical Hood | |||
| Flammability of Clothing Textiles | ASTM F2100-07 reference 16 CFR-1610.4 | Class 1 Compliant - Pass | Compliant |
| Biological Evaluation on Skin Contacting Material | ISO-10993-11 Acute Systemic Injection TestISO-10993-10 Intracutaneous Reactivity TestISO-10993-5 MEM Elution Assay with L-929 Mouse Fibroblast CellsISO-10993-10 Guinea Pig Maximization Sensitization Test | Compliant - Pass | Compliant |
| Sterility Method | ISO 11607-2 Packaging ValidationISO 11135-1 EO ValidationISO 10993-7 EO Residual Test | Compliant - Pass | Compliant |
| Tear Resistance | ASTM D5733 MD Trap Tear | Compliant - Pass | AAMI Level 3 |
| Grab Tensile Strength | ASTM D5733 CD Grab Tensile Strength | Compliant - Pass | AAMI Level 3 |
| Seam Strength | ASTM D1683 | Compliant - Passed seam test | AAMI Level 3 |
| Lint | ISO 9073; EN 13795-2 | Compliant - Pass | AAMI Level 3 |
| Water Vapor Transmission Rate | ASTM D6701 | Compliant | AAMI Level 3 |
| Water resistance: Impact penetration, Hydrostatic pressure | AAMI/ANSI PB70 | Compliant Level-3 | Compliant Level-3 |
| Surgical Helmet and Advanced Surgical Helmet with LED lighting | |||
| Airflow Testing | Internal Fan Performance Test Method | Passed Acceptance Criteria | Passed Acceptance Criteria |
| Helmet Noise Testing | Internal Noise Measurement Test Method | Passed Acceptance Criteria | Passed Acceptance Criteria |
| Battery Life Testing | Internal Battery Performance Test Method | Passed Acceptance Criteria | Passed Acceptance Criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the test set. However, it indicates that "all tests passed according to predetermined acceptance criteria," suggesting that a sufficient number of samples were tested to demonstrate compliance with the referenced standards.
The data provenance is from non-clinical performance testing conducted by Zimmer Surgical, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location in Dover, OH, USA. The studies are by nature prospective as they were conducted during the development process to ensure the device met safety and effectiveness standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of medical device (surgical apparel and helmet system) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic imaging device would. The "ground truth" for the performance tests listed (e.g., flammability, sterility, material strength, barrier properties, airflow, noise, battery life) is established by adherence to recognized consensus standards (e.g., ASTM, ISO, AAMI/ANSI). Therefore, the "experts" involved would be the test engineers and laboratory personnel performing the standard tests and interpreting the results against the predefined Pass/Fail criteria of those standards. Their qualifications would be expertise in materials science, microbiology, mechanical engineering, electrical engineering, and quality assurance, relevant to the specific tests performed.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "adjudication" is inherent in the Pass/Fail criteria defined by the consensus standards and the internal test methods. If a test yields a result outside the acceptable range, it fails. There's no subjective interpretation requiring an adjudication panel for these types of performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study applies to devices, often AI-powered, that assist human readers (e.g., radiologists) in diagnostic tasks. The TotalShield™ Surgical Helmet System is a physical barrier device for surgical personnel, not a diagnostic tool requiring human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The concept of "standalone performance" in the context of an algorithm without human-in-the-loop is not applicable to this device. The TotalShield™ Surgical Helmet System is a physical product designed for human use, not an algorithm. The performance tests conducted are intrinsically "standalone" in that they evaluate the physical properties and functional aspects of the device itself (e.g., the fan's airflow, the material's barrier properties) independent of a human's judgment or interaction beyond its intended use.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on objective measurements and predefined thresholds established by recognized consensus standards (e.g., AAMI/ANSI PB70 for liquid barrier performance, ASTM standards for material properties, ISO standards for sterilization and biocompatibility). The "ground truth" is whether the device's measured performance meets or exceeds the specifications outlined in these standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The testing involved physical prototypes or production samples of the device undergoing various performance tests.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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DEC 2 3 2013
200 West Ohio Avenue
ZIMBE
Summary of Safety and Effectiveness
| Sponsor: | Zimmer Surgical, Inc.200 West Ohio AvenueDover, OH 44622 |
|---|---|
| Contact Person: | Allison Scott, RACSenior ConsultantTelephone: (317) 569-9500 x106Fax: (317) 569-9520 |
| Date: | August 1, 2013 |
| Trade Name: | TotalShield™ Surgical Helmet System |
| Product Code / Device: | FYA - Surgical Gown |
| Regulation Number / Description: | 21 CFR § 878.4040 - Surgical Apparel |
| Predicate Device: | Microtek Medical Freedomaire III Surgical HelmetSystem Model 10322STK. K102971, cleared02/23/2011 |
| Device Description: | The TotalShield Zippered Surgical Toga and/orTotalShield Surgical Hood are used with theTotalShield Surgical Helmet and/or TotalShieldAdvanced Surgical Helmet with LED lighting as theTotalShield Surgical Helmet System to provide abarrier between the operating environment and thesurgical personnel in order to protect againstcontamination and/or exposure of infectious bodyfluids and harmful microorganisms.The TotalShield Surgical Helmet and AdvancedSurgical Helmet with LED lighting have a batterypowered fan, which provides a continuous flow ofair in the TotalShield Surgical Hood or ZipperedSurgical Toga.The TotalShield Surgical Hood is a stand-alonehead cover that may be worn with a separatesurgical gown, while the TotalShield ZipperedSurgical Toga is a one-piece head and body cover. |
| The stand-alone TotalShield Surgical Hood isidentical to the hood that is incorporated into theTotalShield Zippered Surgical Toga. TheTotalShield Surgical Hood or Zippered SurgicalToga must be worn over a TotalShield SurgicalHelmet or Advanced Surgical Helmet with LEDlighting. | |
| The TotalShield Zippered Surgical Toga has beentested to meet the applicable AAMI PB70 standardsfor level 3 compliance. The AAMI standard doesnot cover apparel for the head. face, and eyes.Therefore, the hoods and lens are exempt fromclassification under the AAMI PB70:2003 standard. | |
| Intended Use: | The TotalShield Zippered Surgical Toga and/orTotalShield Surgical Hood is for use with theTotalShield Surgical Helmet and/or TotalShieldAdvanced Surgical Helmet with LED lighting as theTotalShield Surgical Helmet System that is intendedto be worn by surgical personnel to provide abarrier between the operating environment and thesurgical personnel in order to protect againstcontamination and/or exposure of infectious bodyfluids and harmful microorganisms. |
| Technological Characteristics: | The TotalShield Surgical Helmet System issubstantially equivalent to other legally marketedsurgical apparel systems, specifically the MicrotekMedical Freedomaire III Surgical Helmet System inthat the devices have similar technologicalcharacteristics, including: |
| ● Has the same intended use, target populationand indications 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 samemode● Both are sterilized to SAL of 10-6● Reusable helmets are provided non-sterile● Is manufactured of similar materials | |
| Minor differences include:● Adjustable length on the Toga |
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- Slight dimensional differences ●
- . Optional LED lighting on Helmet
The minor differences do not affect the safety or effectiveness of the device and the TotalShield Surgical Helmet System is Substantially Equivalent to the predicate device.
| Property orCharacteristic | Proposed DeviceTotalShield Surgical Helmet System | Predicate:Freedomaire III, Surgical HelmetSystem |
|---|---|---|
| Intended Use/Indications forUse | The TotalShield Zippered Surgical Togaand/or TotalShield Surgical Hood is for usewith the TotalShield Surgical Helmet and/orTotalShield Advanced Surgical Helmet withLED lighting as the TotalShield SurgicalHelmet System that is intended to be wornby surgical personnel to provide a barrierbetween the operating environment and thesurgical personnel in order to protect againstcontamination and/or exposure of infectiousbody fluids and harmful microorganisms. | The Freedomaire III Surgical HelmetSystem is intended to be worn by surgicalpersonnel to provide a barrier betweenthe operating environment and thesurgical personnel in order to protectagainst contamination and/or exposure ofinfectious body fluids and harmfulmicroorganisms. |
| TargetPopulation | Operating room personnel | Operating room personnel |
Indications for Use
Technology & Product Features
| Property orCharacteristic | Proposed Device | Predicate |
|---|---|---|
| TotalShield Surgical Helmet System, | Freedomaire III Surgical HelmetSystem | |
| TotalShield Zippered Surgical Toga and Surgical Hood | ||
| Adjustable length(Toga) | Tear away feature at the bottom of the toga(outside of the critical zone) removes 12"from the length | Length is not adjustable |
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| Proposed Device | Predicate | |
|---|---|---|
| Property orCharacteristic | TotalShield Surgical Helmet System | Freedomaire III Surgical Helmetvstem |
| RecognizedConsensusStandards | Compliant at level 3Passed -AAMI/ANS1 PB70:2003/(R)2009Liquid barrier performance and classificationof protective apparel and drapes intended foruse in health care facilitiesPassed - ASTM F2407-06 StandardSpecification for Surgical Gowns Intendedfor Use in Healthcare Facilities | Compliant at level 3Passed -AAMI/ANSIPB70:2003/(R)2009 Liquid barrierperformance and classification ofprotective apparel and drapes intendedfor use in health care facilitiesPassed - ASTM F2407-06 StandardSpecification for Surgical GownsIntended for Use in Healthcare Facilities |
| SterilityAssurance Levelvia EOSterilization | 10-6 | 10- |
| Conditions of Use | Disposable/Single Use | Disposable/Single Use |
| Toga features a neck tie and waist tie | Toga features a neck tie and waist tie | |
| Closure Feature | Hood pulls over the head and does notrequire security | Hood pulls over the head and does notrequire security |
| Toga Sizes | Regular, Large, Extra Large | Regular, Large, Extra Large |
| Color | Blue | 0Blue |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED lighting | ||
| Method of HoodAttachment | Mechanical slot and hook-and-loop | Male features molded into faceshieldmate with female interface on helmet |
| Lighting Option | LED | None |
Materials
| Property orCharacteristic | Proposed Device | Predicate |
|---|---|---|
| TotalShield Surgical Helmet System | Freedomaire III Surgical Helmet System | |
| Toga and Hood | Nonwoven fabric | Nonwoven fabric |
| Lens/Face Shield | PETG clear copolyester | Clear polycarbonate |
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| Property orCharacteristic | Proposed DeviceTotalShield Surgical Helmet System | PredicateFreedomaire III Surgical Helmet-System |
|---|---|---|
| Filter | Blended Synthetic Fiber SpunboundPolypropylene | Blended Synthetic Fiber SpunboundPolypropylene |
| Helmet | Plastic | Plastic |
| LEDComponents | Aluminum, Stainless Steel | Not Applicable |
Performance Data Summary
| Proposed Device | Predicate | ||
|---|---|---|---|
| Property orCharacteristic | Testing Method | TotalShieldSurgical HelmetSystem | Freedomaire 111Surgical HelmetSystem |
| TotalShield Zippered Surgical Toga and Surgical Hood | |||
| Flammability ofClothing Textiles | ASTM F2100-07 reference 16 CFR-1610.4 | Class 1 Compliant-pass | Compliant |
| BiologicalEvaluation onSkin ContactingMaterial | ISO-10993-11 Acute Systemic Injection TestISO-10993-10 Intracutaneous Reactivity TestISO-10993-5 MEM Elution Assay with L-929Mouse Fibroblast CellsISO-10993-10 Guinea Pig MaximizationSensitization Test | Compliant- pass | Compliant |
| Sterility Method | ISO 11607-2 Packaging ValidationISO 11135-1 EO ValidationISO 10993-7 EO Residual Test | Compliant- pass | Compliant |
| Tear Resistance | ASTM D5733 MD Trap Tear | Compliant- pass | AAMI Level 3 |
| ASTM D5733 CD Grab Tensile Strength | Compliant- pass | AAMI Level 3 | |
| Tensile Strength | ASTM D5034 Grab Tensile Strength | Compliant- pass | AAMI Level 3 |
| Seam Strength | Test method ASTM D1683 | Compliant- passedseam test | AAMI Level 3 |
| Lint | ISO 9073; EN 13795-2 Test methods forsurgical drapes, gowns and clean air suits,used as medical devices for patients. clinicalstaff and equipment | Compliant- pass | AAMI Level 3 |
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| Property orCharacteristic | Testing Method | Proposed DeviceTotalShieldSurgical HelmetSystem | PredicateFreedomaire IIISurgical HelmetSystem. |
|---|---|---|---|
| Water VaporTransmissionRate | Test method ASTM D6701 | Compliant | AAMI Level 3 |
| Water resistance:ImpactpenetrationHydrostaticpressure | AAMI/ANSI PB70 | Compliant Level-3 | Compliant Level-3 |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED lighting | |||
| Airflow Testing | Internal Fan Performance Test Method | Passed AcceptanceCriteria | Passed AcceptanceCriteria |
| Helmet NoiseTesting | Internal Noise Measurement Test Method | Passed AcceptanceCriteria | Passed AcceptanceCriteria |
| Battery LifeTesting | Internal Battery Performance Test Method | Passed AcceptanceCriteria | Passed AcceptanceCriteria |
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Performance Data: Non-Clinical Performance:
During the development process of the TotalShield Surgical Helmet System. the following testing was completed:
Electrical safety and Environmental testing (IEC 60601-1 and IEC 60601-1-2)
Device Usability testing was conducted in accordance with requirements of IEC 60601-1-6 and IEC 62366:2007.
Sterilization Validation testing was conducted in accordance with AAMI/ANSI/ISO 11607-1, 11607-2 and AAMI/ANSI/ISO 11135-1. Shipping Validation was conducted according to ASTM D4169-09.
Biocompatibility Testing was conducted on skin contact material in accordance with ISO 10993-1. ISO 10993-10. ISO 10993-5 and ISO 10993-7.
Non-Clinical testing was conducted to demonstrate that the subject device performed as intended and met all acceptance criteria. including:
- . Airflow Testing
- . Helmet Noise Testing
- Battery Life Testing o
- . Liquid Barrier testing (per AAMI/ANSI PB70, for Surgical Zippered Toga only)
The TotalShield Surgical Helmet System adheres to the specifications for requirements for performance, documentation, and labeling per ASTM F2407-06.
Clinical Performance:
Conclusion:
Clinical data were not needed for this device.
All tests passed according to predetermined acceptance criteria, thus demonstrating equivalent performance of the subject device to the predicate device.
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Image /page/7/Picture/1 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with outstretched wings. The logo is black and white and appears to be a scan or photocopy of an official document or emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
Zimmer Surgical, Incorporated C/O Allison Scott, RAC Regulatory Affairs Consultant Navigant Consulting, Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268
Re: K132386
Trade/Device Name: TotalShield™ Surgical Helmet System Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: November 21, 2013 Received: November 22, 2013
Dear Ms. Scott:
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 - Ms. Scott
.. .. .. .. ..
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/ResourcesforYou/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.
Telashri Purohit-Sheth, M.D. Clinical Denuty Birector FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Sincerely yours,
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... .......................................................................................................................................................................... Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) KI32386
Device Name
Total Shield Surgical Heimet System
Indications for Use (Describe)
The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood is for use with the TotalSticled Surgical Helmer and/or TotalShield Advanced Surgical Helmer as TotalShield Surgical Helme: System that is intended to be worn by surgical personnel to provide a barrier between the surgical personnel in order to process against contamination and/or exposure of infectious body fluids and harmful microorganisms.
00990000100 TotalShield Surgicul Helmel (Non-sicrile. Reusable)
00999000200 TotalShield Advanced Surgical IIelmet with LED Lighting (Non-sterile, Reusable) 01990020000 TotalShield Six Bay Smart Batter Charger and Calibration System (Non-storile, Reassble) 0099002002 TotalShield Two Bay Smart Battery Charger and Calibration System (Non-sterile, Reusable) 00990010200 TotalShield Rechargeable Li-lon Battery (Non-sterile, Reusable)
00990010300 TotalShield Rochargeable Extended Life Li-Ion Bottery (Non-sterile. Revesble)
009900301 12 TotalShield Surgical Hood Sterile, EO Single Use
00990031210 TotalSliveld Zippered Sugical Toga AAMI Level 3 X-Large (Sterile (EO). Single Use)
0099003 ! ! 10 TotalShield Zippered Sugical Toga AAMI Level 3 (Sterite (EO), Single Use)
0099003 1010 TotalShield Zippercel Sugical Toga AAMI Level 3 (Sterile (EO), Single Use)
009900001306 TotalShield Surgical Helmer Rear Cranial Support (Non-sterile, Reusable)
110990010400 Total Shield Battery Holster (Non-sterile, Reusable)
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpert 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 Rediclogical Heatth (CDRH) (Signature)
Image /page/9/Picture/23 description: The image shows the name "Sreekanth Gutala -S" in large, bold font on the left side. On the right side, there is a digital signature block that reads "Digitally signed by Sreekanth Gutala -S". The signature block also includes information such as DN, OU, and a date and time stamp of 2013.12.23 13:08:42-05.
Gutala -S
Dit o US on U.S. Government 11-5 ounFDA, ou=People, 42.19200300.100.1.1=200054 0490, cnoSrockasth Gutala · S Date: 2013.12.23 13:08:42 -05'00
FORM FURCESSS(BAS) Inc.
K132388 Response to Reggest tof Bidttons! Information
-R-00046-26004, 111.4°N ET
§ 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.