(144 days)
Not Found
No
The device description and performance studies focus on physical barriers, airflow, battery life, and material properties, with no mention of AI or ML.
No
The description indicates the device provides a barrier to protect against contamination and exposure to infectious materials, which is a protective function, not a therapeutic one.
No
The device is a surgical helmet system intended to provide a barrier for protection against contamination and exposure to infectious body fluids and harmful microorganisms, not to diagnose a condition.
No
The device description clearly outlines physical components including a helmet, toga/hood, battery-powered fan, and LED lighting. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a physical barrier for surgical personnel to protect against contamination and exposure to infectious body fluids and microorganisms. This is a protective function, not a diagnostic one.
- Device Description: The description details a helmet system with a hood/toga that provides airflow and a barrier. It does not mention any components or functions related to testing samples from the human body to diagnose conditions.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly designed as personal protective equipment (PPE) for surgical staff.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical personnel / operating environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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:
Clinical data were not needed for this device.
Conclusion:
All tests passed according to predetermined acceptance criteria, thus demonstrating equivalent performance of the subject device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 2 3 2013
200 West Ohio Avenue
ZIMBE
Summary of Safety and Effectiveness
| Sponsor: | Zimmer Surgical, Inc.
200 West Ohio Avenue
Dover, OH 44622 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allison Scott, RAC
Senior Consultant
Telephone: (317) 569-9500 x106
Fax: (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 Helmet
System Model 10322STK. K102971, cleared
02/23/2011 |
| Device Description: | 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. |
| Intended Use: | 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. |
| Technological Characteristics: | The TotalShield Surgical Helmet System is
substantially equivalent to other legally marketed
surgical apparel systems, specifically the Microtek
Medical Freedomaire III Surgical Helmet System in
that the devices have similar technological
characteristics, including: |
| | ● Has the same intended use, target population
and indications for use as the predicate
● Uses the same operating principles
● Incorporates the same basic design of durable
helmet and single-use hoods and togas
● Hood and toga are sterilized using the same
mode
● 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 |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, and the word "zimmer" is written in lowercase letters below the circle. The "Z" in the circle is made up of two overlapping "Z" shapes, creating a bold and modern design.
.
・・
:
.
2
Image /page/2/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in lowercase letters.
- 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 or
Characteristic | Proposed Device
TotalShield Surgical Helmet System | Predicate:
Freedomaire III, Surgical Helmet
System |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | 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 Freedomaire III Surgical Helmet
System 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. |
| Target
Population | Operating room personnel | Operating room personnel |
Indications for Use
Technology & Product Features
| Property or
| Characteristic | Proposed Device | Predicate |
|---|---|---|
| TotalShield Surgical Helmet System, | Freedomaire III Surgical Helmet | |
| System | ||
| 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 |
3
Image /page/3/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in lowercase letters.
| Proposed Device | Predicate | |
|---|---|---|
| Property or | ||
| Characteristic | TotalShield Surgical Helmet System | Freedomaire III Surgical Helmet |
| vstem | ||
| Recognized | ||
| Consensus | ||
| Standards | Compliant at level 3 | |
| Passed -AAMI/ANS1 PB70:2003/(R)2009 | ||
| Liquid barrier performance and classification | ||
| of protective apparel and drapes intended for | ||
| use in health care facilities | ||
| Passed - ASTM F2407-06 Standard | ||
| Specification for Surgical Gowns Intended | ||
| for Use in Healthcare Facilities | Compliant at level 3 | |
| Passed -AAMI/ANSI | ||
| PB70:2003/(R)2009 Liquid barrier | ||
| performance and classification of | ||
| protective apparel and drapes intended | ||
| for use in health care facilities | ||
| Passed - ASTM F2407-06 Standard | ||
| Specification for Surgical Gowns | ||
| Intended for Use in Healthcare Facilities | ||
| Sterility | ||
| Assurance Level | ||
| via EO | ||
| Sterilization | 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 not | |
| require security | Hood pulls over the head and does not | |
| require security | ||
| Toga Sizes | Regular, Large, Extra Large | Regular, Large, Extra Large |
| Color | Blue | 0 |
| Blue | ||
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED lighting | ||
| Method of Hood | ||
| Attachment | Mechanical slot and hook-and-loop | Male features molded into faceshield |
| mate with female interface on helmet | ||
| Lighting Option | LED | None |
Materials
| Property or
| Characteristic | 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 |
4
Image /page/4/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font.
| Property or
Characteristic | Proposed Device
TotalShield Surgical Helmet System | Predicate
Freedomaire III Surgical Helmet-System |
|-------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| Filter | Blended Synthetic Fiber Spunbound
Polypropylene | Blended Synthetic Fiber Spunbound
Polypropylene |
| Helmet | Plastic | Plastic |
| LED
Components | Aluminum, Stainless Steel | Not Applicable |
Performance Data Summary
| Proposed Device | Predicate | ||
|---|---|---|---|
| Property or | |||
| Characteristic | Testing Method | TotalShield | |
| Surgical Helmet | |||
| System | Freedomaire 111 | ||
| Surgical Helmet | |||
| System | |||
| TotalShield Zippered 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 Test | ||
| ISO-10993-10 Intracutaneous Reactivity Test | |||
| ISO-10993-5 MEM Elution Assay with L-929 | |||
| Mouse Fibroblast Cells | |||
| ISO-10993-10 Guinea Pig Maximization | |||
| Sensitization Test | Compliant- pass | Compliant | |
| Sterility Method | ISO 11607-2 Packaging Validation | ||
| ISO 11135-1 EO Validation | |||
| ISO 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- passed | |
| seam test | AAMI Level 3 | ||
| Lint | ISO 9073; EN 13795-2 Test methods for | ||
| surgical drapes, gowns and clean air suits, | |||
| used as medical devices for patients. clinical | |||
| staff and equipment | Compliant- pass | AAMI Level 3 |
5
Image /page/5/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font.
| Property or
Characteristic | Testing Method | Proposed Device
TotalShield
Surgical Helmet
System | Predicate
Freedomaire III
Surgical Helmet
System. |
|----------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------|
| Water Vapor
Transmission
Rate | Test method ASTM D6701 | Compliant | AAMI Level 3 |
| Water resistance:
Impact
penetration
Hydrostatic
pressure | 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 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 |
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
Image /page/6/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in lowercase letters.
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.
7
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.
8
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,
9
... .......................................................................................................................................................................... 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