Insta-Gard Surgical and Procedure Face Mask

K142990 · Cardinal Health200, LLC · FXX · Mar 4, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142990
• Device Name: Insta-Gard Surgical and Procedure Face Mask
• Applicant: Cardinal Health200, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

Device Story

Insta-Gard surgical and procedure masks; three-layer nonwoven construction; sonically welded edges; includes polyolefin ties or polyester-spandex earloops; malleable nosepiece for fit; optional eye shield; anti-fog foam strips; vapor barriers. Used in operating rooms and clinical settings by healthcare personnel. Single-use, disposable, non-sterile. Provides physical barrier against microorganisms, blood, body fluids, and airborne particulates. Protects both patient and wearer.

Clinical Evidence

Bench testing only. Device tested in accordance with ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks. All models met Level 1 criteria. Testing performed at an AQL of 4% (32 samples tested).

Technological Characteristics

Three-layer construction; materials include nonwoven tissue, cellulose, and polyolefin; sonically welded; includes polyolefin ties or polyester-spandex earloops; malleable nosepiece; optional anti-fog foam strip, vapor barrier, and eye shield. Tested to ASTM F2100-11 Level 1. Non-sterile.

Indications for Use

Indicated for operating room personnel and general healthcare workers to protect patients and wearers from microorganisms, blood, body fluids, and airborne particulates.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Kimberly-Clark, KC100 Face Mask(s) (K110455)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract 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

March 4, 2015

Cardinal Health 200, LLC Ms. Lavenia Ford Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K142990

Trade/Device Name: Cardinal Health Insta-Gard® Surgical and Procedure Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 4, 2015 Received: February 5, 2015

Dear Ms. Ford:

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.

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K142990

#### Device Name

Cardinal Health Insta-Gard® surgical and procedure masks

Indications for Use (Describe)

Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table I below. Each model is a three-laver mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.

Table 1: Product Description and Catalog Number

Catalog # Description, Color

AT771145 Insta-Gard® surgical mask Ties Dancing Bandages Print AT71235 Insta-Gard® surgical mask Anti-fog foam strip, and tiesBlue AT71035 Insta-Gard® surgical mask ties Blue AT71039 Insta-Gard@ surgical mask Horizontal ties Blue AT73035Insta-Gard® surgical maskTiesWhite AT752007 Insta-Gard® surgical mask Anti-fog foam strip, vapor barrier, and ties Green AT752005 Insta-Gard® surgical mask Anti-fog foam strip, vapor barrier, and ties Green AT73835 Insta-Gard® surgical mask Anti-fog foam strip, and ties Green AT72835 Insta-Gard® surgical mask Anti-fog foam strip, and ties Green AT7505P Insta-Gard® surgical mask Ties Blue AT73335 Insta-Gard® surgical mask Ties White AT71021 Insta-Gard® procedure mask Earloops Blue AT70021 Insta-Gard® procedure mask Earloops Yellow AT7511-WE Insta-Gard® procedure mask Eye shield, anti-fog foam strip, and earloops Blue AT771141 Insta-Gard® procedure mask Earloops Dancing Bandages Print

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

#### 1500 Waukegan Road Waukegan, IL 60085

www.cardinalhealth.com

### 510(k) SUMMARY Insta-Gard® Surgical and Procedure Masks

Manufacturer:

Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085

1500 Waukegan Road

Lavenia Ford

[phone]

December 31, 2014

Regulatory Affairs Contact:

Waukegan, IL 60085

Telephone Number:

Fax Number: [phone]

Date summary Prepared:

Trade Name:

Insta-Gard® Surgical Mask
Insta-Gard® Procedure Mask

Regulation Number/Device Class: Class II per 21 CFR § 878.4040

FXX

Surgical Apparel Regulation Name:

Common Name:

Surgical Mask Procedure Mask

Product Code:

K110455 -Kimberly-Clark, KC100 Face Mask(s)

Predicate Device:

{4}------------------------------------------------

# Description

The Cardinal Health Insta-Gard surgical and procedure masks are identified by Regulation 21 CFR 878.4040 with product code FXX.

The Cardinal Health Insta-Gard® surgical and procedure masks are constructed of varying materials (see Table 3). The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile.

### Indications for Use

Cardinal Health Insta-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table 1 below. Each model is a three-layer mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.

| Catalog # | Trade Name | Design Features | Color |
|-----------|----------------------------|--------------------------------------------------|---------------------------|
| AT771145 | Insta-Gard® surgical mask | Ties | Dancing<br>Bandages Print |
| AT71235 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Blue |
| AT71035 | Insta-Gard® surgical mask | ties | Blue |
| AT71039 | Insta-Gard® surgical mask | Horizontal ties | Blue |
| AT73035 | Insta-Gard® surgical mask | Ties | White |
| AT752007 | Insta-Gard® surgical mask | Anti-fog foam strip, vapor<br>barrier, and ties | Green |
| AT752005 | Insta-Gard® surgical mask | Anti-fog foam strip, vapor<br>barrier, and ties | Green |
| AT73835 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Green |
| AT72835 | Insta-Gard® surgical mask | Anti-fog foam strip, and ties | Green |
| AT7505P | Insta-Gard® surgical mask | Ties | Blue |
| AT73335 | Insta-Gard® surgical mask | Ties | White |
| AT71021 | Insta-Gard® procedure mask | Earloops | Blue |
| AT70021 | Insta-Gard® procedure mask | Earloops | Yellow |
| AT7511-WE | Insta-Gard® procedure mask | Eye shield, anti-fog foam strip,<br>and earloops | Blue |
| AT771141 | Insta-Gard® procedure mask | Earloops | Dancing<br>Bandages Print |

#### Table 1: Product Description and Catalog Number

{5}------------------------------------------------

# Device and Predicate Device Technical Characteristics

The Cardinal Health Insta-Gard® surgical and procedure masks are substantially equivalent to the Kimberly Clark surgical and procedure mask with regards to claims, safety and effectiveness, design, technology, and intended use. See Table 4 below.

| Table 4: Comparison of Predicate device and Cardinal Health Insta-Gard® Surgical and<br>Procedure Masks | | |
|---------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------|
| Element of Comparison | Kimberly-Clark (KC100) | Cardinal Health Insta-Gard®<br>Surgical and Procedure Masks |

| Element of Comparison | Kimberly-Clark (KC100) | Cardinal Health Insta-Gard Surgical and Procedure Masks |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Kimberly Clark KC100 Face<br>Mask(s) is intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material.<br>These face masks are intended<br>for use in infection control<br>practices to reduce the potential<br>exposure of the wearer to blood<br>and body fluids. The Kimberly<br>Clark KC100 face mask(s) is a<br>single use, disposable device(s),<br>provided non-sterile. | Insta-Gard® Surgical Mask<br>Cardinal Health Insta-Gard®<br>surgical masks are intended to<br>be worn by operating room<br>personnel and other general<br>healthcare workers to protect<br>both patients and healthcare<br>workers against transfer of<br>microorganisms, blood and body<br>fluids, and airborne particulates.<br>The Cardinal Health Insta-Gard®<br>surgical masks are single use,<br>disposable devices provided non-<br>sterile.<br><br>Insta-Gard® Procedure Mask<br>Cardinal Health Insta-Gard®<br>procedure masks are intended to<br>be worn by operating room<br>personnel and other general<br>healthcare workers to protect<br>both patients and healthcare<br>workers against transfer of<br>microorganisms, blood and body<br>fluids, and airborne particulates.<br>The Cardinal Health Insta-Gard®<br>procedure masks are single use,<br>disposable devices provided non-<br>sterile |
| Material Composition | 3 layer mask made from<br>nonwoven polyester blends,<br>tissue, cellulose, and<br>polypropylene materials | Insta-Gard® Surgical Mask<br>3 layer mask made from<br>nonwoven tissue, cellulose, and<br>polyolefin materials<br>Insta-Gard® Procedure Mask<br>3 layer mask made from<br>nonwoven tissue, cellulose, and<br>polyolefin materials |
| Specifications and Dimensions | KC100 Surgical Mask<br>6.875"x3.75"<br><br>KC100 Procedure Mask<br>6.9"x4.5" | Insta-Gard® Surgical Mask<br>AT771145 – 7"x4"<br>AT71235 – 7"x4"<br>AT71035 – 7"x4"<br>AT71039 – 7.5"x7.5"<br>AT73035 |

{6}------------------------------------------------

| | | | AT752007 – 7"x4"<br>AT752005 – 7"x4"<br>AT73835 – 7"x4"<br>AT72835 – 7"x4"<br>AT7505P – 7"x4"<br>AT73335 – 7"x4" | |
|------------------|--|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Insta-Gard® Procedure Mask<br>AT7511-WE – 7"x3.375"<br>AT771141 – 7"x3.375"<br>AT71021 – 7"x3.375"<br>AT70021 – 7"x3.375" | |
| | | | See Appendix I for mask<br>specifications | |
| Mask Style | | Pleated | Insta-Gard® Surgical Mask<br>Pleated<br>Insta-Gard® Procedure Mask<br>Pleated | |
| Design Features | | KC100 Surgical Mask<br>Fog-Free | Insta-Gard® Surgical Mask<br>AT771145 – Ties<br>AT71235 – Anti-fog foam strip<br>and Ties<br>AT71035 – Ties<br>AT71039 – Horizontal Ties<br>AT73035 – Ties<br>AT752007 – Anti-fog foam strip,<br>Vapor barrier, and Ties | |
| | | KC100 Procedure Mask<br>Fog-Free | AT752005 – Anti-fog foam strip,<br>Vapor barrier, and Ties<br>AT73835 – Anti-fog foam strip<br>and Ties<br>AT72835 – Anti-fog foam strip<br>and Ties<br>AT7505P – Ties<br>AT73335 – Ties | |
| | | | Insta-Gard® Procedure Mask<br>AT7511-WE – Eye shield, Anti-<br>foam fog strip, and Earloops<br>AT771141 – Earloops<br>AT71021 – Earloops<br>AT70021 – Earloops | |
| Physical Testing | | | Predicate device was tested<br>according to ASTM F2100-11<br>Level 1 in previous 510(k)<br>submission K110455. | Insta-Gard® Surgical Mask<br>Device was tested in accordance<br>with ASTM F2100-11, and meets<br>Level 1 requirements.<br>Insta-Gard® Procedure Mask<br>Device was tested in accordance<br>with ASTM F2100-11, and meets<br>Level 1 requirements. |

. . . .

{7}------------------------------------------------

All results of testing met ASTM F2100-11 Level 1 acceptance criteria. ASTM F2100-11 Level 1 was performed at an AQL of 4% (32 samples tested, accept on 3 failures and reject on 4 failures).

# Conclusion Statement

The Insta-Gard® surgical and procedure masks are substantially equivalent to the predicate device, in terms of general intended use performance testing, material composition, configurations/dimensions, and safety and effectiveness.