Pasture 60S Surgical Mask

K141875 · Pasture Pharma Pte, Ltd. · FXX · May 5, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141875
• Device Name: Pasture 60S Surgical Mask
• Applicant: Pasture Pharma Pte, Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Story

Pasture 60S Surgical Mask is a flat-pleated, 4-layer disposable surgical mask; constructed from polypropylene and meltblown filter media; features synthetic elastic ear loops and a nosepiece made of zinc wires embedded in polyester. Used by healthcare personnel in clinical settings during procedures to provide a barrier against microorganisms, body fluids, and particulate material. Protects both patient and wearer. Device is non-sterile and intended for single use.

Clinical Evidence

Bench testing only. Performance data includes: Fluid Resistance (120 mmHg), Particulate Filtration Efficiency (99.4%), Bacterial Filtration Efficiency (99.76%), Differential Pressure (3.33 mmH2O/cm2), and Flammability (Class 1). Biocompatibility testing confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

4-layer flat-pleated mask; materials: polypropylene, meltblown filter media, zinc wire/polyester nosepiece, synthetic elastic ear loops. Non-sterile, single-use. Dimensions: 184x144 mm.

Indications for Use

Indicated for healthcare personnel during procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material.

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

• TIDI® Facemasks (K092580)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2015

Pasture Pharma Pte. Ltd Mrs. Sarah Hassan US Med Pharm Supplies, Inc. 38129 Spring Canyon Drive Murrieta, CA 92563

Re: K141875

> Trade/Device Name: Pasture 60S Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: March 24, 2015 Received: April 3, 2015

Dear Ms. Hassan.

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 - Mrs. Hassan

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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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# Indications for Use

510(k) Number (if known) K141875

Device Name Pasture 60S Surgical Mask

Indications for Use (Describe)

Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92(c)

The assigned 510(k) number is: K141875

### Manufacturer:

CHAMPAK ENTERPRISE CO., LTD. 27-1, Jhaiming St., Dasi Township, Taoyuan County, 335, Taiwan (R.O.C.)

# Official Correspondent:

Lloyd Soong President & CEO Pasture Pharma Pte, Ltd 8 Boon Lay Way #04-01 Trade Hub 21, Singapore 609964

## US agent and correspondent:

Mrs. Sarah Hassan US Med Pharm Supplies, Inc 38129 Spring Canyon Drive Murrieta, CA 92563 Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Date of Submission:

May 1, 2015

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## Classification name:

Surgical Apparel

## Proprietary Name:

Pasture 60S Surgical Mask

## Device Classification and Product Code

Classification Name: Surgical Mask (21 CFR §878.4040) Class: Class II Classification panel: General and Plastic Surgery Product Code: FXX

## Common name:

Surgical Mask

## Regulatory Reference:

21 CFR 878.4040

## Predicate Device:

TIDI PRODUCTS, LLC TIDI® Facemasks K092580

### Labels/ Labeling:

Pasture 60S Surgical Mask will be marketed as single use disposable surgical mask for the Intended Use purpose below.

### Intended Use:

Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material

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# Device Description:

Pasture 60S Surgical Mask is a flat pleated surgical mask. It is in 4 layers and composed of PP and Meltblown, also with elastic loops and nosepiece which is the combination of zinc wires and embedded polyester inside of layers.

# Comparison to Predicated Devices:

The subject device is substantially equivalent to TIDI® Facemasks cleared under K092580.

| Description | Predicate<br>K092580 TIDI®<br>Facemasks | Pasture 60S Surgical<br>Mask |
|-----------------|-----------------------------------------------------------------|-----------------------------------------------------------|
| Outer layer | Polypropylene | Polypropylene |
| Filter Media | Melt-blown | Meltblown |
| Inner layer | Polypropylene | Polypropylene |
| Nose Piece | Aluminum | Combination of zinc wires<br>and embedded polyester |
| Ear Attachment | Elastic | Synthetic elastic |
| Mask style | Flat Pleated | Flat Pleated |
| Design features | 3 layers of non-woven<br>fiber with filter web in the<br>middle | 4 layers of non-woven<br>fiber containing a filter<br>web |

| Test | K092580 | Pasture 60S Surgical Mask |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance Performance | Pass@80mmHg | Pass@120mmHg |
| (mmHg) | | |
| Particulate Filtration | 99.6 | 99.4 |
| Efficiency Performance (%) | | |
| Bacterial Filtration Efficiency | >99.9 | 99.76 |
| Performance (%) | | |
| Differential Pressure<br>(Delta-P) (mmH2O/ cm2) | 3.4 | 3.33 |
| Flammability Class 1 | Class 1 | Class 1 |
| Sterile | Non-sterile<br>Single use | Non-sterile<br>Single use |
| Size | 7.0 x 3.5 inches | $184\pm1$ x $144\pm1$ mm |
| Indication for Use | Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material. | Pasture 60S Surgical Mask is a surgical mask indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. |
| Biocompatibility Test | Not available<br>Not available<br>Not available | Cytotoxicity: non-cytotoxic<br>Sensitization: non-sensitizing<br>Primary skin irritation: non-irritating |

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## Performance Tests:

#### Test Performed Laboratory

#### 1. Biocompatibility test: SUPER LABORATORY SGS (TAIWAN) LTD

- 2. Flammability test : Taiwan Textile Research Institute
- 3. Synthetic Blood Penetration test : Taiwan Textile Research Institute
- 4. Particulate Filtration Efficiency : Nelson Laboratories
- 5. Bacterial filtration efficiency: Taiwan Textile Research Institute
- 6. Differential pressure testing: Taiwan Textile Research Institute

## Conclusions:

The test data submitted in this submission demonstrate that the subject device is as safe and as effective as the predicate and technological characteristics do not raise any new questions of safety and as effectiveness. Pasture 60S Surgical Mask is substantially equivalent to the predicate cleared in K092580.