GREENCROSS SURGICAL MASK

K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · FXX · Jul 17, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123787
• Device Name: GREENCROSS SURGICAL MASK
• Applicant: Jingzhou Haixin Green Cross Medical Products Co.,L
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The GreenCross Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism. body fluid, and particulate aerosol transfer.

Device Story

GreenCross Surgical Mask is a 3-ply, flat-pleated, single-use mask. Construction includes inner and outer layers of 100% spun-bond polypropylene and a middle layer of 100% meltblown polypropylene filter media. Features include latex-free elastic ear-loops or tie-on straps and a plastic wire nose piece. Used in clinical settings by healthcare workers and patients to provide a physical barrier against microorganisms, body fluids, and particulate aerosols. Device is non-sterile and intended for single use.

Clinical Evidence

Bench testing only. Performance evaluated via ASTM F2101 (BFE: 99.8%), ASTM F2299 (PFFE: 99.1%), ASTM F1862 (Fluid Resistance: 29/32 pass at 120 mm Hg), MIL-M-36945C (Delta-P: 2.6-2.9 mm H2O/cm²), 16 CFR 1610 (Flammability: Class 1), and ISO 10993 (Biocompatibility).

Technological Characteristics

3-ply flat-pleated mask. Materials: 100% spun-bond polypropylene (inner/outer), 100% meltblown polypropylene (filter). Plastic wire nose piece. Latex-free elastic ear-loops or tie-on straps. Dimensions: 175±5 mm x 90±5 mm. Biocompatible per ISO 10993.

Indications for Use

Indicated for health care workers and patients as a protective nose and mouth covering during medical and surgical procedures where there is a risk of exposure to microorganisms, body fluids, and particulate aerosols.

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

• Surgical Mask (For Single Use Only) by Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd (K101000)

Submission Summary (Full Text)

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K123787

# Section 2: 510(k) Summary:

# JUL 1 7 2013

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

### Submitter & Foreign Manufacture Identification

Jingzhou Haixin Green Cross Medical Products Co., Ltd Century Building 19F A. Jianghan RD 206 Wuhan City, Hubei 430010, P. R, China Contact person: Bill Liao Tel: [phone]

### Submitter's FDA Registration Number: N/A

### US Agent and Contact Person 1.

Xiangyang Song 6 Vanderblet Road, Acton, MA, 01720 Tel: [phone] Email: [e-mail]

Date of Summary: December 03, 2012, Date of Revision 1: December 26, 2012, Date of Revision 2: May 17, 2013

### 2. Regulatory Information

Name of Device: GreenCross Surgical Mask Model No.: GFM12 Type: Tie-on, Earloop Common Name: Surgical Mask Panel: General & Plastic Surgery Device Classification: Class II Regulation Number: 878.4040 Product Code: FXX Classification Name: Mask, Surgical

### Predicate Device Information: 3.

K101000: Surgical Mask (For Single Use Only) by Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd

#### Device description: 4.

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GreenCross surgical masks, Type: Earloop or Tie-on, are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. All of the materials used in the construction of the GreenCross surgical masks are being used in currently marketed devices, except the nose piece used plastic wire instead of aluminum wire. (see predicate information)

### Intended Use: ડ.

The GreenCross Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism. body fluid, and particulate aerosol transfer.

### 6. Comparison to Predicate Devices

GreenCross Surgical Mask is compared with its Predicate devices: K101000: Surgical Mask (For Single Use Only) by Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd. The design, material, and other technical characteristics of these two devices are very similar, except that the nose piece for GreeCross Surgical Mask used plastic wire instead of aluminum wire, also the size, color & design type (Ear Loop or Tie-on) are different to predicate device. These features are not expected to affect the safety and performance of the device.

| Description | Our Device | Predicate Device (K101000) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | Nose and mouth covering for health<br>care workers and patients to prevent<br>microorganism, body fluid, and<br>particulate aerosol transfer. | Same |
| Layers | Three | Three |
| Materials | Outer layer is made of 100% spun-<br>bond polypropylene.<br>Middle player is made of 100%<br>meltblown polypropylene filter<br>media.<br>Inner layer is made of 100% spun-<br>bond polypropylene.<br>Ear-loops are made of soft latex free<br>elastic loops.<br>The nose piece is plastic wire | Outer layer is made of 100% spun-<br>bond polypropylene.<br>Middle player is made of 100%<br>meltblown polypropylene filter<br>media.<br>Inner layer is made of 100% spun-<br>bond polypropylene.<br>Ear-loops are made of soft elastic<br>loops.<br>The nose piece is malleable<br>aluminum wire |

### Comparison of Intended Use, Design, Material and Specifications

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| Dimensions | 175±5 mm x90±5 mm | Large: 180x90mm, Medium:<br>175 x95mm, Small: 145x90 mm |
|------------------------|-------------------|---------------------------------------------------------|
| Mask style | Flat Pleated | Flat Pleated |
| Design | EarLoop, Tie-on | EarLoop |
| Anti Fog<br>Shield | N/A | N/A |
| Color | white | Blue |
| NIOSH<br>certification | N/A | N/A |

## Comparison of Device Performance

| Test | Our Device | Predicate Device (K101000) |
|----------------------------------------------------|-----------------------------------|----------------------------|
| Fluid Resistance<br>Performance<br>ASTM F1862 | 29 out of 32 pass<br>at 120 mm Hg | 31 out of 32 pass |
| Particle Filtration<br>Efficiency<br>ASTM F2299 | 99.1% | 99.8% |
| Bacteria Filtration<br>Efficiency<br>ASTM F2101 | 99.8% | 99.9% |
| Differential Pressure<br>(Delta-P)<br>MIL-M-36945C | 2.6-2.9<br>(mm Water/cm²) | 3.7-4.0<br>(mm Water/cm²) |
| Flammability<br>16CFR 1610 | Class 1 None Flammable | Class 1 None Flammable |
| Biocompatibility<br>ISO 10993-5, -10 | Biocompatible | Biocompatible |

#### 7. Discussion of Non-Clinical Tests Performed to Determine Substantial Equivalence

The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the following standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.

- (1) ASTM F2101 Bacterial Filtration Efficiency (BFE)
- Pressure Differential (Delta P) MIL-M-36945C Cl. MIL-M-36945C (2) 4.4.1.1.1
- ASTM F2299 Latex Particle Challenge (PFFE) (3)
- 16 CFR Part 1610 Flammability (4)
- Biocompatibility per ISO 10993 (5)

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- (6) ASTM F1862 Fluid Resistant - Synthetic Blood Penetration Resistant Test
It is our conclusion that performance testing met all relevant requirements of the above said test standards. More detail comparison of the design, technical, and performance characteristics to the predicted device are summarized in "510(k) Premarket Notification for Jingzhou Haixin Surgical Mask" chapter 4 summary report, section 4.1 to 4.4. More details of non-clinical tests are summarized in Chapter 4, section 4.5 and 4.6

### Discussion of Clinical Tests Performed 8. Not applicable

#### 9. Conclusions

.

The GreenCross surgical mask has the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission demonstrates that the technological characteristics of GreenCross Surgical masks do not raise any new questions of safety or effectiveness. Therefore, GreenCross surgical masks By Jingzhou Haixin Green Cross Medical Products Co., Ltd are substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### July 17, 2013

Jingzhou Haixin Green Cross Medical Products Company, Limited C/O Mr. Xiangyang Song 6 Vanderbelt Road ACTON MA 01720

Re: K123787

Trade/Device Name: GreenCross Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 16, 2013 Received: June 14, 2013

Dear Mr. Song:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Song

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division 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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K123787

## Section 1: Indication for Use Statement

## Device name: GreenCross Surgical Mask

The GreenCross Surgical Masks are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

Prescription Use

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Elizabeth F. Claverie
2013.07.16 18:50:22 -04'00'

(Division Sign-Off) (Division of Anesthestology, General Hospital n Control, Dental I

**510(k) Number:** K123787

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