SHANGHAI GANGHAI MODEL GIKO 1400

K063334 · Shanghai Gangkai Purifying Products Co., Ltd. · MSH · Dec 8, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063334
• Device Name: SHANGHAI GANGHAI MODEL GIKO 1400
• Applicant: Shanghai Gangkai Purifying Products Co., Ltd.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is 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. This device also meets CDC Guidelines for TB Exposure Control.

Device Story

Duckbill-style N95 respirator and surgical mask; constructed of nonwoven inner/outer shells with polypropylene melt-blown filter media; features elastic rubber headband, closed-cell foam nosepiece, and plastic-coated aluminum nosepiece. Used in operating rooms by surgical personnel; provides barrier protection against microorganisms, body fluids, and particulates. NIOSH-approved (TC-84A-4282) for 95% filtration efficiency against 0.3-micron particles. Protects both patient and wearer; aids in TB exposure control. Does not eliminate disease transmission risk; requires immediate replacement if contaminated.

Clinical Evidence

Bench testing only. Device passed NIOSH certification (TC-84A-4282) for 95% filtration efficiency at 0.3 microns. Fluid resistance tested per ASTM F1862-00. Flammability tested per 16 CFR Part 1610. Biocompatibility verified via cytotoxicity, agar overlay, and Buehler sensitization methods.

Technological Characteristics

Duckbill-style N95 respirator. Materials: nonwoven inner/outer shells, polypropylene melt-blown filter, elastic rubber headband, closed-cell foam, plastic-coated aluminum nosepiece. Dimensions: 0.038-inch thickness, 27 sq. in. surface area. NIOSH-approved per 42 CFR 84. Fluid resistance per ASTM F1862-00. Flammability per 16 CFR 1610.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect patients and staff from microorganisms, body fluids, and particulate material. Also indicated for TB exposure control per CDC guidelines. Single-use, disposable, latex-free, non-sterile, non-fiberglass mask.

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

• Gerson Model 2130 Type N95 Mask (K050193)

Submission Summary (Full Text)

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510(K) Summary

KOC3334

Submitter Joseph Z. Zdrok & Associates 7380 36 TH Court Vero Beach, FL. 32967

DEC - 8 2006

Contact Joseph Z. Zdrok President 772-778-0240 Telephone [phone] FAX [e-mail] E-Mail

Nov.6, 2006 Date

Trade Name

Shanghai Ganghai Purifying Products Co. Ltd. Type N-95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400

Common Name: Healthcare Particulate Respirator and Surgical Mask

Classification Device Class - Class II CFR Section - 21 CFR 878.4040

Substantial Equivalency:

The Model GIKO 1400 Heathcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to the Gerson Model 2130 Type N95 Mask . (510(K) No. K050193. Both products have been tested and approved by NIOSH as N-95 respirators.

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#### USE

#### Description:

The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is of a duckbill style. It constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is lavered between the inner and outer shell. The headband is made of elastic rubber . The inside nosepiece utilizes a closed cell foam and the outside nosephere which conforms to the nose is made of plastic coated aluminum.

#### Description of Device Requirements

The Shanghai Ganghai Type N95 Healthcare Respirator and Surgical Mask Model GIKO !400 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-4282 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is resistant to synthetic blood as per ASTMF1862-00 Standard Test Method for Resistance of Medical Face Mask to Penetration by Synthetic Blood, conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9. Flammability testing as per16CFR Part1610 was conducted by Nelson Laboratories.

#### Intended Use:

The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is 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.

This device also meets CDC Guidelines for TB Exposure Control.

## Limitations:

This product does not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.

### Comparison of Predicate Device

The outside cover stock color of the previously cleared device is white. The Shanghai Ganghai Model GIKO 1400 Healthcare Particulate Respirator and Surgical Mask Model is also white. The headband color of the cleared device is yellow and the Shanghai Ganghai Model GIKO 1400 is white.

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The Shanghai Ganghai Model GIKO 1400 Healthcare Particulate Respirator and Surgical Mask incorporates a highly efficient filter media and is 95% efficient against a .3 micron particulate which was scientifically established as the most penetrating particle size. The legally marketed Gerson device previously cleared 510 (k) K050193 NIOSH T C -84A-4123 is manufactured from similar materials.

#### Risks to Health

The FDA Guidance Document was used to identify the risks to health associated with the use of surgical masks. The device was tested as per the mitigation measures listed below.

| Identified Risk | Mitigation Measures |
|-----------------------------------------------------------|----------------------------------------------------------|
| Inadequate fluid resistance | ASTM F1862 |
| Inadequate barrier for bacteria | NIOSH TC-84A-4282 |
| Inadequate air exchange | NIOSH TC-84A-4282 |
| Flammability | 16CFR Part 1910 |
| Biocompatibility for patient/user<br>contacting materials | Cytotoxicity Agar Overly Sensitization<br>Buehler Method |

#### Safety/Effectiveness

The device has a filtration equivalent to the previously cleared Gerson 2130 Healthcare Particulate Respirator and Surgical Mask Respirator. It is NIOSH approved and meets the CDC guidelines for TB Exposure Control. The GIKO 1400 was subjected to the tests listed and passed.

#### Conclusion:

Since the basic construction is used in the FDA cleared device as in the new device and approved by NIOSH, the GIKO 1400 Shanghai Ganghai Healthcare Particulate Respirator and Surgical Mask is substantially equivalent to the Gerson Model 2130 Healthcare and Particulate Respirator and Surgical Mask

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# Physical Characteristics

## MATERIALS

| Part | GIKO 1400 | Gerson2130 |
|-------------------|-------------------------|--------------------------|
| Inside Shell | Nonwoven | Nonwoven |
| Filter | Nonwoven | Nonwoven |
| Outside Shell | Nonwoven (White) | Nonwoven (White) |
| Headband | Elastic (White) | SyntheticRubber (Yellow) |
| Inside Nosepiece | Closed Cell Foam | Closed Cell Foam |
| Outside Nosepiece | Plastic Coated Aluminum | Plastic Coated Aluminum |

## Physical Measurements

| Physical Attributes | GIKO 1400 | Gerson 2130 |
|---------------------|-------------------------------------|-------------------------|
| Mask Thickness | 0.038 Inches | 0.037 Inches |
| Surface Area | 27.0 Square inches | 27.0 Square inches |
| Headband Length | 24 Inches Total Continuous<br>Loop | 12 Long 10 Short Inches |
| Facepiece Length | 7.0 Inches | 7.0 Inches |

# Mask Style

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

Shanghai Gangkai Purifying Products Corporation, Limited C/O Mr. Joseph Z. Zdrok Consultant 7380 36th Court Vero Beach, Florida 32967

Re: K063334

Trade/Device Name: Shanghai Ganghai Type N95 Model GIKO 1400 Healthcare Particulate Respirator and Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: November 28, 2006 Received: November 29, 2006

Dear Mr. Zdrok:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Zdrok

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Syuta Y. Mohani Dmd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**M**anchester **U**nited

Indications for Use 51 16k) Number (if known): K 06834 Anghat Type Not Choose ( Device Name . Indications for I is he Shanghai Garghis Model GIKO HOO HEALTheARe PARTicuLate Respirator And SURGICAL MASK is A NIOSA AppRoved NAS Single use, disposable, LATEX FRE NON-steriLe product. It is A NON-Fiberghass, ALuid Resistant MASK intended To be worn by operating Room personnel during surgical procedures to protect both the surgical patient and t operating room personnel from TRANSACR of HICROORDANISMS DODY ALLINGS AND PARTICULATE Interial . This device ALso meets CDC Guidelines for TB Exposure Control .

Prescription Use (Pari 21 CFR 801 Subpart D)

AND/OR

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

Anas Glesiology, General Hospital

I Control, Dental Devices

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Concurrence of CDRH, Office of Device Evaluation (ODE

Hill

http://www.fda.gov/cdrh/ode/INDICATE HTML