(32 days)
Not Found
No
The device description and performance studies focus on the physical construction and filtration capabilities of a respirator mask, with no mention of AI or ML.
No
This device is a particulate respirator and surgical mask intended to prevent the transfer of microorganisms, not to treat a medical condition.
No
The device is a particulate respirator and surgical mask, designed to protect individuals from transferring microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines a physical product (mask) made of various materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a respirator and surgical mask designed to protect individuals from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of a mask, not a device that analyzes biological samples.
- Performance Studies: The performance studies focus on filtration efficiency, fluid resistance, breathing resistance, flammability, and biocompatibility – all characteristics of a protective barrier device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MSH
Device 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.
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
operating room personnel
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)
Not Found
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
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 772-778-0240 FAX izzdrok@aol.com 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.
1
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.
2
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 | |
| contacting materials | Cytotoxicity Agar Overly Sensitization |
| 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
3
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 | |
| Loop | 12 Long 10 Short Inches | |
| Facepiece Length | 7.0 Inches | 7.0 Inches |
Mask Style
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4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
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.
5
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
6
Image /page/6/Picture/0 description: This image shows the logo of the U.S. Food and Drug Administration. The text "U.S. Food and Drug Administration" is prominently displayed, along with the text "CENTER FOR DEVICES AND RADIOLOGICAL HEAL". At the bottom of the image, there is a navigation bar with links to "FDA Home Page", "CDRH Home Page", "Search", "CDRH A-Z Index", and "Contact CDRH".
Manchester United
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
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
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