(161 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a respirator mask, with no mention of AI or ML technology.
No.
A surgical mask is not considered a therapeutic device as its primary function is protection from the transfer of microorganisms, body fluids, and particulate material, rather than treating or curing a medical condition.
No
The device is a respirator mask used for protection, not for diagnosing a disease or condition.
No
The device description clearly outlines physical components like nonwoven material, filter media, rubber headband, foam, and aluminum, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction of a mask designed for filtration and barrier protection. It does not mention any components or mechanisms for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's filtration efficiency, resistance to liquid penetration, breathing resistance, and skin irritation. These are all related to its function as a protective barrier and respirator, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask 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
MSH
Device Description
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Makrite Type N95 Healthcare Respirator and Surgical Mask Model 910-N95 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-3323 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.
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
This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-3323.
Tests Performed:
- Department of Health and Human Services 42CFR 84 Type N95 Requirements. Laboratory: NIOSH
- Resistance of Liquid (Synthetic Blood Penetration Resistance) ASTMF 1862-00. Laboratory: Nelson Laboratories
- Breathing Resistance 42CFR84. Laboratory: NIOSH
- Filtration Efficiency NIOSH 42 CFR 11. Laboratory: NIOSH
- Irritation: Primary Skin FHSA Skin Sensitization. Laboratory: Nelson Laboratories
Key Metrics
95% efficiency against a .3 micron particulate
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 2 3 2002
510(K) Summary
Submitter Joseph Z. Zdrok & Associates 24 Tower St. Webster, MA 01570
Contact Joseph Z. Zdrok President 508-943-4895 Telephone 508-671-9144 FAX E-Mail jzzdrok@aol.com
Date Jan. 31, 2002
Trade Name Makrite Type N-95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95
Common Name: Healthcare Particulate Respirator and Surgical Mask
Classification Device Class - Class II CFR Section - 21 CFR 878.4040
Substantial Equivalency:
The Makrite Model 910-N95 Heathcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to the Gerson Isolair APR Type N95 Mask Model 2735 (510(K)K960778). Both products have been tested and approved by NIOSH as N-95 respirators.
2
1
510(K) Summary (Continued)
USE
Description:
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Makrite Type N95 Healthcare Respirator and Surgical Mask Model 910-N95 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-3323 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.
Intended Use:
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-95 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 preciously cleared device is white. The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask Model is also white. The headband color of the cleared device is green and the Makrite Model 910-N95 is yellow.
2
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask incorporates a highly efficient filer 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) K960778 is manufactured from similar materials.
Performance Tests:
This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-3323.
| Tests Performed | Laboratory | |
|---|---|---|
| 1. | Department of Health and Human | |
| Services 42CFR 84 Type N95 | ||
| Requirements | NIOSH | |
| 2. | Resistance of Liquid (Synthetic | |
| Blood Penetration Resistance) | ||
| ASTMF 1862-00 | Nelson Laboratories | |
| 3. | Breathing Resistance 42CFR84 | NIOSH |
| 4. | Filtration Efficiency NIOSH 42 CFR 11 | NIOSH |
| 5. | Irritation: Primary Skin FHSA | |
| Skin Sensitization | Nelson Laboratories |
Conclusion:
Since the basic construction is used in the cleared device as in the new device and approved by NIOSH, the Makrite 910-95 Healthcare Particulate Respirator and Surgical Mask is substantially equivalent to the Gerson Model 2735 Healthcare and Particulate Respirator and Surgical Mask.
Safety/Effectiveness
The device has a filtration equivalent to the previously cleared Gerson Model 2735 Surgical Mask Respirator. It is NIOSH approved and meets the CDC guidelines for TB Exposure Control.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Makrite Industries, Incorporated C/O Mr. Joseph Zdrok Joseph Z. Zdrok & Associates 24 Tower Street Webster, Massachusetts 01570
Re: K020474
Trade/Device Name: Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: May 28, 2002 Received: May 31, 2002
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.
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.
4
Page 2 - Mr. Zdrok
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Nunber (if known): __ K020474_
Device Name: Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask
Indications For Use:
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask 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.
FDA/CDRH/ODE/DHG
MAR 25 'L 20 PM '02
RECEIVED
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formst 1-2-96)
Rassidy for Clan
Division of Dental, Infection Control, and General Hospital Devices E10(k) Number K020474