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NIOSH Certification for N95 Respirator
NIOSH Certification also is known as the National Institute for Occupational Safety and Health Certification. NIOSH approval, and certification assuring respirators and Protective Clothing used in the workplace meet the standards. COVID 19 Respirators to follow 42 CFR Part 84 standards. NIOSH Certification can be taken for those designs, manufactures, assembles, or controls the assembly of a respirator and protective clothing
Surgical N95 Respirator and FDA 510k Clearance
Surgical N95 Respirator Face Mask under FDA Product Code MSH must undergo NIOSH Certification before FDA 510k application and clearance. General N95 face mask (without Virus/ Bacteria protection claim ) under product code MSH can be directly registered and listed without 510k and NIOSH.
- More information about FDA 510k >>
- Applicable Fees and the timeline for 510k Clearance >>
N95 Respirator
An N95 is a respiratory protective Face Mask designed to achieve a very close facial fit and blocks at least 95% of tiny (0.3 microns) airborne particles. The “N” stands for “Not resistant to Oil,”
N95 Respirator Face Mask NIOSH Certification Process
Step I: Appoint Consultant
Asses the N95 manufactured conforms to the requirements of 42 CFR Part 84 and check the capability of the manufacturer to develop the technical inputs. The consultant will choose the type of application.
Step 2: Get the three-character manufacturer's code from NIOSH.
Based on the type of N95 and type of application, the three-character code must be received for further processing.
Step 3: Get the standard application form.
The application will be processed by consultants jointly with the client team and submitted by electronic media. All necessary documents also must be submitted along with the application as specified in CFR.
Step 4: Get Respirator tested.
All test samples must identified appropriately and marked as per application reference number and packed as per the relevant protocol and submitted to NIOSH.
Step 5: Comply with QA documentation.
a. Design Drawings
b. Quality Control Plan
c. Sampling Plan
d. User Instructions
e. OOS specification
N95 NIOSH Certification Cost & Timeline
- Tentative Certification Fees Payable to Authorities: $ 13050
- Guidance & Technical Documentation : $ 19650
- Associated Testing: Mask without Valve $ 4500 and or Mask with Valve $ 5000
Note:
- The above fees are for a single N95 construction.
- Guidance fees are payable in 40:30:20:10 based on the project progress and testing fees in advance.
From our experience and present COVID 19 crisis, the estimated timeline is ten months.
Frequently Asked Questions!
How many samples are required for NIOSH N95 testing?
Thirty samples from each construction/design are required for testing.
Can I get the NIOSH Certification soon after Test Report?
NIOSH Certification is possible only after successful testing of the device and following the conduct of Quality Audit at a manufacturing location to get the final certificate. The NIOSH Certification authority only can issue a certificate, not by any third-party agency.
Do we need to submit Pre-Submission? What data to include in Pre-submission?
Yes, Pre-submission is required. Performance test data and statements must be included.
What are the test to be performed for N95 & N99 Respirators?
The following are the mandatory testing for NIOSH Certification;
1. Determination of Exhalation Resistance.
2. Determination of Exhalation Valve Leakage.
3. Determination of Inhalation Resistance.
4. Determination of Particulate Filter Efficiency Level for P100 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
5. Determination of Particulate Filter Efficiency Level for P99 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
6. Determination of Particulate Filter Efficiency Level for P95 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
7. Determination of Particulate Filter Efficiency Level for R100 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
8. Determination of Particulate Filter Efficiency Level for R99 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
9. Determination of Particulate Filter Efficiency Level for R95 Series Filters Against Liquid Particulates for Non-Powered Air-Purifying Respirators.
10. Determination of Particulate Filter Efficiency Level for N100 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
11. Determination of Particulate Filter Efficiency Level for N99 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
12. Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-Powered Air-Purifying Respirators.
How will we be able to sell Surgical Respirator (N95) in the United States?
A Surgical Respirator (N95) is a NIOSH approved respirator with additional 510k clearances from FDA. Surgical respirators can be used during surgical procedures.
Is Device drawings should be submitted? What format?
Yes, the drawing must be submitted in English in PDF, Coral draw, Autodesk clearly identified 3 digit manufactures code.
Is manufacturer must provide vendor qualification documents?
If the manufacturer controls all specifications for the component, the component vendors do not need to be specified. If the manufacturer does not determine all specifications of the component, then the applicant must provide the name of the vendor, this is mandatory for NIOSH Certification.
Should the manufacturer submit product label / Information panel sample?
Yes, the manufacturer must submit Labels along with user instructions.
What are the NIOSH Application Criteria?
The federal rule 42 CFR 84 establishes minimum standards for the approval of respiratory protection devices. The procedure for submitting an application must also be followed.