Follow Us:

US FDA

Home FDA 510k Consultancy Services
Global FDA 510k Consultants

Know more about I3CGlobal team capabilities, responsibilities type of services and past histories in 510(k) Consultation Services.

PPE 510k Consultants

Surgical Gowns, Examination Gloves, N95, Surgical Face Mask

Website viewers across the globe are eager to know what all items inside a PPE kit need 510k, what is the role of consultants in getting a 510k clearance and how much would be the estimated pricing. Our estimates are almost correct and we do not bill you extra for any additional effort. This is our promise!!. We will not ditch you halfway.

SURGICAL FACE MASK : FDA CODE FXX

 

Experienced Clients

Experienced but new to this device

First Timers with no experience

1

MDFUSC (FDA Form 3601)

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

510(k) Cover Letter

Acceptance checklist

Indication For Use Statement (FDA Form 3881)

Truthful and Accuracy Statement

Class III Summary and Certification

Financial Certification or Disclosure statement

Declarations of Conformity and Summary report

X

X

2

510(k) Summary

Executive Summary

X

3

Device Description

Substantial Equivalence Discussion

Proposed Labelling

Sterilization and Shelf life

Biocompatibility Testing

Software

Electromagnetic Compatibility and electrical safety

Performance Testing- Bench

Performance Testing- Animal

Performance Testing- Clinical

Risks to Health

Device Drawing

Sterilizer Validation Protocol and Report

Shelf Life Study Protocol and Report

Biocompatibility Test Protocol and Report

Labelling

Mfg. Flow Chart

Risk Management

Packaging Integrity Test Protocol and Report

Test Protocols and Report

X

4

US Agent  Service (With or Without Pre- Submission).

US Agent Service  with document compilation and review of 510k file before submission.

5

FDA Application and FDA Payment gateway support.

6

Answering to FDA review comments and modify 510k by providing additional supporting documentary evidence as per FDA review comments

X

7

Establishment Registration and Device Listing post 510(k) clearance

 

Total Fees 

 

$ 3000

€ 26000

₹ 200000

$7000

€ 5900

₹ 400000

$ 13000

€ 12000

₹ 950000

N95 RESPIRATOR : FDA CODE : MSH

NIOSH Certification is mandatory for 510k.

 

Experienced Clients

Experienced but new to this device

First Timers with no experience

1

MDFUSC (FDA Form 3601)

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

510(k) Cover Letter

Acceptance checklist

Indication For Use Statement (FDA Form 3881)

Truthful and Accuracy Statement

Class III Summary and Certification

Financial Certification or Disclosure statement

Declarations of Conformity and Summary report

X

X

2

510(k) Summary

Executive Summary

X

3

Device Description

Substantial Equivalence Discussion

Proposed Labelling

Sterilization and Shelf life

Biocompatibility Testing

Software

Electromagnetic Compatibility and electrical safety

Performance Testing- Bench

Performance Testing- Animal

Performance Testing- Clinical

Risks to Health

Device Drawing

Sterilizer Validation Protocol and Report

Shelf Life Study Protocol and Report

Biocompatibility Test Protocol and Report

Labelling

Mfg. Flow Chart

Risk Management

Packaging Integrity Test Protocol and Report

Test Protocols and Report

X

4

US Agent  Service (With or Without Pre- Submission).

US Agent Service  with document compilation and review of 510k file before submission.

5

FDA Application and FDA Payment gateway support.

6

Answering to FDA review comments and modify 510k by providing additional supporting documentary evidence as per FDA review comments

X

7

Establishment Registration and Device Listing post 510(k) clearance

 

Total Fees 

 

$ 3500

€ 25000

₹ 250000

$8000

€ 6500

₹ 600000

$ 18000

€ 16000

₹ 1350000

GOWN

SURGICAL GOWN : FDA CODE FYA
NON STERILE ISOLATION GOWN : FDA CODE OEA

 

Experienced Clients

Experienced but new to this device

First Timers with no experience

1

MDFUSC (FDA Form 3601)

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

510(k) Cover Letter

Acceptance checklist

Indication For Use Statement (FDA Form 3881)

Truthful and Accuracy Statement

Class III Summary and Certification

Financial Certification or Disclosure statement

Declarations of Conformity and Summary report

X

X

2

510(k) Summary

Executive Summary

X

3

Device Description

Substantial Equivalence Discussion

Proposed Labelling

Sterilization and Shelf life

Biocompatibility Testing

Software

Electromagnetic Compatibility and electrical safety

Performance Testing- Bench

Performance Testing- Animal

Performance Testing- Clinical

Risks to Health

Device Drawing

Sterilizer Validation Protocol and Report

Shelf Life Study Protocol and Report

Biocompatibility Test Protocol and Report

Labelling

Mfg. Flow Chart

Risk Management

Packaging Integrity Test Protocol and Report

Test Protocols and Report

X

4

US Agent  Service (With or Without Pre- Submission).

US Agent Service  with document compilation and review of 510k file before submission.

5

FDA Application and FDA Payment gateway support.

6

Answering to FDA review comments and modify 510k by providing additional supporting documentary evidence as per FDA review comments

X

7

Establishment Registration and Device Listing post 510(k) clearance

 

Total Fees 

 

$ 3500

€ 3000

₹ 250000

$7500

€ 6000

₹ 550000

$ 16000

€ 14000

₹ 1200000

EXAMINATION & SURGICAL GLOVES

LATEX / VINYL / NITRYL EXAMINATION GLOVES : FDA PRODUCT CODE – LYY / LYZ / LZA
LATEX SURGICAL GLOVES : FDA PRODUCT CODE – KYO

Experienced Clients

Experienced but new to this device

First Timers with no experience

1

MDFUSC (FDA Form 3601)

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

510(k) Cover Letter

Acceptance checklist

Indication For Use Statement (FDA Form 3881)

Truthful and Accuracy Statement

Class III Summary and Certification

Financial Certification or Disclosure statement

Declarations of Conformity and Summary report

X

X

2

510(k) Summary

Executive Summary

X

3

Device Description

Substantial Equivalence Discussion

Proposed Labelling

Sterilization and Shelf life

Biocompatibility Testing

Software

Electromagnetic Compatibility and electrical safety

Performance Testing- Bench

Performance Testing- Animal

Performance Testing- Clinical

Risks to Health

Device Drawing

Sterilizer Validation Protocol and Report

Shelf Life Study Protocol and Report

Biocompatibility Test Protocol and Report

Labelling

Mfg. Flow Chart

Risk Management

Packaging Integrity Test Protocol and Report

Test Protocols and Report

X

4

US Agent  Service (With or Without Pre- Submission).

US Agent Service  with document compilation and review of 510k file before submission.

X

5

FDA Application and FDA Payment gateway support.

6

Answering to FDA review comments and modify 510k by providing additional supporting documentary evidence as per FDA review comments

X

X

7

Establishment Registration and Device Listing post 510(k) clearance

 

Total Fees 

 

$ 3000

€ 2700

₹ 200000

$7000

€ 5900

₹ 500000

$ 15000

€ 13000

₹ 1100000

Note:

  • Price quoted for Single Design, Single material of Construction, Single product Code device.
  • Any deviation in above is considered as separate device and separate 510k application to be filled.
  • Consultant travel to client location will be charged for airline travel & accommodation for a maximum of 3 man-days.
  • We recommend to avoid travel and use alternate methods such as Zoom /Skype /WhatsApp for meetings.
  • We keep a delay fees for both client and customer for undue relay for silly reasons.

More information about FDA Product Codes and Requirements.