Global FDA 510k Consultants

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

510k for Surgical Gown, Examination Glove & 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.

FDA CODE: LZA (Nitrile Examination Gloves)

FDA CODE: LYY (Latex Examination Gloves)

		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

We also support manufacturers with biocompatibility and performance testing for Gloves.

For the inclusion of a product code, an additional cost of 4000 USD will be charged.

Biocompatibility testing: 5500 USD in 100-120 days. ( 32 samples for testing)
Performance testing as per ASTM: 2700 USD in 35 days. ( 300-350 samples for testing from the same batch)

FDA CODE – FXX / OUK

#	Activity	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	X	√
7	Establishment Registration and Device Listing post 510(k) clearance	√	√	√
	Total Fees OUK Product Code : 40% extra Fees applicable	$ 3000 € 26000 ₹ 200000	$7000 € 5900 ₹ 400000	$ 13000 € 12000 ₹ 950000

FDA CODE – FMF (Piston Syringe)

FDA CODE – FMI (Disposable Hypodermic Syringe)

FDA CODE – FMI + FMF (Disposable Hypodermic Syringe with Piston)

		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	X	√
7	Establishment Registration and Device Listing post 510(k) clearance	√	√	√
	Total Fees (Multiple Codes 30% extra)	$ 5500 € 5000 ₹ 400000	$9500 € 9000 ₹ 800000	$ 22000 € 21000 ₹ 1600000

FDA CODE: FYA (Surgical Gown)

FDA CODE: FYC (Surgical Isolation Gown)

		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	X	√
7	Establishment Registration and Device Listing post 510(k) clearance	√	√	√
	Total Fees	$ 3500 € 3000 ₹ 250000	$7500 € 6000 ₹ 550000	$ 16000 € 14000 ₹ 1200000

Note:

Price quoted for Single Design, Single material of Construction, Single product Code device.
Any deviation from the above is considered as a separate device and a 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 avoiding travel and use alternate methods such as Zoom /Skype /WhatsApp for meetings.
We keep delay fees for both client and customer for undue relay for silly reasons.
FDA 510k Review Fees (1st Oct 2021- 30th Sep 2022) is $12745 (standard) and or $3186 (small Business)
Biocompatibility and Performance testing additional and needs to budget separately
Tentative Timeline : FDA 510k preparation & Testing 3-4 months. FDA Review & approval 6-9 months.