Friday, August 17, 2012

FDA Approval for Tencel in Medical Swabs (1991)

Solvent residues in Tencel were making some nonwoven hygiene product makers cautious about developing products with the new fibre. This led us to apply for FDA pre-market approval for general purpose swabs made out of "raw" needled Tencel staple. These were then sterilized and packed and submitted to the FDA for testing against a control batch of commercial J&J swabs made of viscose.  The record below gives us the dates of submission and approval on the basis of "substantial equivalence" to the commercial viscose product. 

After this (in 93) we repeated the exercise with a more critical operating-room swab construction used in body cavities during surgery.   Later still (in 97) the process was repeated this time to clear Tencel for use in an occlusive burn dressing.  Both of these gained FDA approval also.

Courtaulds Research's Focus Polymers unit (who were making wound dressings from alginate nonwovens) made, sterilised and packed the swabs for these trials and I think it was Tom Burrow who recommended we used Evan Dick as the consultant to interface with the FDA.  Evan was based in St Louis where Bob Feil, Glyn Raven and I visited him in 91 to set things moving.  I asked Glyn Raven if he remembered the visit.  His recollection follows as a comment. (Click comment below to see it)

FDA 510(k) Application Details - K921227

Device Classification NameGauze, External (With Drug/Biologic/Animal Source Material)

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510(K) NumberK921227
P.O. BOX 141
AXIS, AL 36505
Other 510(k) Applications for this Company

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Other 510(k) Applications for this Contact
Regulation Number000.0000

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Classification Product CodeGER
Other 510(k) Applications for this Device

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Date Received03/13/1992
Decision Date05/29/1992
DecisionSE - Substantially Equivalent
Classification Advisory CommitteeSU - General & Plastic Surgery
Review Advisory CommitteeSU - General & Plastic Surgery

1 comment:

Glyn Raven said...

Calvin How could i forget that night!! Yes of course the business was about getting FDA approval for Tencel in a medical wipe but the hotel incident comes clearer to mind R Feil had noticed a 12 / 15 and 24 year old collection of The Macallan in the bar and we negotiated a half portioin of each for a collective price then spent about 15 mins deciding which way to go We agreed in the end to go youngest first then up to the 24 yr old I've never forgiven Bob for teaching me that 12 year old Macallan tastes like Bells next to a 24 year old ! I think That was also the trip when we visited Phillip Morris to explore the use of fibrillated hydroentangled Tencel in a cigarette filter tip. Again i will never forget the visit Signs everywhere saying PLease Smoke and the official "tasters" taking the biggest drag out of a ciggy that I have ever seen then swirling it around in their mouths like a fine wine - I nearly puked!! I hate cigarette smoke I think the end result was a potential 0.001 cents increase in unit cost which apparently was a killer in the ciggy business so it did not proceed thank God !

Lots more where that came from lets stay in touch