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Absorbent core material |
100 % purified cotton and/or rayon |
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Absorbency |
To be measured using the Syngina absorbency protocol (one droplet: light flow < 6 grams, two droplets: 6 to 9 grams, three droplets: 9 to 12 grams, regular flow) as per 21 CFR 801.430(f) |
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Cover or overwrap |
Thin, non-woven 100% cotton or polypropylene layer attached to the surface of absorbent core to facilitate removal |
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Withdrawal cord |
Stitched or knitted cotton with polypropylene braid
Must be suitably sewn with a polyester thread to the absorbent core to ensure safe and efficient removal |
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Applicator |
To help comfortably inserting the tampon.
If present, model and material to be described by supplier.
If a plastic applicator is supplied, it must be guaranteed BPA (Bisphenol A) free |
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Fragrance |
No fragrance or deodorants |
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Packaging |
Individual paper, cellophane or polypropylene packaging to ensure hygienic quality of the product is maintained prior to use |
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Component Materials |
Supplier will guarantee tampons to be free of 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)/2,3,7,8-tetrachlorofuran dioxin (TCDF) and any pesticide and herbicide residues.
For any materials bleached during processing, the bleaching process used will be described, e.g., Elemental Chlorine-Free (ECF) or Totally Chlorine-Free (TCF). |
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Toxicology |
Supplier will provide biocompatibility data resulting from testing as described in the guidance “Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing”, for repeat use devices--30 days or more-- in contact with skin/mucosal membrane surface |
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Microbiology |
Supplier will provide evidence that the tampon, in its final manufactured form, does not enhance the growth of Staphylococcus aureus, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) or alter the growth of normal vaginal microflora |
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Notice |
Each pack of tampons must be provided with a set of instructions, which give clear advice and guidance on the correct use of the tampons.
The information should be clear and legible and in the language of the country of distribution.
The notice will provide important information regarding Toxic Shock Syndrome (TSS), inform consumers that TSS is potentially fatal, provide a full description of the symptoms of TSS, instruct the users to consult a doctor if the symptoms of TSS occur, limit wear-time per tampon to no more than 4 hours and advise against the use of tampons “overnight”, as well as general user instructions on the method for insertion and withdrawal of the tampon, advise to use the lowest absorbency/size to suit the flow, provide a full description of all the absorbencies/sizes available linking them to the menstrual flow, provide a statement on frequency of use, emphasize the importance of personal hygiene, inform the user to only use one tampon at a time and advise the user to ensure the removal of the last tampon once menstruation has finished |
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Packaging |
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Primary pack |
Carton box of 10 individually packaged tampons |
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Labelling on primary pack |
Clear and durable marking with: product name, manufactured by: name and address, country of origin, production date and batch number.
Each pack of tampons must be labelled with the appropriate number of droplets to denote the range of Syngina absorbency. The droplets should be placed in a prominent position either on the front or top of the pack. The droplets will have a minimum size of 3 mm for the smallest packs and will be scaled up as appropriate for larger packs |
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Secondary packing |
Export cardboard box 5 plies. Closed with long lasting tape or glued flaps. Box size to be tightly adjusted to content. Marking as specified in contract. |
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Transport packing |
Pallets of n boxes, with shrink-wrapped plastic film. Pallet type and size as mentioned in contract. Supplier to indicate the pallet pattern and number of boxes per pallet as part of the contract. |