YSANPOINT) (MENSTRUAL) DIGITAL TAMPON

K962712 · Talbot S. Lindstrom · HEB · Sep 10, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962712
• Device Name: YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
• Applicant: Talbot S. Lindstrom
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The SanPoint digital tampon is used to absorb menstrual and other vaginal discharges, when inserted in the vagina.

Device Story

Digital tampon for feminine hygiene; absorbs menstrual and vaginal discharges. Composed of 75% non-chlorine bleached rayon viscose and 25% non-chlorine bleached cotton absorbent core; non-woven cover of thermobonded rayon-polypropylene; 100% non-chlorine bleached cotton removal string. Used by patients for self-care. Patented technique utilizes hydrophilic fibers in addition to thermoplastic fibers in the non-woven envelope fabric. Intended for private brand marketing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbent core: 75% non-chlorine bleached rayon viscose, 25% non-chlorine bleached cotton. Cover: thermobonded rayon-polypropylene non-woven fabric (no chemical binder). Removal string: 100% non-chlorine bleached cotton. Patented hydrophilic fiber integration in envelope.

Indications for Use

Indicated for use by females for the absorption of menstrual and other vaginal discharges.

Regulatory Classification

Identification

An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Predicate Devices

• Kotex (Kimberly-Clark Corp.)
• O.B. (Johnson & Johnson)

Submission Summary (Full Text)

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SanPoint
K962712
SEP 10 1996

Your ref
Our ref
Mariefred
July 2, 1996

# 510(K) SUMMARY

SanPoint AB, Bergåsa Industriområde, P.O.Box 55, S-647 22 Mariefred, Sweden, telephone [phone], fax [phone], here represented by

Talbot S. Lindström, Advokatfirman Delphi, Sergels Torg 12, P.O.Box 1432, S-11184 Stockholm, Sweden, telephone [phone], fax [phone],

has been a manufacturer of digital tampons since 1974, and was the first to introduce a 100% cotton tampon in 1988.

The subject of this submittee’s summary is a: ”digital tampon for feminine hygiene”. It is of essentially the same make and construction as the brand ”Kotex” manufactured by Kimberly-Clark Corp. and "O.B." manufactured by Johnson & Johnson, currently sold in the US and which are approved by the FDA. The only distinguishing characteristic is the use of a patented technique for the use of hydrophilic fibers in addition to thermoplastic fibers in the non-woven fabric of the envelope.

The SanPoint product comprises a digital tampon with the absorbant material being 75 % non-chlorine bleached rayon viscose, 25 % non-chlorine bleached cotton, with a non-woven cover of thermobonded rayon-polypropylene (without chemical binder), and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a 100 % non-chlorine bleached cotton string attached, enabling the user to remove the tampon after use.

An adequate instruction for use, as well as a clear warning for TSS, will accompany each package.

The purpose of this submitment is to enable SanPoint AB to market its product in the US as private brands.

(Signature of Certifier)
Hans Feikes de Groot
(Typed name)
July 2, 1996
(Date)

(Premarket Notification 510(k) No)

Sag.no 00000-6761
SanPoint AB, P.O. Box 55, S-647 22 Mariefred, Sweden, Phone [phone], Telefax [phone]