SANPOINT MENSTRUAL TAMPON

K961926 · Sanpoint AB · HEB · Jul 15, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961926
• Device Name: SANPOINT MENSTRUAL TAMPON
• Applicant: Sanpoint AB
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a cotton string attached, enabling the user to remove the tampon after use.

Device Story

Digital tampon composed of 100% peroxide-bleached virgin cotton; includes attached cotton string for removal. Intended for vaginal insertion to absorb menstrual and vaginal discharges. Used by patients for feminine hygiene. Device functions as a passive absorbent barrier. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: 100% peroxide-bleached virgin cotton. Form factor: digital tampon with removal string. Non-sterile (implied by nature of product). No energy source, connectivity, or software.

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

• Natracare (FDA approved)

Submission Summary (Full Text)

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# SanPoint

JUL 15 1996

K96 1926

Your ref

Our ref

Mariefred

May 9, 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],

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

The subjects of this submittee’s summary are: ”digital all-cotton tampons for feminine hygiene”, and are of the same make and construction as the brand ”Natracare” currently sold by our distributor Body Wise (UK) Ltd., Bristol, with office in Denver, USA, on the US and Canadian market, items which are approved by FDA.

The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a 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.


Hans Feikes de Groot
(Typed name)

May 9, 1996
(Date)

(Premarket Notification 510(k) No)

Rev. no. 000005-4781