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K Number
K971174
Device Name
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
Manufacturer
PLAYTEX, INC.
Date Cleared
1997-05-21

(51 days)

Product Code
HEB
Regulation Number
884.5470
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Unscented menstrual tampons for the absorption of menstrual fluid.

Device Description

Unscented menstrual tampons for the absorption of menstrual fluid.

AI/ML Overview

The provided text describes a 510(k) submission for Playtex Tampons, specifically addressing their substantial equivalence to previously cleared Playtex Gentle Glide Tampons. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

  • Device Name: Playtex Tampons (Unscented Menstrual Tampons)
  • Predicate Device: Previously cleared Playtex Gentle Glide Tampons, Regular, Super and Super Plus.
  • Intended Use: Unscented menstrual tampons for the absorption of menstrual fluid.
  • Technological Characteristics: The new tampon has the same technological characteristics as the predicate device (fiber, string, materials in contact with the vaginal wall, and mode of action are the same).
  • Nonclinical Testing: Dioxin analysis, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing.
  • Conclusion: The Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness based on the review of the data.

Therefore, I cannot populate the table or provide information for the specific points you requested, as the document focuses on demonstrating substantial equivalence rather than reporting on specific performance acceptance criteria from a study.

The document indicates that the determination of safety and effectiveness was based on the nonclinical testing mentioned above and a comparison to the predicate device. It does not describe a clinical study with a test set, ground truth, or statistical analysis of performance metrics against predefined acceptance criteria for the new device.

§ 884.5470 Unscented menstrual tampon.

(a)
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.(b)
Classification. Class II (performance standards).