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K Number
K980395
Device Name
GLADRAGS COTTON MENSTRUAL PAD
Manufacturer
KEEPERS!, INC.
Date Cleared
1998-04-16

(73 days)

Product Code
HHD
Regulation Number
884.5435
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.

Device Description

GladRags Cotton Menstrual Pads

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device: "GladRags Cotton Menstrual Pad." This type of document is a regulatory clearance for a device based on substantial equivalence to a predicate device, not a study report demonstrating acceptance criteria based on performance.

Therefore, the document does not contain any of the requested information regarding acceptance criteria or a study proving the device meets them. This includes:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number/qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study results.
  • Standalone performance.
  • Type of ground truth used.
  • Sample size for training set.
  • How ground truth for the training set was established.

The FDA 510(k) process for a Class I device like the GladRags Cotton Menstrual Pad typically relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device characteristics (materials, design, intended use) and safety, rather than extensive clinical performance studies with specific performance metrics and acceptance criteria as would be expected for higher-risk devices or novel technologies.

§ 884.5435 Unscented menstrual pad.

(a)
Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.