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K Number
K013086
Device Name
WET LIGHT PERSONAL MOISTURIZER
Manufacturer
TRIGG LABORATORIES, INC.
Date Cleared
2001-12-13

(90 days)

Product Code
HIS
Regulation Number
884.5300
Type
Traditional
Panel
OB
Reference & Predicate Devices
K013060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

WET® Light Personal Moisturizer is intended for which Bight refections. It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.

Device Description

Not Found

AI/ML Overview

The provided text primarily consists of a 510(k) clearance letter from the FDA for the "WET® Light Personal Moisturizer" and "WET® Flavored Personal Moistures (5 Flavors)". This document focuses on the regulatory approval process and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information as the input document does not contain details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
  6. Standalone device performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not a scientific study report demonstrating performance against specific acceptance criteria.

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.