(14 days)
E-Z Lubricating Jelly is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
E-Z Lubricating Jelly (sterile) is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field Is required.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "E-Z Lubricating Jelly". It primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device.
Therefore, this document does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
The FDA letter confirms that the device is substantially equivalent for its intended use, which is "to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices," and "when a sterile field is required" for the sterile version.
The information requested in the prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) would typically be found in a separate study report or the technical documentation submitted by Chester Labs, Inc. to the FDA, not in the FDA's clearance letter itself.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.