Exam Room Astroglide Target Lubricating Jelly
FDA 510(k)Class II (US FDA 510(k))
by Biofilm, Inc
Identifiers
- 510(k) Number
- K003867 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a personal lubricant classified under the nomenclature ‘Lubricant, Personal.’ It is designed to reduce friction and discomfort during gynecological and hospital procedures, as well as for personal use in cases of vaginal dryness. The lubricant is formulated to be non-harmful to rubber appliances and medical instruments, ensuring compatibility with common clinical and household applications.
Supplied as a jelly, this lubricant is intended for single-use in both professional and consumer settings. It is not sterile and is regulated under FDA 510(k) clearance (K003867) with a classification of Class II. The product is distributed in various sizes and packaging, adhering to regulatory standards for personal lubricants (Regulation 884.5300). Authorized for obstetrics/gynecology use, it is supplied by Biofilm, Inc., based in Vista, CA.
Frequently asked questions
What is the Astroglide Exam Room Lubricant used for?
The Astroglide Exam Room Lubricant is designed to reduce friction and discomfort during gynecological and hospital procedures, such as pelvic exams. It is also intended for personal use in cases of vaginal dryness. Its formulation ensures compatibility with rubber medical instruments and appliances, making it suitable for clinical and household applications.
Is the Astroglide Exam Room Lubricant sterile?
No, the Astroglide Exam Room Lubricant is not sterile. It is classified as a non-sterile personal lubricant and is intended for single-use only, adhering to FDA regulatory standards for this type of product.
How is the Astroglide Exam Room Lubricant supplied?
The Astroglide Exam Room Lubricant is supplied as a jelly in various sizes and packaging formats. It is intended for single-use applications in both professional medical settings and consumer use, ensuring convenience and compliance with regulatory guidelines.
Can this lubricant be reused?
No, the Astroglide Exam Room Lubricant is explicitly designed for single-use only. Reusing it could compromise hygiene and effectiveness, particularly in clinical settings where sterility and safety are critical.
What regulatory approval does the Astroglide Exam Room Lubricant have?
The Astroglide Exam Room Lubricant holds FDA 510(k) clearance under the classification of Class II, with the clearance number K003867. This approval confirms its substantial equivalence to a predicate device and its compliance with FDA regulations for personal lubricants under product code NUC.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Exam Room Astroglide (Professional Market), Target Lubricating Jelly ..., EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET… - FDA.report, EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003867 | Class II | Active |
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Manufacturer
- Manufacturer
- Biofilm, Inc
- FDA Applicant
- Biofilm, Inc.
Sources (1)
- FDA 510(k) K003867 24 fields · synced Oct 1, 2026