FDA.reportPublic FDA data

Astroglide Ultra Gentle Gel

Primary DI
00015594011035
Brand
Astroglide Ultra Gentle Gel
Company
BIOFILM, INC
Model
015594011035
Catalog number
N/A
Device description
Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Published
2023-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220355000Astroglide Ultra Gentle GelBiofilm, Inc.2022-05-26NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015594011035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015594011035000155940110350155940110350015594011035

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight85Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature70 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-848-5900customer.service@biofilm.com

Regulatory Flags#

DUNS number
790780258
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015594000015Astroglide Sensual Strawberry Personal Lubricant015594000015N/A2025-07-05
00015594000046Astroglide X Silicone Liquid015594000046N/A2025-07-05
00015594012148Astroglide Gel Personal Lubricant0155940121482024-08-21
00015594012094Astroglide X Silicone Liquid0155940120942023-08-29
00015594011653Astroglide Organix Liquid015594011653N/A2023-06-10
00015594011813Astroglide Ultra Gentle Gel015594011813N/A2023-06-10
00015594011837Astroglide X Silicone Liquid015594011837N/A2023-06-10
00015594011929Astroglide Toy 'N Joy Personal Lubricant0155940119292023-06-10
00015594011769Astroglide X Premium Silicone Gel Personal Lubricant0155940117692023-06-07
00015594011776Astroglide Glycerin & Paraben Free Personal Lubricant015594011776NA2023-06-07
00015594011844Astroglide O Oil Massage Oil & Personal Lubricant015594011844N/A2023-06-07
00015594011851Astroglide Gel Personal Lubricant015594011851N/A2023-06-07
00015594012056Astroglide Sensual Strawberry Personal Lubricant0155940120562023-06-07
00015594010632Astroglide Glycerin & Paraben Free0155940106322022-02-15
00015594011882Astroglide Toy N Joy0155940118822022-02-15
00015594011967Astroglide Quiver0155940119672022-02-15
00015594010342Astroglide Warming Liquid Personal Lubricant0155940103422016-09-13
00015594010540Astroglide Sensual Strawberry Personal Lubricant0155940105402016-09-13
00015594010861Astroglide X Silicone Liquid0155940108612022-02-15
00015594011639Astroglide Organix Liquid0155940116392022-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01