FDA.reportPublic FDA data

Reality

Primary DI
10019283927581
Brand
Reality
Company
MAYER LABORATORIES, INC.
Model
Ultra Thin
Catalog number
92758
Device description
Latex Condom 36-ct
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCONDOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K897129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K897129000CONDOMS (MULTIPLE BRANDS)Sagami, Inc.1990-05-16HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10019283927581PackageGS16In Commercial Distribution
20019283927588PackageGS14In Commercial Distribution
00719283927583PrimaryGS10
30019283927585Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001928392758110019283927581
2001928392758820019283927588
00719283927583007192839275837192839275830719283927583
3001928392758530019283927585

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(510)229-5300davidm@mayerlabs.com

Regulatory Flags#

DUNS number
175425982
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016169010248ThinKimono10242025-10-06
00016169030130MAXX Large FlareKimono MAXX030132025-10-06
00016169050404MicroThinKimono50402025-10-06
00016169070242MicroThin Ribbed + Sensi-DotsKimono70242025-10-06
00016169088032Kimono MicroThin XLKimono Microthin XL Condoms088032025-10-06
00016169114090Callvin RegularCallvin Latex Condom114092025-10-06
00016169114106Callvin GoldCallvin Latex Condom114102025-10-06
00016169114113PlaygroundPlayground Condoms114112025-10-06
00016169700057Nauox Yin YangNauox Yin Yang700052025-10-06
00016169700064Nauox Holy HoneyNauox Holy Honey700062025-10-06
00016169700071Nauox Dulce DreamsNauox Dulce Dreams700072025-10-06
00016169700088Nauox Sweet HavenNauox Sweet Haven700082025-10-06
00016169700095Naoux Agave NectarNaoux Agave Nectar700092025-10-06
00016169700194Femme GlydeFemme Glide Natural Lubriant700192025-10-06
00198715811087Kindra V LubeKindra Silicone Lubricant700182025-10-06
06279870714292NixitNixit Natural Lubricant700042023-11-03
00860004693543Pill ClubPeriod Care Reg Pads999-001-042022-02-09
00860004693550Pill ClubPeriod Care Super Pads999-001-052022-02-09
00860004693567Pill ClubPeriod Care Combo Pads999-001-062022-02-09
00860004693598Pill ClubPeriod Care Combo Tampons&Pads999-001-092022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
08859798108076LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798108083LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-13
08859798107871LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-12-03
19556807570843GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570867GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
19556807570881GlydeRICHTER RUBBER TECHNOLOGY SDN. BHD.HIS2025-12-02
08859798107260LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107277LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107284LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107291LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798107383LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-09-04
08859798104993PhillySURETEX LIMITED - BRANCHHIS2025-07-30
08859798105914LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106720LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106744LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
08859798106461LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-19
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106447LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106454LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106478LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18
08859798106485LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-18