FDA.reportPublic FDA data

Harmony Latex Dams

Primary DI
00726893120617
Brand
Harmony Latex Dams
Company
GLOBAL PROTECTION CORP.
Model
PHA202U
Device description
Latex Prophylactic Dams
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSCBarrier, Std, Oral Sex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSCBarrier, Std, Oral SexObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00726893120617PrimaryGS10
80726893120613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00726893120617007268931206177268931206170726893120617
8072689312061380726893120613

GMDN Terms#

Term, Definition table
TermDefinition
Oral/vaginal sex barrier, Hevea-latexA device in the form of a flat sheet (a rubber dam), composed of Hevea-latex, designed to help reduce the risk of catching/spreading sexually transmitted infections (STI), also known as sexually transmitted diseases (STD), such as syphilis, gonorrhoea, Chlamydia infections, genital herpes, and acquired immune deficiency syndrome (AIDS ) during oral-vaginal sexual activity. It is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including the anus. It is held in place by one of the sexual partners and may be moistened with a commercially available lubricant to enhance performance. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
100
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
00726893120365One Lux11320062026-06-08
00726893120594Harmony Latex DamPHA202R2026-06-08
00726893120600harmony Non- Latex damsPHA101U2026-06-08
00726893120730One Lux11330062026-06-08
00726893120747One Lux11340062026-06-08
00726893120778One Unity Collection11600BY2026-06-08
00726893120945One Lux113200B2026-06-08
00726893120952One Lux113300B2026-06-08
00726893120969One Lux113400B2026-06-08
00810124865085Adam and Eve hard rider99PHE200C2026-06-08
00860015576620Swoon Ultra Thin99SWON2022026-06-08
10860015576603Swoon Ultra Thin99SWON200C2026-06-08
00726893120587Harmony non-Latex DamPHA101R2026-06-04
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28
20726893120680One Classic Select11000BC2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120594Harmony Latex DamGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120600harmony Non- Latex damsGLOBAL PROTECTION CORP.MSC2026-06-08
00726893120587Harmony non-Latex DamGLOBAL PROTECTION CORP.MSC2026-06-04
09555514012991SancDam™SANCTUARY HEALTH SDN. BHD.MSC2025-02-13
29555514012995SancDam™SANCTUARY HEALTH SDN. BHD.MSC2025-02-13
00726893118324LTS Safer Sex KitGLOBAL PROTECTION CORP.MSC2025-01-06
00726893118416Custom CondomsGLOBAL PROTECTION CORP.MSC2025-01-06
00628347062736Harmony Latex Single SleevePamco Distributing IncMSC2024-05-30
00628347062774Harmony Polyisoprene Single SleevePamco Distributing IncMSC2024-05-30
09555514001391SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514001407SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011383SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011413SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
09555514011420SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514001398SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514001404SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011380SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011410SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
19555514011427SancDam™SANCTUARY HEALTH SDN. BHD.MSC2023-10-20
00726893114913Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
00726893115101Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
80726893114919Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
80726893115107Satin DamsGLOBAL PROTECTION CORP.MSC2023-07-07
00850049875004LoralsBrazen Goods Inc.MSC2023-02-04
00850049875011LoralsBrazen Goods Inc.MSC2023-02-04
00860008392183LoralsBrazen Goods Inc.MSC2023-02-04
00860008392190LoralsBrazen Goods Inc.MSC2023-02-04
00860008392169LoralsBrazen Goods Inc.MSC2022-12-19
00860008392176LoralsBrazen Goods Inc.MSC2022-12-19
00860008392145LoralsBrazen Goods Inc.MSC2022-08-12